Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH060735 | U.S. NIH Grant/Contract | View source | |
| DSIR AT-AS |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Depression is a very common problem for people who have had CABG surgery, and recent studies have shown that it may increase the risk of additional medical problems and death during the first few years after surgery. Cognitive behavior therapy (CBT) has been shown to be efficacious for depression in otherwise healthy individuals, and supportive stress management (SSM) interventions have also been shown to improve depressive symptoms. These therapies have not, however, been tested for depression in individuals who have undergone CABG surgery.
Participants will be screened for depression within 1 year after CABG surgery. Those who have depression will return for additional testing 1 week later. Eligible participants will be randomized to receive CBT, SSM, or usual care (UC), with no restrictions on nonstudy antidepressants, for 12 weeks. Patients will be monitored for worsening depression referred for additional care if needed. Depression, anxiety, and health-related quality of life will be assessed at baseline, 12 weeks after randomization, and 6 months after surgery (2 months after termination of CBT or SSM).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive behavior therapy | Behavioral | Up to 12 weekly, individual, hour-long sessions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory | The BDI is a self-report measure of the severity of depression. | 12 weeks post-randomization |
| Beck Anxiety Inventory | The BAI is a self-report measure of the severity of anxiety symptoms. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth E Freedland, Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19349308 | Result | 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. |
| Label | URL |
|---|---|
| Volunteer for Health--Washington University's research volunteer program | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Supportive Stress Management |
| Behavioral |
Up to 12 weekly, individual, hour-long sessions, focusing on application of relaxation and other stress management techniques to depressogenic stressors |
|
| 12 weeks post-randomization |
| Beck Hopelessness Scale | The BHS is a self-report measure of hopelessness. | 12 weeks post-randomization |
| Perceived Stress Scale | The PSS is a self-report measure of perceived stress | 12 weeks post-randomization |
| SF-36 | The Medical Outcomes Study SF-36 is a measure of health-related quality of life. The Physical and Mental factor scores will be reported. | 12 weeks post-randomization |
| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |