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CompletedNCT00595387Updated Apr 29, 2015

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

An interventional study of Supportive Psychotherapy and Cognitive Behavioral Therapy (CBT) in Bipolar Disorder and Depression, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2015-04-29.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Bipolar Disorder
  • Depression

Keywords

  • Cognitive Behavioral Therapy
03

In context

Depression

8,055 studies on the registry are indexed under Depression; 1,643 are open to participants now.

This study's enrollment of 54 is below the median of 84 across 6,718 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,537 studies on the registry; 448 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
54 participants (actual)

Study arms

  • Active comparator
    1

    Participants receiving supportive psychotherapy

    Other: Supportive Psychotherapy

  • Experimental
    2

    Participants receiving cognitive behavioral therapy

    Other: Cognitive Behavioral Therapy (CBT)

Interventions

  • OtherSupportive 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.

  • OtherCognitive 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.

06

What researchers measure

Primary outcomes

  1. Hamilton Depression Rating Scale (HAM-D)

    Time frame: Measured at baseline and Weeks 9, 20, and 36

07

Study locations

1 site
  • Massachusetts General Hospital Bipolar Clinic and Research Program
    Boston, Massachusetts 02114, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00595387
Lead sponsor
Massachusetts General Hospital
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Thilo Deckersbach (PhD, Assistant Professor Psychology, Massachusetts General Hospital) — Principal investigator
First posted
Jan 16, 2008
Start date
Sep 2006
Primary completion
Sep 2011
Completion
Jan 2013
Last update
Apr 29, 2015

Study contacts

Thilo Deckersbach, PhD
principal investigator · Massachusetts General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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