Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder
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|ClinicalTrials.gov Identifier: NCT00595387|
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : April 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Depression||Other: Supportive Psychotherapy Other: Cognitive Behavioral Therapy (CBT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Cognitive-Behavior Therapy for Bipolar Disorder|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||January 2013|
Active Comparator: 1
Participants receiving supportive psychotherapy
Other: Supportive Psychotherapy
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 receiving cognitive behavioral therapy
Other: Cognitive Behavioral Therapy (CBT)
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.
- Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured at baseline and Weeks 9, 20, and 36 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595387
|United States, Massachusetts|
|Massachusetts General Hospital Bipolar Clinic and Research Program|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Thilo Deckersbach, PhD||Massachusetts General Hospital|