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Clinical Trials/NCT01783080
NCT01783080
Completed
Not Applicable

Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning

New York State Psychiatric Institute1 site in 1 country16 target enrollmentJune 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Persistent Depressive Disorder
Sponsor
New York State Psychiatric Institute
Enrollment
16
Locations
1
Primary Endpoint
Paid Work Hours at Week 12
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The investigators aimed to assess the ability of a modified version of Behavioral Activation for occupational and social improvement to produce change in: 1. social adjustment, 2. work functioning, 3. avoidance behavior and 4. behavioral activation.

Detailed Description

Psychosocial functioning was assessed before and after BA treatment in medication responsive depressed individuals who continued to have impaired social functioning. The primary goal was to demonstrate feasibility of recruitment and retention, and obtain an open pilot sense as to whether there are benefits from this brief psychotherapy approach in this population. The investigators also planned to refine measures and estimate the effect size of any treatment response to estimate power and sample size with the goal of completing a future controlled study.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
December 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • adults aged 20-75 years
  • a primary diagnosis of Dysthymic Disorder, Chronic major depressive disorder or double depression
  • a \>50% decrease in 17 item Hamilton Rating Scale for Depression (HRSD-17) score and a final HRSD-17 score ≤ 10 with an adequate antidepressant medication (ADM) trial (\> 4 weeks on at least 50% Physician's Desk Reference maximum ADM dose)
  • a rating of 1 ("very much improved") or 2 ("much improved") on the Clinical Global Impressions-Improvement scale (CGI-I)
  • continued functional impairment, defined by scores \>1.9 on the Social Adjustment Scale (SAS)
  • unemployment (jobless, looking for work) according to the Bureau of Labor Statistics: jobless and looking and available for work, or underemployed.

Exclusion Criteria

  • Structured Clinical Interview for Diagnostic and Statistical Manual, fourth edition (DSM-IV) Axis I disorders-diagnosed cognitive or psychotic disorders
  • bipolar disorder
  • active eating disorders
  • severe borderline personality disorder
  • alcohol or drug dependence (except nicotine) in the last 6 months
  • current suicide risk
  • unstable medical conditions
  • use of psychotropic medications other than antidepressants

Outcomes

Primary Outcomes

Paid Work Hours at Week 12

Time Frame: Week 12

Subject-reported paid work hours per week at week 12

Paid Work Hours at Week Baseline

Time Frame: Baseline

Subject-reported paid work hours per week at week baseline

Secondary Outcomes

  • Social Functioning at Week Baseline on the Social Adjustment Scale(baseline)
  • Social Functioning at Week 12 on the Social Adjustment Scale(Week 12)

Study Sites (1)

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