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.

Study Overview

• Status: Completed
• Conditions: Persistent Depressive Disorder
• Intervention / Treatment: Behavioral: Behavioral Activation for return to work

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paid Work Hours at Week 12	Subject-reported paid work hours per week at week 12	Week 12
Paid Work Hours at Week Baseline	Subject-reported paid work hours per week at week baseline	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline
Social Functioning at Week 12 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	Week 12

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Investigators: Principal Investigator: David J Hellerstein, MD, New York State Psychiatric Institute

Publications and helpful links

General Publications

• Erickson G, Hellerstein DJ. Behavioral activation therapy for remediating persistent social deficits in medication-responsive chronic depression. J Psychiatr Pract. 2011 May;17(3):161-9. doi: 10.1097/01.pra.0000398409.21374.ab.
• Hellerstein DJ, Erickson G, Stewart JW, McGrath PJ, Hunnicutt-Ferguson K, Reynolds SK, O'Shea D, Chen Y, Withers A, Wang Y. Behavioral activation therapy for return to work in medication-responsive chronic depression with persistent psychosocial dysfunction. Compr Psychiatry. 2015 Feb;57:140-7. doi: 10.1016/j.comppsych.2014.10.015. Epub 2014 Nov 7.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: January 25, 2013
• First Submitted That Met QC Criteria: January 31, 2013
• First Posted (Estimate): February 4, 2013

Study Record Updates

• Last Update Posted (Actual): June 19, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Dysthymic disorder; Unemployment; Chronic depression; Double Depression; Behavioral Activation therapy; Work impairment
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: #5908

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO