Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
The specific goal of this research study is to investigate the feasibility, acceptability,
and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed
specifically to target common core processes across mood and anxiety disorders [Unified
Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)], for the treatment of
patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare
treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the
UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month
period and will be assessed monthly to track changes in mood, anxiety and emotion-related
symptoms; functional impairment; and relapse rates. Data on the acceptability of the
treatment will be gathered concurrently through monthly patient self-reported ratings of
treatment satisfaction, and by tracking rates of acceptance for randomization into the study,
number of completed sessions, and dropout rates. The study will examine: 1) whether combined
cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable
and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid
anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater
symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether
treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a
6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and
functional impairment are mediated by changes in emotion regulation skills. The broader aim
of this study is to address the need for improved treatments for bipolar disorder.