Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder
Condition: Bipolar Disorder; Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      This study will compare the effectiveness of cognitive behavioral therapy versus supportive
      psychotherapy in decreasing depression in people with bipolar disorder.
    

Detailed description: 
      Bipolar I disorder (BP-I) is a chronic debilitating disorder with recurrent depressive and/or
      manic mood episodes. Although episodes of mania are often considered the most distinguishing
      feature of bipolar disorder, recurrent episodes of depression make up the most functionally
      debilitating aspect for many individuals with BP-I. Symptoms of depressive episodes include
      depressed mood, lack of interest, decreased energy, low self-esteem, trouble sleeping, and
      change in appetite. Mood stabilizers are usually the first line of treatment for patients
      with bipolar disorder who are in a depressive episode, but previous research has shown that
      these treatments fail to bring most patients to sustained remission. As an adjunct to
      medication, a psychosocial treatment known as cognitive behavioral therapy (CBT) may be a
      promising treatment for improving depressive symptoms and for long-term stabilization in
      individuals with BP-I. This study will compare the effectiveness of CBT versus supportive
      psychotherapy in decreasing depression in people with BP-I. Using magnetic resonance imaging
      (MRI), this study will also assess the impact of episodic memory impairment in people with
      BP-I on the success of CBT treatment.

      Participation in this single-blind study will last about 9 months and will include 22 study
      visits. There will be four pretreatment visits, during which participants will undergo a
      variety of tests and procedures, including interviews and questionnaires about depression and
      anxiety; tests on memory, attention, reaction time, and reading; and an MRI scan. Following
      completion of the initial assessments, participants will be randomly assigned to receive CBT
      or supportive psychotherapy. Participants in both groups will attend eighteen 1-hour
      treatment sessions over 5 months. Participants attending CBT sessions will learn specific
      thought processing and behavioral exercises to help reduce depressive symptoms. Participants
      attending psychosocial therapy sessions will learn about signs and symptoms related to
      depression and will be provided support in coping with their depression.

      All participants will be asked to complete Mood and Memory Questionnaires before and after
      the first seven treatment sessions. Psychological evaluations will occur after Visits 8 and
      18 of treatment and will involve the completion of questionnaires. Participants in both
      groups will attend a follow-up visit to evaluate tic symptoms, anxiety, and mood 4 months
      after the final treatment session.
    

Intervention name(s): Supportive Psychotherapy; Cognitive Behavioral Therapy (CBT)
Intervention type(s): Other; Other
Intervention description(s): Participants will attend 18 supportive therapy sessions over 5 months. Supportive psychotherapy focuses on reflecting and expressing feelings about current life issues. Participants are supported and comforted when coping with difficult situations, depression, mood swings, or anger.; Participants will attend 18 CBT sessions over 5 months. CBT for depression targets depressive symptoms through a range of different treatments. This includes psychoeducation about the disorder and educating patients about the role of thoughts and behaviors in the maintenance of depressed mood. CBT also includes mood and activity monitoring, activity scheduling, and teaching participants to critically investigate and challenge negative thoughts and core beliefs that help to maintain depression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive Behavioral Therapy