Improving the Family Caregiving Relationship

grandmaToday families have become the foundation of long-term care for older persons living in the community. Studies have shown that as many as 80 percent of older adults rely solely on family members for care while less than 10 percent receive help from paid service providers. The vast majority of family caregivers, (80 percent), are middle-aged females and a wife over the age of 65 is most likely to serve as the caregiver for an impaired, older spouse living at home, followed by daughters over the age of 50, caring for a father. When these family members are not available, siblings, nieces, nephews, and grandchildren often step in to provide primary assistance.

Yet similar to the only partially joking statement that babies do not come with instruction manuals, neither do older individuals being cared for by family members. Additionally, while parenting classes now abound, classes in how to care for elderly parents or relatives, at the same time as children, spouses, and the caretaker themselves, are practically non-existent. Often, this situation becomes serious enough to severely effect a loving marital or familial relationship due to caregiver exhaustion and hopelessness over the chance of improvement in their circumstances. This can result in positive relationships deteriorating into an unhappy and unhealthy situation for everyone involved.

The possibility that these types of difficulties may develop is critical to consider before a family member may need such care. This is important for a number of reasons, one of the most significant being that without prior thought and planning, the effects of a caregiver situation on both parties can be devastating.

The accumulated findings speak to the reality of caring for a loved one:

Negative Patterns Exhibited by Caregivers

• Physical and emotional burnout is extremely common, causing the caregiver to be unable to care for themselves, or provide even minimal care for others.

• Burnout commonly leads to feeling overwhelmed, exhausted, and ill, until caregivers can no longer see beyond their own problems and become unable to view things from their loved one’s perspective.

• Burnout frequently results in the caretaker becoming unaware of making comments or behaving in ways that could hurt the one for whom they’re caring.

• Family caregivers frequently develop unrecognized resentment due to lost independence and the inability to exert control over their lives further eroding the quality of care they are able to provide.

Negative Patterns Exhibited by the Individual Receiving Care

• The person receiving care will often begin to respond to the care provider in a manner similar to how the provider is acting towards them.

• Resentment frequently develops in the individual receiving care resulting from the belief they’re being blamed for the situation in which they now find themselves

• Anger often results in those being cared for due to frustration over the loss of independence

Despite the fact that both parties in a care giving relationship often experience the same difficulties often resulting from similar factors, they are unable to recognize their unhappiness in the other, preventing the ability to improve the relationship by imparting these emotions. Instead, this growing cycle of negativity, eclipses the love, attachment, and shared history that exists.

Causes of Problems Within the Care Giver Relationship

While much research to date on this topic is anecdotal, it appears that one of the main causes of caregiver burnout, and rebound resentment in the one receiving care is the deliberate numbing of feelings. This is generally viewed as an attempt by both individuals to avoid pain or distress, by closing off their emotions from each other.

In care giving relationships involving seniors, especially if they also have a debilitating illness or disability, there will be stress, difficult days, and unpredictable problems. When individuals knowingly or more often unknowingly, shut each other out, and refuse to relate except around care taking tasks, this often turns into interactions characterized by mutual criticism, belittling, accusations, and sometimes aggression.

It can be difficult for someone to see how they contribute to a problematic relationship, if they only perceive how the other individual is unfair and hurtful. Each person believes they have been wronged, and eventually one feels the need to stand up for themselves, lashing out at the other. The other individual will commonly then retaliate, setting up an escalating cycle of harmful interactions that can result, in extreme cases in abuse or neglect. When isolated as individuals in care giving situations often are it is even easier for them to become blind to the other’s point of view.

Recreating the Loving Relationship

Developing the ability to see each other as equals within the family framework, and recognizing and acknowledging each other’s strengths, can help re-establish a normal, mutually caring relationship. This can help re-institute feelings of security, comfort, and trust, which neither may have consciously realized were missing. Once trust has been restored, it is possible to begin having open discussions of how each individual perceives the situation as well as how they feel their role has been defined and how they’d prefer it is defined in the future.

This process of sharing thoughts and feelings can help each person better understand the other, helping them to develop a different way to view and react to the stress of the situation instead of blaming each other. This will ultimately lead to a growing cycle of positive communication and interactions.

Sometimes, people have been socialized to believe that the need to discuss problems and feelings means that something is wrong, weak or lacking in them, and in such cases, they may need help in overcoming these roadblocks. This help can come from a number of avenues such as friends, other family members, community, support groups, clergy, or counseling. While at first, it may feel uncomfortable sharing problems with others, most come to believe the benefits of rebuilding a positive, loving relationship among family members or potentially developing a connection that is even stronger than before is worth the initial discomfort.

The continued growth of such a relationship can help each individual to see the other for who they truly are, a complete person not someone exclusively defined by the position of caretaker or care recipient. Forming an appreciation and respect for the meaningful, significant, “human” aspects of each other, will lead to the discovery of the wealth of wonderful qualities that exist within both individuals.

Concluding Thoughts

Though these steps will not entirely get rid of the very real stress involved in care taking relationships, this growing connection will provide a new found ability to better deal with the negative effects of stress in a healthier, more positive manner. While it may seem hard to change long existing ways of thinking and acting, over time, with continued effort, it will begin to feel more natural.

This can only happen, however, if those in care giving relationships are committed to building enduring relationships by working to make each other feel valued, listened to, understood, respected, cared about, and, most importantly, appreciated as someone with something important to contribute inside and outside the care giving relationship.

The Psychosocial Effects of Surrogacy

iStock_000002245637Large2An increasing number of couples are turning to the option of surrogacy to achieve their dream of having a family. Although this method continues to be controversial, there are many happy families that have expressed unqualified support for the use of surrogacy. Yet while many happy outcomes have resulted, there are psychosocial effects of surrogacy on both the biological and surrogate parents.

The Psychological Effects of Deciding to Use a Surrogate

Many couples struggle with infertility, finding that the associated distress eventually affects all aspects of their lives. Yet the decision of how to pursue the goal of parenthood is profoundly personal. Thus, many physicians have a counselor who specializes in reproductive issues available for couples who want to take advantage of this resource.

With some exceptions, couples generally attempt alternate methods to surrogacy first. This is often due to strong negative emotional responses when thinking about including another individual in the birth process. In addition, fears regarding whether the surrogate will change her mind about giving up the child can create anxiety leading to hesitancy similar to that found in couples considering adoption.

Couples may choose surrogacy due to opposition to some assisted reproduction methods especially those that greatly increases the chance of a multiple pregnancy. Often couples are required to sign a document stating they will agree to undergo selective fetal reduction, eliminating a certain number of fetuses at 11-12 weeks of gestation. Couples may find this practice unacceptable for religious or personal reasons or change their minds after becoming pregnant, which can interfere with a positive patient/physician relationship.

Couples may also choose surrogacy after learning they will not be able to adopt due to either not meeting required age limitations or reluctance to place a child with a single parent or a homosexual couple. In addition, when using an agency, the waiting time can be extremely lengthy. Some of these families initially lose hope and go through a grieving process but eventually begin to consider other options and feel the return of optimism about the potential of establishing a family.

Medical reasons may also create a situation where surrogacy is recommended. When the probability of successful implantation or gestation is low, physicians often suggest the possibility of surrogacy. This is often an option couples never thought of using and they frequently experience a sense of shock when learning this process is their only option. They may also feel confusion over the desire to have a child and initial reluctance to use a surrogate.

Psychological Reactions to the Type of Surrogacy Utilized

There are two types of surrogacy. In traditional surrogacy, the birth mother is inseminated with the sperm of the father, such that the surrogates egg is used. This method may be chosen due to the mother lacking viable eggs or the couple being unable to afford IVF, as intrauterine insemination is considerably less expensive. This type of surrogacy may require the couple to adopt the child after birth.

This can result in emotional difficulties especially for the adoptive mother given that her husband will be the biological father and another woman will be the biological mother creating resentment. These future mothers then feel guilty since they agreed to the process and feel they should be grateful to the surrogate. They may then enter a stage of self- blame since the reason they aren’t the biological mothers is because of a perceived defect within their bodies and this can lead to depression and negative self –concept. Ideally, when the pre-procedure evaluation identifies possible emotional problems before, during and after implantation occurs it is recommended that supportive counseling be started prior to the beginning of the medical process and continue during the pregnancy and after the birth.

It’s not only the mother who experiences these emotions. Fathers often feel guilty that they are the only biological parent, knowing that this is negatively affecting their wives or partners. They also may experience guilt over feeling happy that they are the biological father. Couples often find it impossible to discuss these types of issues, underscoring the need for appropriate intervention to help the couple talk about their feelings and learn how to better support each other.

In gestational surrogacy, the couples sperm and egg are fertilized and transferred into the surrogate through IVF. In most states, the intended mother is allowed to put her name on the birth certificate after birth. There are far fewer negative psychological effects when using this type of surrogacy though the anxiety, jealousy and resentment related to another woman carrying their child can surface.

Effects on the Surrogate

There has also been concerns raised over the impact of the process on the surrogate. Many surrogates report experiencing negative reactions from those around them and some report negative effects on their relationship with their spouse and children. However, research suggests that surrogate mothers feel positively about their decision to act as a surrogate. Although some experience problems giving up the baby, these difficulties were not severe and dissipated quickly.

In one study, after giving up the baby, 35 percent of the surrogates experienced mild to moderate problems within the following two weeks, 15 percent reported problems three months afterwards, while only 6 percent reported problems one year afterward. Prior to the birth 9 percent of the surrogates experienced psychological problems, 6 percent consulted a general practitioner for help, and 3% had regular appointments at an outpatient clinic.

Research also demonstrated that there was a significantly higher number of known surrogates (e.g. mothers, sisters, friends), who experienced problems after giving up the baby when compared to unknown surrogates.

Few surrogates experienced conflicts with the commissioning couples and there was no difference in the reactions of known surrogates to unknown surrogates. All surrogates reported either positive or neutral reactions in their children. However, there was a mixed reaction from partners. At the time the women decided to become surrogate mothers, 57 percent of partners responded positively, 24 percent responded neutrally/ambivalently and 19 responded negatively. 12 percent of the surrogates reported the arrangement had resulted in a poorer relationship with their partners, while 3% reported very severe relationship problems.

Conclusions

While surrogacy arrangements can result in psychological difficulties for the both members of the commissioning couple, overall most parents report that while the decision to use a surrogate had been difficult that they had experienced little anxiety or other psychological difficulties during or after the pregnancy.

Similarly, while some surrogates and their partners experienced difficulties during the pregnancy and after handing over the child, for most the experience appears to be positive and most difficulties dissipate within a year after giving up the baby.

Commissioning couples and surrogates generally report positive relationships with each other during and after the birth and transfer of the baby. They also report maintaining contact and the intention to maintain contact throughout the child’s life.

Yet it’s important to keep in mind that there are those who do have psychological difficulties and it is important that there is a method in place during evaluations conducted throughout the process to assess such factors. If problems are discovered, encouraging supportive counseling is a crucial step in helping all participants perceive the surrogacy process as a positive experience.

Increase Your Luck and Achieve Your Goals

Using Life’s Unpredictable Moments to Increase Your Luck and Achieve Your Goals

27130EDURGB1Susan wanted to attend graduate school in psychology but as a single mother, lacked the money to pay. She worked several jobs when her mother could stay with the baby save some money monthly towards school. She was certain she’d earn her degree when the time was right.

One afternoon, stuck in traffic, Susan stopped in front of a local University she had considered attending until learning they had no psychology graduate program. She noticed a new building with a sign in front that she read with increasing excitement. The building housed the school’s new psychology graduate program. Without thinking about it, she turned into the campus

While looking around a woman approached Susan, introducing herself as the Graduate Studies Director Susan discussed her aspirations. Susan explained why she hadn’t yet been able to fulfill her goal The Director was impressed with Susan’s drive, attitude and determination to obtain her degree. Seeking strong students for the new program, startup funds were available for full scholarships. Before Susan left, she’d completed the application, called three individuals for references, and ordered her transcript On the way out, the Director showed her the free campus daycare. Susan now teaches at the University that helped her fulfill her dream, while her 6 year old daughter attends the campus free kindergarten.

Was Susan simply lucky? She wouldn’t have learned about the program and opportunities had she not investigated, despite lacking the funds to attend graduate school. Always keeping an open mind, Susan looked into every possibility, even those that seemed impossible, believing anything could happen if you attended to every potential opportunity that came your way.

Our perceptions of what is possible influence our thoughts, which influence our emotions and actions. Those who perceive the world as a place where anything is attainable, fill their minds with thoughts of a positive future, feel confident and secure, and are satisfied with their current reality. They quickly forget what doesn’t work out and look for the next opportunity. Individuals with these characteristics have been shown to be happier and more likely to fulfill their dreams than those who wait for chance to change their lives.

Characteristics Common to Lucky People

Most people define luck as something dependent on chance or fate, something over which they have no control. Yet those who believe they can make their own luck have certain personality characteristics that have been shown to predict the number of ideal opportunities a person encounters over time. These individuals have personality styles defined by enthusiasm, creativity, flexibility, excitement over new opportunities, preference for novelty, good people skills and possessing a wide variety of interests and skills.

Individuals with this personality style see life as a gift and take advantage of each prospect they perceive Their eagerness, passion and potential inspire others and they are skillful at using their social skills to help them reach their goals. They live according to their inner values which helps direct their intuition which they feel comfortable acting upon. Their wide range of interests aids in the development of numerous skills. These characteristics predispose individuals with this personality style to perceive opportunities, determine how best to take advantage of them, and convince others they are capable of achieving whatever is expected with their unique skill set.

Adjust your traits, Improve Your Luck

While personality is thought to be predetermined there are ways to develop some of the traits characteristic of those perceived as lucky.

Open mindedness is the primary factor that allows individuals to explore new ways of thinking and behaving to achieve a lucky lifestyle When changing habits there’s a learning curve which includes failure especially in the beginning. Thus, having others who support you and are positive about your new perspective on life will help you retain your optimism.

When you have a strong support network in place try to adopt new characteristics. Beginning with your perceptions, work on viewing each unexpected situation as a possibility for reaching your goal. Think in a creative manner to generate as many strategies for taking advantage of the situation Tap into your creativity to explore new interests and develop new skills Maintain optimistic thoughts and try to view failure as moving you one step closer toward your goal. Expand you social network and establish connections with as many people as possible since this will increase the likelihood of meeting someone who offers you an opportunity leading to the fulfillment of you goal.

At first these strategies may seem difficult depending on your personality style However, the more you practice these patterns, the easier they will become until they are automatic It will become natural for you to perceive your world optimistically, think in ways that reinforce the idea that every opportunity has the potential for growth. This new world view will likely result in improved mood and changes in your behavior such that you are more spontaneous when faced with unexpected situations or when meeting new people.

When you begin to work on establishing this life plan and strive to improve in each area, over time the different aspects will become integrated into your natural personality style. One day you will suddenly realize you are living a lucky life. The ability to increase your luck is possible if you’re willing to alter your perceptions, thoughts and behaviors and use the state of your emotions as cues to your success, While some may have this “lucky” personality, few fully take advantage of these characteristics to improve their overall quality of life. Yet, if you leave your life course to chance alone, you are likely to find luck elusive.

Mass Killings as a Social Phenomenon – The Importance of Social Connections for Mental Health

handgunWe all watched in horror as the details of what took place at Sandy Hook Elementary School unfolded. We saw small children rush into the arms of their crying parents and cried with the parents whose children would not be returning to them.

While this shooting touched us deeply due to the young age of most of the victims, this is far from the only mass killing that has occurred recently. In 2012, there were at least 16 other mass shootings in the U.S. where the victims were chosen randomly. Although some criminologists may disagree, it appears that mass killings are increasing in this country. The response to Sandy Hook has largely focused on gun control legislation, yet examining the backgrounds of the shooters may prove more effective in preventing these types of killings.

Changing Focus

Researchers have begun examining characteristics of these perpetrators to identify potential background factors associated with their later behavior. Currently under scrutiny is the breakdown of community connections within our society. Personal interactions have lessened with the wide spread use of mobile technology to communicate, shown to lead to greater social isolation. Certain individuals are more vulnerable to the negative effects of social rejection as it effects their ability to cope with stress. This process however, must be addressed in childhood.

Social Learning

When faced with stressful situations, we all have different ways of coping. We may take a long bath, distract ourselves with a book, call a friend or exercise. The key is to regulate our emotions through previously successful methods.

When faced with stress, those without appropriate coping strategies or social support may respond with aggression resulting from excessive negative emotionality. This underscores the importance of social learning in developing the ability to cope with stress adaptively.

We begin to learn appropriate responses to stress from imitating others. Family members may also suggest options to help us cope when we’re agitated. As we age friends help us cope with stress by listening, validating our reactions and supporting us. From such interactions we learn the value of relying on trusted others to cope with what we perceive as unfair.

Humans are social beings and we look to others to determine how to solve problems or deal with negative emotions. When friendships begin to form we develop empathy and perspective taking skills, such that we perceive when those we care about are suffering and try to help while they do the same for us. Meaningful relationships are critical when faced with stress

JPPositive and Negative Social Learning

Children learn adaptive coping skills from knowledgeable adults in their lives who recognize signs of stress and excessive emotionality. These adults teach children to identify feelings of stress and help them learn to modulate their emotions adaptively. Adults may also model this behavior, reinforcing the learning process.

Sometimes however, children lack positive role models from whom to gain these skills and never learn to recognize their feelings or cope well with stress. They lose control of their emotions and act out causing others to avoid them. This lack of acceptance can confuse children who can’t differentiate their behavior from that of their peers. These children often become isolated, and they aren’t exposed to the social feedback necessary to learn social skills.

Detachment grows as they try to teach themselves not to care about being accepted. However, since all children crave acceptance they will intermittently attempt to interact. With no new skills to use however, peers continue to reject them and they respond by increased aggression.

These children often come from homes where adults are frequently absent or if present, model negative coping such as responding to problems with violence. This reinforces children’s emotional dysregulation. Often also rejected by other adults such as teachers, these children are unlikely to get the help they need resulting in a pattern of responding to stress with aggression in adulthood.

Helping Children Reduce Stress and Cope Adaptively

Anecdotal research indicates that negative situations experienced by children who become mass killers weren’t recognized or validated, and they never learned to cope adaptively with stress. Some techniques to help children learn to deal with life problems include:

Acknowledgement-Acknowledging children’s feelings, first attending more to the children’s experiences and less to the resulting behavior can establish the sense that adults are listening. Dismissing children’s experiences and emotions sends the message that adults don’t believe their experiences are important, blocking future trust and openness.

Once children believe adults understand them, they can be taught how to use adaptive coping strategies to deal with negative emotions resulting from stress. After they can modulate their emotions, they are ready to learn problem solving skills for different stressful situations. These new skills can provide the basis for teaching social skills to help children reintegrate into their peer group.

Noticing the Positive-Socially isolated children generalize their sense of failure to every aspect of their lives. Thus, it’s important to notice and praise children for the good things they do to lessen their sense of defeat and lack of confidence.

Providing Appropriate Modeling-Adults need to model the same strategies they are teaching children for coping with stress. This is especially important for interpersonal problems such as family disputes, arguments with friends, or interpersonal problems at work. If a problem can’t be solved, coping with the negative emotions associated with the situation can be modeled.

Numerous studies have demonstrated the importance of social support in creating resilient adults. The harmful effects of poor social support and protective effects of positive support on mental health are firmly established. As a number of mass shooters have been determined to suffer from mental illness, learning how to create a positive social network from a young age can be a critical factor in preventing later disaster.

Health Care Delivery System Provision of Preventive Behavioral Services

The need for behavioral services is substantial. Many who could benefit from treatment for these disorders do not receive care (Woodward et al., 1997; Harwood, Sullivan, & Malhorta, 2001).

Some of the lack of development of behavioral health services within health care delivery systems may be owing to the perception that mental health and substance use disorder services may be “softer” and therefore less effective than conventional medical therapy. However, the efficacy and cost-efficiency of these services is well established and has been recommended by multiple national organizations since at least the early 1990s (U.S. Preventive Services Task Force [USPSTF], 1996, 2002a, 2003).

The 1994 IOM report was titled Reducing Risks for Mental Disorders—Frontiers for Preventive Intervention Research (Mrazek & Haggerty, eds., 1994). A 1998 follow-up report, Preventing Mental Health and Substance Abuse Problems in Managed Care Settings (Mrazek, 1998), was completed in collaboration with the National Mental Health Association (NMHA). This report recommended widespread implementation of primary preventive programming to address five problem areas within health care systems:

  1. Prevention of initial onset of unipolar major depression across the life span
  2. Prevention of low birthweight and prevention of child maltreatment in children from birth to 2 years of age whose mothers are identified as being at high risk
  3. Prevention of alcohol or drug abuse in children who have an alcohol- or drug- abusing parent
  4. Prevention of mental health problems in physically ill patients (comorbidity prevention)
  5. Prevention of conduct disorders in young children

The 1999 Surgeon General Report was titled Mental Health: A Report of the Surgeon General (DHHS, 1999). Although the major focus of this report was care and management of mental disorders, all major preventive services were included.

SAMHSA published two recent prevention-related health care reports. The 2000 literature review titled Preventive Interventions Under Managed Care (Dorfman, 2000) used broader definitions of “prevention” and “mental health services” and recommended six interventions for managed care plans:

  1. Prenatal and infancy home visits
  2. Targeted cessation education and counseling for smokers—especially those who are pregnant
  3. Targeted short-term mental health therapy
  4. Self-care education for adults
  5. Presurgical educational intervention with adults
  6. Brief counseling and advice to reduce alcohol use

This new literature review retains four of the above services and omits numbers three and four on short-term mental health therapy and self-care. The companion document published in 2002 was titled Estimating the Cost of Preventive Services in Mental Health and Substance Abuse Under Managed Care (Broskowski & Smith, 2002). This report provided cost data for each of the services recommended in the 2000 literature review.

It also featured, for each set of recommended services, a range of costs and options based on case mix and private versus public insurance coverage. It estimated the cost to managed care organizations (MCOs) to implement recommendations for four possible scenarios ranging from most expensive to least expensive, given drivers such as enrollment mix, staffing, staff salaries, and fixed and variable expenses. This report did not consider savings in other health care expenses. Even with the most expensive of cost profiles, the report did conclude that all six services could be fully implemented at a marginal cost of less than a 1 percent increase in cost, per member per month.

During this period, SAMHSA and the National Committee on Quality Assurance (NCQA)–sponsored Health Employer Data Information Set (HEDIS) program have attempted to bring preventive behavioral services to the attention of the managed care community. In response to market pressures to demonstrate high scores on HEDIS measures, the managed care community has taken giant strides to improve the care of patients with depression and has taken steps to enhance member adherence to prescribed regimens of care for diabetes.

In 1998, SAMHSA’s Center for Substance Abuse Prevention created the National Registry of Effective Programs (NREP) as a resource to help professionals in the field become better consumers of prevention programs (Schinke et al., 2002). NREP reviews and screens evidence-based programs (conceptually sound and/or theoretically driven by risk and protective factors) that, through an expert consensus review of research, demonstrate scientifically defensible evidence. NREP initially focused on substance use prevention but has expanded to include mental health; co-occurring mental health and substance use disorders; adolescent substance use treatment; mental health promotion; and adult mental health treatment. Many programs focus on school and family, but increasingly, programs from community coalitions and environmental programs are being identified as well implemented, well evaluated, and effective.

NREP evaluates programs for substance abuse prevention and treatment, co-occuring disorders, and mental health treatment, promotion, and prevention. After receiving published and unpublished program materials from candidates, NREP reviewers, drawn from 80 experts in relevant fields, rate each program according to 18 criteria for methodological rigor, and they also score programs for adoptability and usefulness to communities (Schinke et al., 2002). Based on the overall scoring, NREP categorizes programs as Model Programs, Effective Programs, Promising Programs, or Programs with Insufficient Current Support. Those wishing to learn more about Model Programs can visit www.modelprograms.samhsa.gov. At this site, there is also a link providing detailed information about NREP and the process for submitting a program for NREP review.

Despite these efforts, behavioral services— both preventive and therapeutic—still are not adequately identified, provided, or arranged by primary care practitioners. They also are not adequately promoted by health care systems. Brief screening instruments for alcohol and drug problems, for example, have been available for a number of years but are not widely used by practicing physicians (Duszynski, Nieto, & Vanente, 1995; National Center on Addiction and Substance Abuse at Columbia University, 2000). In a 2002 review, Garnick et al. (2002) conducted a telephone survey covering 434 MCOs in 60 market areas nationwide and secured useful responses from 92 percent of them. Only 14.9 percent of MCOs required any alcohol, drug, or mental health screening by primary care practitioners. Slightly more than half distributed practice guidelines that addressed mental illness, and approximately one third distributed substance use disorder practice guidelines.

DHHS’s 2003 campaign, Steps to a Healthier U.S., focuses on chronic disease prevention and health promotion with the goals of decreasing both the prevalence of certain chronic diseases and the risk factors that allow conditions to develop. This initiative aims to bring together local coalitions to establish model programs and policies that foster health behavior changes, encourage healthier lifestyle choices, and reduce disparities in health care.

In early 2003, SAMHSA published a review of the delivery of behavioral services by managed care organizations, based on 1999 data. This report, The Provision of Mental Health Services in Managed Care Organizations (Horgan et al., 2003), showed substantial variability from plan to plan, as well as substantial variability among health maintenance organizations (HMOs), point- of-service (POS) plans, and preferred provider organizations (PPOs). All MCOs provided behavioral services, but these services usually had limits and copayments that were more restrictive than for comparable medical services. Fewer than 10 percent required screening for behavioral disorders in primary care settings (Horgan et al., 2003).

Another SAMHSA report, also published early in 2003, offers some insight into discrepancies in coverage, comparing medical to behavioral services and discrepancies in policy and coverage, comparing therapeutic to preventive services. This report, titled Medical Necessity in Private Health Plans: Implications for Behavioral Health Care (Rosenbaum, Kamoie, Mauery, & Walitt, 2003), noted that services are covered by health insurance plans only if they are considered a “medical necessity.” The term medical necessity was defined differently for different services within each health plan, with due consideration given for each of the following five domains:

  1. Contractual scope—whether the contract provides any coverage for certain procedures and treatments, such as preventive and maintenance treatments that are not necessary to restore a patient to “normal functioning.” This dimension preempts any other coverage decision.
  2. Standards of practice—whether the treatment (as judged by the health plan) accords with professional standards of practice.
  3. Patient safety and setting—whether the treatment will be delivered in the safest and least intrusive manner.
  4. Medical service—whether the treatment is considered medical as opposed to social or nonmedical.
  5. Cost—whether the treatment is considered cost-effective by the insurer (Rosenbaum et al., 2003).The medical necessity report noted that

Federal or State regulation is limited in covering how health insurance plans define medical necessity (Rosenbaum et al., 2003). This SAMHSA update is intended to build upon the reports noted above to further enhance implementation of preventive behavioral services in health care settings.

Clinical vs. Community Preventive Services in Mental Health

Most preventive behavioral services are delivered in school and community settings, not health care settings (Schinke, Brounstein, & Gardner, 2002; DHHS, 1999). In a 1998 review of indicated preventive behavioral services for children and adolescents, Durlak and Wells (1997) used meta-analysis to review 177 programs—73 percent were in a school setting, compared with 23 percent that were mainly in medical settings. In a similar review published 1 year later by the same authors (Durlak & Wells, 1998), none of the programs was in a medical setting.

This report has been prepared to summarize and analyze the most promising preventive interventions (based on rigorous research studies) for consideration by health care organizations. Only interventions deliverable by health care systems are reviewed in this report. Most community preventive services are oriented toward school-age children, adolescents, and young adults—age groups with relatively low exposure to health care delivery settings. Such services generally are provided by and through schools and community organizations.

Health care settings, however, are effective in reaching pregnant women, infants, adults with major chronic medical illnesses, and those in need of surgical procedures. For example, these settings provide a place to address the behavioral needs of these patients through behavioral screening and preventive services, with follow-up in prescribed regimens of care. In this way, clinical preventive services for depression and substance abuse can reduce emergency room use and hospitalization (Olfson, Sing, & Schlesinger, 1999). Psychoeducational services also can speed recovery of postsurgical patients (Egbert, Battit, Welch, & Bartlett, 1964; Mumford, Schlesinger, & Glass, 1982).

It may not be incumbent upon health care delivery systems to provide highly specialized social and educational support services (Devine, O’Connor, Cook, Wenk, & Curtin, 1988), but health care delivery systems do have a role to play. Through their mental health and social work staff, they maintain working relationships with community- based, social service, educational, and even correctional agencies to ensure they meet the needs of members of the health care delivery system.

Vilazodone (Viibryd)

Vilazodone, a new oral antidepressant, received FDA-approval on January 21, 2011 with a labeled indication for the treatment of major depressive disorder (MDD) in adults.

The purpose of this monograph is to (1) evaluate the available evidence of safety, tolerability, efficacy, cost, and other pharmaceutical issues that would be relevant to evaluating vilazodone for possible addition to the VA National Formulary; (2) define its role in therapy; and (3) identify parameters for its rational use in the VA.

Pharmacology

The mechanism of action of vilazodone is inhibition of reuptake of serotonin and partial agonism at 5HT1a receptors. The antidepressant effect is thought to be due to vilazodone’s SSRI quality. It is unknown if the partial agonism of 5HT1a receptors by vilazodone produces any beneficial effect. It has been hypothesized that vilazodone has a faster onset, compared to SSRI’s alone, as the additional partial agonism of the 5HT1a receptor results in a more rapid and specific desensitization of the somatodendritic 5HT1a autoreceptors. Chronic administration of a SSRI results in desensitization of presynaptic 5HT1a autoreceptors.

The median time to maximum plasma concentration is 4 to 5 hours. At steady state and under fed conditions, the mean plasma concentration was observed to be 156 ng/mL, and the mean area under the curve (AUC) was 1645 ng•h/mL. Vilazodone’s bioavailability is 72% when taken with food.

Vilazodone demonstrates dose-proportional pharmacokinetics. Steady state is reached after 3 days of dosing. Vilazodone primarily undergoes hepatic metabolism and the terminal half-life is approximately 25 hours.

FDA Approved Indication(s)

FDA labeled indications:  Treatment of major depressive disorder in adults.

Potential off-label uses: Other antidepressants have label indications for or are used off-label to treat anxiety disorders, bipolar depression, PTSD, chronic pain, and vasomotor symptoms.  Results of a search of PubMed and clinical trials.gov found vilazodone has been studied only as a treatment for MDD.

Current VA National Formulary Alternatives
Other antidepressants on the VANF include SSRIs (citalopram, fluoxetine, sertraline, paroxetine); tricyclic antidepressants (TCAs); venlafaxine; bupropion; mirtazapine; trazodone; and monoamine oxidase inhibitors (MAOIs).  Only MAOIs are restricted to mental health providers with criteria for use.

Dosage and Administration

Initiation of treatment
The recommended dose for vilazodone is 40 mg once daily.  When starting vilazodone, the drug must be titrated. Start at 10 mg once daily for 7 days, followed by 20 mg once daily for an additional 7 days, and then increased to 40 mg once daily. The maximum daily dose is 40 mg/day.

Dose adjustment in patients with impaired kidney function
No dosage adjustment is recommended in mild, moderate, or severe renal impairment.

Dose adjustment in hepatic impairment
Mild-to-moderate impairment: No dosage adjustment is recommended.
Severe hepatic impairment: Vilazodone has not been studied in severe hepatic impairment.

Dose adjustment in the elderly
No dose adjustment is recommended on the basis of age.

Administration

Vilazodone should be taken with food. Administration without food may decrease drug concentrations by approximately 50% and may diminish effectiveness. There are no specific recommendations regarding timing of administration as long as the drug is taken with food.
The dose of vilazodone should be reduced to 20 mg if co-administered with a strong inhibitor of CYP3A4. Consider decreasing vilazodone dose to 20 mg if co-administered with a moderate inhibitor of CYP3A4 and side effects are intolerable.

Discontinuation of treatment
Withdrawal symptoms have been reported with discontinuation of sertonergic drugs like vilazodone. Gradual dose reduction is recommended to prevent withdrawal symptoms.

Efficacy

Efficacy Measures
Major Depressive Disorder:
Montgomery-Asberg Depression Rating Scale (MADRS): A clinician rated 10-item scale that assesses mood, anxiety, appetite, sleep, functional status, ability to think and general psychiatric distress.
Hamilton Depression Rating Scale (HAM-D-17): A clinician-rated 17-item checklist, ranked on a 0–4 or 0–2 scale that assesses the severity of depressive symptoms in patients with primary depressive illness and monitoring changes with treatment.
Clinical Global Impression (CGI) Scale: Clinician-rated scale globally assessing response to medication treatment. Scales measure improvement (CGI-I) and severity of illness (CGI-S).

Safety Measures

Sexual Dysfunction:
Changes in Sexual Functioning Questionnaire (CSFQ): A questionnaire (36 items for men and 35 items for women) that measures disease- and medication-related changes in sexual functioning by evaluating current and lifetime sexual functioning.
Arizona Sexual Experience Scale (ASEX): A 5-item scale (range 5 to 30) used to assess sexual dysfunction.

Deaths and Other Serious Adverse Events
Khan and colleagues reported 5 serious adverse events (angina pectoris, carotid arteriosclerosis, chest pain, cholecystitis, and pneumonia). Rickels and associates reported 6 adverse events occurring in 5 patients (one occurrence of the following: lymphadenopathy, concussion, prostate cancer, suicide attempt; two occurrences of depression). Robinson and colleagues reported 33 serious adverse events occurring in 23 patients (3.8%), most of which were judged as not related to vilazodone; 8 patients had adverse events of either suicidal ideation or behavior. No deaths occurred in these studies.

Common Adverse Events

Rickels, et al. reported that 19 (9.3%) patients in the vilazodone group and 10 (4.9%) patients in the placebo group discontinued treatment due to adverse events. Adverse events occurred in 164 (80%) patients in the vilazodone group and 130 (63.7%) patients in the placebo group. Sexual dysfunction was evaluated using the ASEX scale. The mean ASEX scores at baseline among men were 15.8 and 16.5 in the placebo and vilazodone groups, respectively, and, among women, the mean baseline ASEX score was 21.2 in both treatment groups. The change from baseline to week 8 was -0.4 to -1.3 for both sexes in both treatment groups indicating slight improvement.

Kahn et al. reported that 12 patients on vilazodone (5.1%) versus 4 (1.7%) on placebo discontinued treatment due to adverse events. See table 10 for types of adverse events. Sexual dysfunction was evaluated using the CSFQ questionnaire. The mean CSFQ scores at baseline among men were 46.5 and 46.6 in the vilazodone and placebo groups, respectively, and, among women, the mean baseline CSFQ scores were 39.4 and 40.2 in the vilazodone and placebo groups, respectively. Improvement in CSFQ score was observed for both sexes and for both treatment groups (vilazodone versus placebo, CSFQ improved by 0.6 and 1.8 points for men, respectively, and 1.9 and 2.3 points for women, respectively). However, sexual dysfunction adverse events as a whole were more frequent in the vilazodone group, occurring in 21 patients compared to only 1 patient in the placebo group. Decreased libido was the most frequent type of sexual dysfunction reported occurring in 11 vilazodone patients (4.7%) and in no placebo patients.

Tolerability

In the Khan and colleagues study, a similar number of patients in each group, 19.6% in the vilazodone group and 19.1% in the placebo group, discontinued treatment prematurely (Table 13).  Of those who completed the study, 12 vilazodone patients (5.1%) versus 4 placebo patients (1.7%) discontinued treatment due to adverse events; gastrointestinal events led to treatment discontinuation in 4 vilazodone patients (2 nausea, 1 vomiting, and 1 dyspepsia) and none in the placebo group.

In the Rickels and associates study, a similar number of patients in each group, 25.9% in the vilazodone group and 24.9% in the placebo group, discontinued treatment prematurely (Table 13). Of those who completed the study, 19 vilazodone patients (9.3%) versus 10 placebo patients (4.9%) discontinued treatment due to adverse effects.

Contraindications

Do not use vilazodone concomitantly with a MAOI or within 14 days of stopping or starting a MAOI.

Warnings and Precautions

Boxed Warning: Increased risk of suicidal thinking and behavior in children, adolescents, and young adults (18 – 24 years) taking antidepressants for MDD and/or other psychiatric disorders.
Worsening of depression, emergence of suicidal thoughts and/or behavior.
Development of serotonin syndrome during treatment with vilazodone alone or in combination with other serotonergic drugs such as other antidepressants and triptans.
Abnormal bleeding.  Concurrent use with other drugs that affect clotting or increase the risk of bleeding, e.g., NSAIDS, should be used with caution and patients informed of the increased risk and how to respond.
Activation of mania or hypomania.
Discontinuation symptoms after stopping serotonergic antidepressants either abruptly or during dose reduction have been reported.
Hyponatremia has been reported as a result of treatment with SSRIs and SNRIs. Syndrome of inappropriate antidiuretic hormone secretion (SIADH) appears to be the cause.

Use in Pregnancy

Vilazodone caused some developmental toxicity in rats, but was not teratogenic in rats or rabbits.
Third trimester exposure of SSRIs have resulted in prolonged hospitalization, respiratory support, and tube feeding for the neonate.  There are no adequate and well-controlled studies of vilazodone in pregnant women so careful consideration should be made when determining if the potential benefits outweigh the potential risks of treatment in pregnant women.

Use in Breast Feeding – Vilazodone is excreted into the milk of lactating rats. It is unknown as to whether vilazodone is excreted into human breast milk.

Drug Interactions

Drug-Drug Interactions
As with all antidepressants concomitant use with MAOIs is to be avoided.
Concurrent use with NSAIDs may increase the risk of gastrointestinal bleeding or bleeding in general.
Prolonged bleeding times may occur when used with anticoagulants such as warfarin.
Concomitant use with potent CYP3A4 inhibitors may increase vilazodone’s concentrations. Administration of a strong CYP3A4 inhibitor may increase vilazodone’s plasma concentrations by approximately 50%.
Drugs that induce CYP3A4 may reduce vilazodone systemic exposure, however, the effect on plasma concentrations has not been evaluated.
Drugs which inhibit other CYP isozymes are not expected to significantly alter vilazodone’s pharmacokinetics.
Vilazodone is highly bound to protein plasma and may increase the free concentrations of other highly protein bound drugs.

Mental Health Models of Preventive Services

Models of Preventive Services

Two well-known models of preventive services are used when referring to behavioral programming for public health or mental health promotion and substance use prevention. They are reviewed briefly here.

The Public Health Model

Public health traditionally defines preventive services as “primary,” “secondary,” or “tertiary.”

Primary preventive services, such as immunizations and programs related to tobacco, diet, and exercise, are intended to intervene before the onset of illness to prevent biologic onset of illness.

Secondary preventive services include screening to detect disease before it becomes symptomatic, coupled with follow-up to arrest or eliminate the disease. The Pap test and mammography are medical examples of secondary prevention.

Tertiary prevention refers to prevention of complications in persons known to be ill. Prevention of stroke through effective treatment of hypertension is an example of tertiary prevention. Much of disease management is tertiary prevention. In the public health model, the three levels of prevention are separate and distinct.

The Continuum of Health Care Model According to the Institute of Medicine (IOM)

When dealing with substance use and other behavioral disorders in clinical settings, the levels of prevention are less distinct than with physical illnesses. The tasks of identifying risk factors and detecting early- stage disease are usually accomplished by patient or family interview. Initial management of both risk and early stage disease is often conducted via patient and family counseling by the primary care provider. Thus, the continuum of the health care model is more practical than the public health model when dealing with preventive behavioral health services.

cohcFig1

The continuum of health care model is drawn from a 1994 report of the Institute of Medicine (IOM) (Mrazek & Haggerty, eds., 1994), as originally proposed by Gordon (1983). It differs from the public health model in that it covers the full range of preventive, treatment, and maintenance services. There are three types of preventive services in the IOM model—universal, selective, and indicated. These do not correspond to the primary, secondary, and tertiary services in the public health model. Screening and follow-up preventive behavioral services correspond to secondary prevention within the public health model. Other preventive behavioral services, including most community-based services, correspond to primary or tertiary prevention.

In the IOM model, a “universal” preventive measure is an intervention that is applicable to or useful for everyone in the general population, such as all enrollees in a managed care organization. A “selective” preventive measure is desirable only when an individual is a member of a subgroup with above-average risk. An “indicated” preventive measure applies to persons who are found to manifest a risk factor that puts them at high risk (Mrazek & Haggerty, eds., 1994). All these categories describe individuals who have not been diagnosed with a disease.

Universal interventions, on a per-client basis, are relatively inexpensive services offered to the entire population of a life- stage group. They are conducted as a primary prevention or screening to identify sub-populations and individuals who need more intensive screening, preventive, or therapeutic services. A clinical example would be the provision of prenatal care as a universal service for all pregnant women. A behavioral health example would be the use of a simple screening protocol to identify depression in all adult patients at all primary care visits.

Selective interventions are more intensive services offered to subpopulations identified as having more risk factors than the general population, based on their age, gender, genetic history, condition, or situation. For example, more intensive breast cancer screening is provided for women with a family history of breast cancer. A behavioral health example would be offering smoking cessation programming to all smokers.

Indicated interventions are based on higher probability of developing a disease. They provide an intensive level of service to persons at extremely high risk or who already show asymptomatic, clinical, or demonstrable abnormality, but do not meet diagnostic criteria levels yet. Case management and intensive in-home assessment, health education, and counseling are examples of indicated interventions (Mrazek & Haggerty, eds., 1994).

Sometimes a universal service is a screening procedure provided to all, or a primary prevention procedure such as vaccinations for children. The selective service involves diagnostic procedures to confirm or deny a diagnosis, and the indicated service involves much more intensive, individualized services for those at highest risk.

The efficacy and cost-efficiency of preventive services depend on the entire array of universal, selective, and indicated service components. They also depend on the ability of the health care system to target and limit the more costly indicated interventions to those who could most benefit from them.

Clinical Preventive Behavioral Services

Clinical preventive services for behavioral disorders usually start with the primary care provider taking 30 seconds to 2 minutes to screen for depression and the various substance-use topics.

This screening is followed by a diagnostic interview and counseling for those showing evidence of high-risk or early-stage behavioral illness. Then, either the primary care provider or a specialized mental health professional provides follow-up management. These interventions require skill, consistency, and special training of the primary care providers as well as the capacity of the health care delivery system to connect selected patients with specialized mental health professionals. There is little value to such screening procedures if the health care delivery system lacks the means to follow up with definitive diagnoses and management. Some health care systems opt for increased training of primary care practitioners to reduce reliance on mental health professionals.

  • Most clinical preventive services require the same infrastructure elements as those commonly used for quality assurance, accreditation, and in some States, licensure and Medicaid reimbursement:
  • Policies and procedures, with committee oversight and annual review
  • Provider training
  • Patient outreach and communications
  • Data systems—often including dummy billing codes (codes for services that are not individually reimbursed), chart review, and/or limited patient and provider surveys

These preventive services differ from those usually classified as “disease management” or “demand management” in that patients needing these preventive services usually are identified through clinical screening, not through review of the claims database.

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