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

Primary Purpose

Bipolar Disorder, Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supportive Psychotherapy
Cognitive Behavioral Therapy (CBT)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Massachusetts General Hospital Bipolar Clinic and Research Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Participants receiving supportive psychotherapy

Participants receiving cognitive behavioral therapy

Outcomes

Primary Outcome Measures

Hamilton Depression Rating Scale (HAM-D)

Secondary Outcome Measures

Full Information

First Posted
January 4, 2008
Last Updated
April 28, 2015
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00595387
Brief Title
Effectiveness of Cognitive Behavioral Therapy for Treating Depression in People With Bipolar I Disorder
Official Title
Cognitive-Behavior Therapy for Bipolar Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depression
Keywords
Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Participants receiving supportive psychotherapy
Arm Title
2
Arm Type
Experimental
Arm Description
Participants receiving cognitive behavioral therapy
Intervention Type
Other
Intervention Name(s)
Supportive Psychotherapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioral Therapy (CBT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hamilton Depression Rating Scale (HAM-D)
Time Frame
Measured at baseline and Weeks 9, 20, and 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thilo Deckersbach, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Bipolar Clinic and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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

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