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

NCT ID: NCT01783080

Last Updated: 2017-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-12-31

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.

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.

Conditions

Persistent Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral Activation for return to work

Intervention Type: BEHAVIORAL

See Arm Description

Interventions

Behavioral Activation for return to work

See Arm Description

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New York State Psychiatric Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David J Hellerstein, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Locations

New York State Psychiatric Institute

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21586994 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25464836 (View on PubMed)

Other Identifiers

#5908

Identifier Type: -

Identifier Source: org_study_id