Clinical trial NCT01783080: Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Official title: Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Depressive Disorder
Keywords: Chronic depression
Dysthymic disorder
Double Depression
Behavioral Activation therapy
Work impairment
Unemployment
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2013-02-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Paid Work Hours at Week 12
timeFrame: Week 12
measure: Paid Work Hours at Week Baseline
timeFrame: Baseline
Secondary outcomes:
measure: Social Functioning at Week Baseline on the Social Adjustment Scale
timeFrame: baseline
measure: Social Functioning at Week 12 on the Social Adjustment Scale
timeFrame: Week 12
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: David J Hellerstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.