Effectiveness of Family-Focused Treatment Plus Pharmacotherapy for Bipolar Disorder in Adolescents

Bipolar disorder (BPD) is a serious mental illness that causes drastic shifts in a person's
mood, energy, and ability to function. BPD 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
BPD 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 BPD symptoms in adolescents. This study will evaluate the effectiveness of
FFT plus pharmacotherapy in treating adolescents with BPD.

Participants in this 2-year, single-blind study will be randomly assigned to receive a
combination of either FFT and pharmacotherapy or enhanced care (EC) 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 EC 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 EC treatment sessions will include psychoeducation
focusing on appropriate ways to manage BPD 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 BPD symptoms, functioning, and service utilization, will be
measured at study visits at Months 3, 6, 9, 12, 18, and 24.