Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder
Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder
This study will compare the effectiveness of cognitive behavioral therapy versus supportive
 psychotherapy in decreasing depression in people with bipolar disorder.
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.
Inclusion Criteria:

 -  Normal or corrected-to-normal vision (tested by vision charts)

 -  Diagnosis of bipolar I disorder by the Mini International Neuropsychiatric Interview
 (MINI)

 -  HAM-D score of 17 or higher

 Exclusion Criteria:

 -  Meets criteria for DSM-IV bipolar I disorder subtype rapid cycling

 -  Meets criteria for DSM-IV mixed episode

 -  Pregnant

 -  Serious medical illness

 -  Neurologic disorder and/or head trauma

 -  Current or past history of selected DSM-IV Axis I disorders other than bipolar
 disorder, including organic mental disorder, schizophrenia, delusional disorder, and
 psychotic disorders not otherwise specified

 -  Substance abuse or dependence within the 12 months prior to study entry and/or history
 of substance abuse for more than 12 months

 -  IQ of less than 80 on the Wechsler Adult Reading Test

 -  Previous treatment with CBT for depression

 -  Contraindications to MRI (e.g., metallic implants, claustrophobia)