Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Thilo Deckersbach, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00595387
First received: January 4, 2008
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Bipolar Disorder
Depression
Other: Supportive Psychotherapy
Other: Cognitive Behavioral Therapy (CBT)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive-Behavior Therapy for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Measured at baseline and Weeks 9, 20, and 36 ] [ Designated as safety issue: No ]

Estimated Enrollment: 70
Study Start Date: September 2006
Estimated Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Experimental: 2
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595387

Locations
United States, Massachusetts
Massachusetts General Hospital Bipolar Clinic and Research Program
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Thilo Deckersbach, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Thilo Deckersbach, PhD, Assistant Professor Psychology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00595387     History of Changes
Other Study ID Numbers: 2006P001521, K23MH074895, DSIR 83-ATP
Study First Received: January 4, 2008
Last Updated: April 19, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 19, 2014