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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David J. Hellerstein, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01783080
First received: January 25, 2013
Last updated: January 31, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Medication-responsive Chronic Depression (CD).
Behavioral: Behavioral Activation for return to work

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning

Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Paid work hours at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Subject-reported paid work hours per week at week 24 follow-up.

  • Attainment of work-related goals at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Attainment of work goals was measured using the Goal Attainment Scale (GAS). A research MD (D.H.) rated the GAS at Week 24 for primary outcome.


Secondary Outcome Measures:
  • Social functioning at week 24 on the Social Adjustment Scale [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    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.

  • Behavioral activation at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Level of behavioral activation was measured by the Behavioral Activation for Depression Scale (BADS), a 25-item self-report measure with four subscales corresponding to levels of activation, avoidance, work / school impairment and social impairment.

  • Social adjustment at week 24 on the Quality of Life Questionnaire [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Social adjustment was also measured using the Quality of Life Enjoyment Satisfaction Questionnaire, short form. The Quality of Life Enjoyment Satisfaction Questionnaire is a 16 item inventory designed to assess the degree of enjoyment and satisfaction experienced in areas of daily functioning.

  • Behavioral Avoidance at week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
    Behavioral Avoidance was measured with the Cognitive and Behavior Avoidance Scale (CBAS), a 31-item patient rated scale with subscales corresponding to avoidance in 4 areas: cognitive social, cognitive non-social, behavioral social and behavioral non-social.


Enrollment: 16
Study Start Date: June 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Behavioral Activation for Return to Work (BA-W)
BA is a manualized psychotherapy which has demonstrated comparable efficacy to cognitive behavioral treatment and antidepressant medication for the acute treatment of depression. BA has two primary foci: 1) functional analyses of cognitive and behavioral processes that involve avoidance and 2) using avoided activities to guide activity scheduling. In the current study, BA's focus but not its principles 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 rationale viewed 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.
Behavioral: Behavioral Activation for return to work
See Arm Description

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01783080

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: David J Hellerstein, MD New York State Psychiatric Institute
  More Information

No publications provided

Responsible Party: David J. Hellerstein, Principal Investigator, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01783080     History of Changes
Other Study ID Numbers: NYSPI5908
Study First Received: January 25, 2013
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Chronic depression
Dysthymic disorder
Double Depression
Behavioral Activation therapy
Work impairment
Unemployment

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014