This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01783080
First received: January 25, 2013
Last updated: April 4, 2017
Last verified: April 2017
  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
Persistent Depressive Disorder Behavioral: Behavioral Activation for return to work

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 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 Outcome Measures:
  • 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

  • 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


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 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.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01783080     History of Changes
Other Study ID Numbers: #5908
Study First Received: January 25, 2013
Results First Received: January 5, 2017
Last Updated: April 4, 2017
Individual Participant Data  
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on June 23, 2017