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

New York State Psychiatric Institute16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Persistent Depressive Disorder

Interventions

Behavioral Activation for return to workBEHAVIORAL

See Arm Description

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

New York State Psychiatric Institute

New York, New York, United States

Outcomes

Primary Outcomes

Paid Work Hours at Week 12

Subject-reported paid work hours per week at week 12

Time frame: Week 12

Paid Work Hours at Week Baseline

Subject-reported paid work hours per week at week baseline

Time frame: Baseline

Secondary Outcomes

Social Functioning at Week Baseline on the Social Adjustment Scale

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

Time frame: baseline

Social Functioning at Week 12 on the Social Adjustment Scale

Time frame: Week 12

Data from ClinicalTrials.gov

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