N/A
Completed N=16
Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
Persistent Depressive Disorder
Source: ClinicalTrials.gov NCT01783080 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcomePrimary: Paid Work Hours at Week 12 — 30.3 hours — p=0.005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Paid Work Hours at Week 12 |
30.3 | 0.005 sig |
| PRIMARY Paid Work Hours at Week Baseline |
16.9 | — |
| SECONDARY Social Functioning at Week Baseline on the Social Adjustment Scale |
2.4 | 0.11 |
| SECONDARY Social Functioning at Week 12 on the Social Adjustment Scale |
2.18 | — |
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
Data sourced from ClinicalTrials.gov (NCT01783080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.