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

NCT01783080 | Completed Results DMC

• 1 other identifier: #5908
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Persistent Depressive Disorder

Keywords

Chronic depression; Dysthymic disorder; Double Depression; Behavioral Activation therapy; Work impairment; Unemployment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Social Functioning at Week Baseline on the Social Adjustment Scale

  baseline

• Social Functioning at Week 12 on the Social Adjustment Scale

  Week 12

Study Arms (1)

Behavioral Activation for Return to Work

EXPERIMENTAL

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

Interventions

Behavioral Activation for return to work BEHAVIORAL

See Arm Description

Behavioral Activation for Return to Work

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 21586994 BACKGROUND

• 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.

  PMID: 25464836 RESULT

MeSH Terms

Conditions

Dysthymic Disorder

Interventions

Return to Work

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Employment; Socioeconomic Factors; Population Characteristics

Limitations and Caveats

This was a small open treatment study, without a comparator group and with limited followup. Findings of this pilot study should be replicated in a larger prospective trial with a randomized design, and with longer followup.

Results Point of Contact

• Title: David J Hellerstein MD, Professor of Clinical Psychiatry, Columbia
• Organization: NY State Psychiatric Institute

hellers@nypsi.columbia.edu

646-774-8000

Study Officials

• David J Hellerstein, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: February 4, 2013
• Study Start: June 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 19, 2017
• Results First Posted: June 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)