Behavioral Activation (BA) for Medication-responsive Chronically Depressed Patients With Impaired Social Functioning
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Paid Work Hours at Week 12
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Behavioral Activation for return to work (Behavioral)
结局指标
主要结局
Paid Work Hours at Week 12
时间窗: Week 12
Subject-reported paid work hours per week at week 12
Paid Work Hours at Week Baseline
时间窗: Baseline
Subject-reported paid work hours per week at week baseline
次要结局
- Social Functioning at Week Baseline on the Social Adjustment Scale(baseline)
- Social Functioning at Week 12 on the Social Adjustment Scale(Week 12)