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Completed

NCT Number: NCT01783080

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

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.

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Key information

Conditions

Persistent Depressive Disorder Depressive Disorder Dysthymic Disorder Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation for return to work

Behavioral

See Arm Description

Primary outcomes

  1. Paid Work Hours at Week 12

    Time frame: Week 12

    Subject-reported paid work hours per week at week 12

  2. Paid Work Hours at Week Baseline

    Time frame: Baseline

    Subject-reported paid work hours per week at week baseline

Secondary outcomes

  1. Social Functioning at Week Baseline on the Social Adjustment Scale

    Time frame: baseline

    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

  2. Social Functioning at Week 12 on the Social Adjustment Scale

    Time frame: Week 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

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 4, 2013
Registry last updated
Jun 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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