The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) is a multi-centered effectiveness research program with the stated goal of determining best-practice treatment options for all phases of bipolar disorder; mania, depression, remission, and recurrence prevention. STEP-BD sought to determine which treatments, or combinations of treatments were most effective for treating “real world" patients with bipolar disorder in community settings. It included patients with diverse psychiatric and medical co-occurring illnesses who are commonly excluded from standard narrowly focused clinical efficacy trials. Pharmacotherapy interventions were chosen from lithium, valproate, bupropion, paroxetine, lamotrigine, risperidone, inositol, and tranylcypromine. Psychotherapy interventions studied were Cognitive Behavioral Therapy, Family-Focused Therapy, and Interpersonal and Social Rhythm Therapy Pharmacotherapy is first-line treatment for acute bipolar disorder episodes. While symptom remission is a necessary but not sufficient treatment goal, in the STEP-BD cohort even optimal “best practice” pharmacotherapy did not consistently and reliably achieve and maintain remission. Approximately half the participants who were symptomatic at study entry failed to achieve complete recovery. Of those patients who did achieve total symptom remission almost half experienced recurrences within the two-year follow-up period (Am J Psychiatry 2006; 163:217–224). In response to the fact that pharmacotherapy alone was inadequate for symptom relief, and of limited efficacy in resolving many of the disabilities that “cause clinically significant distress or impairment in social, occupational or other important areas of functioning”, intensive, targeted psychotherapies were developed to treat patients with bipolar disorder and their families. These therapies significantly improve symptomatic as well as functional outcomes. Patients taking medications to treat bipolar disorder were more likely to get well faster and stay well if they received intensive psychotherapy (Arch Gen Psychiatry 2007; 64:419–427). Combining family psychotherapy with pharmacotherapy enhanced post episode symptomatic adjustment and medication adherence (Arch Gen Psychiatry. 2003; 60:904-912). Intensive psychosocial treatment as an adjunct to pharmacotherapy enhanced relationship functioning and life satisfaction, and promoted stabilization from bipolar depression (Am J Psychiatry 2007; 164:1340–1347). The family-focused treatment approach for bipolar disorder is an intensive time-limited evidence-based psychotherapy designed to treat the broader milieu within which the patient is functioning. Family-Focused Therapy (FFT) is directed at teaching patients and their families about bipolar disorder and disease management, improving communication skills, and developing problem-solving skills. STEP-BD research confirmed the efficacy of Family Focused Therapy, when used as an adjunct to pharmacotherapy, to reduce time to recovery, delay relapse/recurrence, reduce relapse rates, improve patient functioning, reduce inter-episode symptoms, improve medication compliance, and increase total time in recovery for adults and teenagers with bipolar disorder over the course of 1 to 2 years. FFT has six major objectives based on three core assumptions; an episode of bipolar disorder is a non-normative family life cycle crises, each episode produces disorganization in the family system, and family reintegration requires development of new coping strategies. The six objectives, experience integration, disease acceptance, medication compliance, symptom recognition, stress reduction, and relationship restoration are operationalized into two target variables, family environmental factors and stressful life events. Treatment involves patients and at least one family member (spouse, partner, parent, or sibling) and is divided into three phases or modules, delivered in 21 sessions (12 weekly, 6 biweekly, 3 monthly) scheduled over nine months. The first module, family psychoeducation extends over 7 sessions and focuses on recognizing early warning signs of recurrence, proactive recognition of prodromal symptoms of relapse, and developing relapse prevention plans that involve multiple family members. Patients and relatives develop a shared understanding of environmental factors that increased the patients’ vulnerability to recurrences and address barriers to medication adherence. Families are acquainted with the stress-diathesis model and the reciprocal bidirectional effects between patient (symptom) and family (system). The second treatment phase, communication enhancement training, continues over the next 7 to 10 sessions and focuses on skills for active listening, delivering positive and negative feedback, and requesting changes in other’s behaviors. The final treatment section, problem-solving training, concludes with 4 or 5 sessions aimed at developing and instituting solutions to specific family problems. NIMH recently approved funding for a new study to develop Focused Family Therapy for children ages 9-17 at high risk for developing bipolar disorder. High-risk children have some symptoms of bipolar disorder, but do not show all the symptoms required for a formal diagnosis, and have an immediate family member with bipolar disorder. The long-term goal is to reduce or delay the development of bipolar disorder in at-risk youth. Children will receive pharmacotherapy if needed to help manage symptoms, though they do not have to take medication to participate in the study. Outpatient psychiatric treatment needs to follow principles of chronic disease management, which includes medication, self-management and psychosocial strategies. Pharmacotherapy and psychotherapy treatments should be integrated into a new standard of care. Families are a neglected resource for psychiatrists and their patients. Family involvement constitutes a critical support system for individuals with a serious mental illness. Dysfunctional interpersonal family relationships deprive patients with bipolar disorder of this most important and enduring resource. By learning to “think family”—always viewing the patient in that context—we are more likely to provide the best possible psychiatric treatment. Despite this, training in family therapy is still the exception rather than the rule in psychiatry residency programs.
February 3, 2010
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