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

Not Applicable
Completed
Conditions
Persistent Depressive Disorder
Interventions
Behavioral: Behavioral Activation for return to work
Registration Number
NCT01783080
Lead Sponsor
New York State Psychiatric Institute
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Behavioral Activation for Return to WorkBehavioral Activation for return to workBA is a manualized psychotherapy with comparable efficacy to cognitive behavioral treatment and antidepressant medication for acute treatment of depression. In this study, BA's focus was shifted to target work dysfunction by activating the patient into employment-related goals. BA-W consisted of 12 50-minute weekly sessions. Conceptualizing work dysfunction as a product of avoidance patterns and low levels of positive reinforcement, the treatment addressed maladaptive coping strategies such as avoidance as maintaining work dysfunction beyond remission of symptoms. Rather than broadly activating patients, activity scheduling focused on tasks such as sending out resumes, calling for job interviews, and networking to meet potential employers.
Primary Outcome Measures
NameTimeMethod
Paid Work Hours at Week 12Week 12

Subject-reported paid work hours per week at week 12

Paid Work Hours at Week BaselineBaseline

Subject-reported paid work hours per week at week baseline

Secondary Outcome Measures
NameTimeMethod
Social Functioning at Week Baseline on the Social Adjustment Scalebaseline

Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome ... worse functioning

Social Functioning at Week 12 on the Social Adjustment ScaleWeek 12

Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome ... worse functioning

Trial Locations

Locations (1)

New York State Psychiatric Institute

🇺🇸

New York, New York, United States

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