Research Evaluating the Value of Augmenting Medication With Psychotherapy (REVAMP)

Weill Cornell Medicine (WCM)

Status and phase: Completed; Phase 4

Conditions: Depression; Depressive Disorder

Treatments: Behavioral: Brief Supportive Psychotherapy; Behavioral: CBASP; Drug: Medication Only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00057551

U01MH062491 (U.S. NIH Grant/Contract)

U01MH062465 (U.S. NIH Grant/Contract)

U01MH061504 (U.S. NIH Grant/Contract)

U01MH061562 (U.S. NIH Grant/Contract)

U01MH062475 (U.S. NIH Grant/Contract)

U01MH062546 (U.S. NIH Grant/Contract)

U01MH063481 (U.S. NIH Grant/Contract)

U01MH061587 (U.S. NIH Grant/Contract)

U01MH061590 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This 24-week study, with a 12-month follow up period, will compare the effectiveness of antidepressant medication alone to the combination of psychotherapy and antidepressant medication in patients with chronic depression.

Full description

Chronic depression affects approximately 5% of adults in the United States and is associated with significant functional impairment and high health care utilization. The combination of drug treatment and psychotherapy may be most effective in treating depression. This study will determine the effects of adjunctive psychotherapy in depressed patients who have failed to respond or have responded only partially to an initial trial medication.

Participants receive an initial trial of antidepressant medication for 8 to 12 weeks. Participants who continue to have depressive symptoms are randomly assigned to add Cognitive Behavioral Analysis System of Psychotherapy (CBASP) or supportive therapy to their medication regimens or to continue pharmacotherapy alone for an additional 12 weeks. Assessments are made at 6 and 12 months post-treatment.

Enrollment: 491 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Major depressive episode
• Depressive symptoms > 2 years without remission
• Hamilton Depression Scale (HAM-D) score > 20
• Fluent in English

Exclusion Criteria

• Psychotic disorders, bipolar disorder, post traumatic stress disorder, obsessive compulsive disorder, or eating disorder
• Serious, unstable, or terminal medical condition
• Axis II diagnosis of antisocial, schizotypal, or severe borderline personality disorder
• Previous treatment with CBASP
• Previous ineffective treatment with 4 of the medication treatments used in the study
• Substance abuse
• Pregnancy
• Not willing to end other psychiatric treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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491 participants in 3 patient groups

CBASP

Experimental group

Description:

Cognitive Behavioral System of Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)

Treatment:

Behavioral: CBASP

Brief Supportive Psychotherapy

Active Comparator group

Description:

Brief Supportive Psychotherapy plus medication (Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine)

Treatment:

Behavioral: Brief Supportive Psychotherapy

Medication Only

Active Comparator group

Description:

Could be switch to or addition of escitalopram, bupropion, venlafaxine or mirtazapine

Treatment:

Drug: Medication Only