Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the effectiveness of family-focused treatment (FFT) plus
      pharmacotherapy in treating adolescents with bipolar disorder.
    

Detailed description: 
      Bipolar disorder is a serious mental illness that causes drastic shifts in a person's mood,
      energy, and ability to function. Bipolar disorder can strike at any age, but it most commonly
      develops in late adolescence or early adulthood. The disorder is characterized by alternating
      episodes of mania and depression, often with periods of normal mood in between. Some symptoms
      of a manic episode include the following behaviors: increased energy, activity, and
      restlessness; excessively "high," overly good, euphoric mood; and extreme irritability. In
      contrast, a depressive episode is characterized by a lasting sad, anxious, or empty mood;
      feelings of hopelessness or pessimism; and decreased energy. Adolescents with bipolar
      disorder have high rates of disease recurrence, suicide attempts, functional impairment, and
      mental health service utilization, even with aggressive treatment with mood stabilizers and
      antipsychotic drugs. Research has suggested that FFT, a behavioral intervention consisting of
      psychoeducation, communication training, and problem solving training, may lead to
      improvements in mood symptoms in adolescents with bipolar disorder. This study will evaluate
      the effectiveness of FFT plus pharmacotherapy in treating adolescents with bipolar illness.

      Participants in this 2-year, single-blind study will be randomly assigned to receive a
      combination of either FFT and pharmacotherapy or enhanced care and pharmacotherapy.
      Medications used for the pharmacotherapy portion of the study will include mood stabilizers,
      such as lithium or divalproex sodium, and atypical antipsychotics, such as quetiapine.
      Participants will also receive anti-anxiety medications, psychostimulants, or antidepressants
      as needed. All participants will receive pharmacotherapy for the full 2 years. Participants
      assigned to enhanced care will take part in weekly brief psychoeducation sessions for 3
      weeks. Participants assigned to FFT will take part in weekly treatment sessions with their
      families for 12 weeks, biweekly for 12 weeks, monthly for 3 months, and then trimonthly until
      Month 24. Both FFT and enhanced care treatment sessions will include psychoeducation focusing
      on appropriate ways to manage bipolar disorder and its cycling nature. Crisis intervention
      sessions will also be offered to all participants on an as-needed basis for the duration of
      the study. Outcomes, including bipolar disorder symptoms, functioning, and service
      utilization, will be measured at study visits at Months 3, 6, 9, 12, 18, and 24.
    

Intervention name(s): Family-Focused Treatment Plus Pharmacotherapy; Enhanced Care Plus Pharmacotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants assigned to FFT will take part in weekly treatment sessions with their families for 12 weeks, biweekly for 12 weeks, monthly for 3 months, and then trimonthly until Month 24. Medications used for the pharmacotherapy portion of the study will include mood stabilizers, such as lithium or divalproex sodium, and atypical antipsychotics, such as quetiapine. Participants will also receive anti-anxiety medications, psychostimulants, or antidepressants as needed.; Participants assigned to Enhanced Care will take part in weekly brief psychoeducation sessions for 3 weeks. The pharmacotherapy treatment will be the same as for the FFT participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Childhood Mood Disorders; Family Treatment; Psychoeducation; Pharmacotherapy; Family Functioning; Psychosocial Intervention