NCT00042198

Brief Summary

This randomized controlled trial will test the efficacy of (1) cognitive behavior therapy and (2) supportive stress management as treatments for depression in people who have recently undergone coronary artery bypass graft surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Dec 2001

Longer than P75 for not_applicable depression

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

July 2, 2013

Status Verified

July 1, 2013

Enrollment Period

4 years

First QC Date

July 24, 2002

Last Update Submit

July 1, 2013

Conditions

DepressionCoronary Disease

Keywords

Cognitive therapyRelaxation techniques

Outcome Measures

Primary Outcomes (1)

  • Hamilton Rating Scale for Depression (HAM-D-17)

    The HAM-D-17 is an observer-rated measure of the severity of depression.

    12 weeks post-randomization

Secondary Outcomes (5)

  • Beck Depression Inventory

    12 weeks post-randomization

  • Beck Anxiety Inventory

    12 weeks post-randomization

  • Beck Hopelessness Scale

    12 weeks post-randomization

  • Perceived Stress Scale

    12 weeks post-randomization

  • SF-36

    12 weeks post-randomization

Study Arms (3)

1

EXPERIMENTAL

Cognitive Behavior Therapy. The treatment modality was individual, face-to-face therapy with an experienced cognitive therapist. Treatment consisted of up to 12 weekly, hour-long sessions.

Behavioral: Cognitive behavior therapy

2

ACTIVE COMPARATOR

Supportive Stress Management. The treatment modality was individual, face-to-face therapy with an experienced psychotherapist. Treatment consisted of up to 12 weekly, hour-long sessions.

Behavioral: Supportive Stress Management

3

NO INTERVENTION

Usual Care, minimally enhanced. Participants in all three arms were given information about depression. There were no restrictions in any of the arms on usual care for depression, heart disease, or any other conditions, except that concurrent participation in nonstudy psychotherapy was not allowed. Participants were allowed to continue or start on nonstudy antidepressants during the study, as prescribed by the participant's personal physician.

Interventions

Cognitive behavior therapyBEHAVIORAL

Up to 12 weekly, individual, hour-long sessions

1
Supportive Stress ManagementBEHAVIORAL

Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors

2

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Coronary Artery Bypass Graft (CABG) surgery (alone or combined with valvular or carotid surgery) within past 12 months
  • Meets DSM-IV criteria for major or minor depressive episode

You may not qualify if:

  • Severe cognitive impairment
  • Severe psychiatric comorbidity (e.g., alcoholism or schizophrenia)
  • Severely debilitating or life-threatening illness other than coronary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • Freedland KE, Skala JA, Carney RM, Rubin EH, Lustman PJ, Davila-Roman VG, Steinmeyer BC, Hogue CW Jr. Treatment of depression after coronary artery bypass surgery: a randomized controlled trial. Arch Gen Psychiatry. 2009 Apr;66(4):387-96. doi: 10.1001/archgenpsychiatry.2009.7.

    PMID: 19349308RESULT

Related Links

MeSH Terms

Conditions

DepressionCoronary Disease

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Kenneth E Freedland, Ph.D.

    Washington University School of Medicine

    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
Professor of Psychiatry

Study Record Dates

First Submitted

July 24, 2002

First Posted

July 26, 2002

Study Start

December 1, 2001

Primary Completion

December 1, 2005

Study Completion

August 1, 2006

Last Updated

July 2, 2013

Record last verified: 2013-07

Locations

US(1)