NCT00595387

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

5 years

First QC Date

January 4, 2008

Last Update Submit

April 28, 2015

Conditions

Bipolar DisorderDepression

Keywords

Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (1)

  • Hamilton Depression Rating Scale (HAM-D)

    Measured at baseline and Weeks 9, 20, and 36

Study Arms (2)

1

ACTIVE COMPARATOR

Participants receiving supportive psychotherapy

Other: Supportive Psychotherapy

2

EXPERIMENTAL

Participants receiving cognitive behavioral therapy

Other: Cognitive Behavioral Therapy (CBT)

Interventions

Supportive PsychotherapyOTHER

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.

1
Cognitive Behavioral Therapy (CBT)OTHER

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.

2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital Bipolar Clinic and Research Program

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bipolar DisorderDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Thilo Deckersbach, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant Professor Psychology

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 16, 2008

Study Start

September 1, 2006

Primary Completion

September 1, 2011

Study Completion

January 1, 2013

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

US(1)