跳至主要内容
临床试验/NCT02111811
NCT02111811已完成不适用

Reducing the Burden of Depression on Employment: Improving Function and Work

VA Office of Research and Development4 个研究点 分布在 1 个国家目标入组 253 人开始时间: 2014年5月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
253
试验地点
4
主要终点
Improvement in Work Related Disability Post Intervention

研究概览

简要总结

The purpose of this research study is to test the effectiveness of a new telephone counseling program for employed Veterans with depression called the Veterans Work and Health Initiative (V-WHI) using the Be Well at Work (BWAW) intervention. 250 participants will be recruited and randomly assigned to one of two groups: the V-WHI experimental group or usual mental health care. The V-WHI counselors will address mental health and job-related issues that interfere with working. This counseling is provided solely over the phone with sessions every 2 weeks for 4 months (eight sessions total). At 8 months post-baseline, the V-WHI group is provided with a booster session. Participants in both groups are administered follow-up questionnaires at two time-points: month four and month nine.

详细描述

With the goal of helping employed Veterans with depression to participate fully in the labor market, this randomized controlled trial has two objectives: 1) test the effectiveness of a new evidence-based, vocationally-focused telephonic counseling program for employed Veterans with depression, the Veterans Work and Health Initiative (V-WHI), which was developed by this study's research partners from the Tufts Medical Center; and 2) if the V-WHI is effective, quantify its return on investment. This study will test the impact of the BWAW intervention in combination with the Philadelphia VA's Primary Care Mental Health Integration program, the Behavioral Health Lab (BHL).

For the main hypothesis, concerning the effect of BWAW, the primary endpoint is the post-intervention at-work mean productivity loss score based on the validated Work Limitation Questionnaire (WLQ) adjusted for baseline score. For Hypothesis 2, concerning maintenance of post-intervention effects at nine months, the primary outcome is the mean difference of the change in productivity loss score. For hypothesis 3, the primary outcome was the return on investment (ROI) from BWAW.

After informed consent and eligibility screening, subjects are randomized to one of two groups: the V-WHI intervention group or to the usual care group (BHL). 250 employed Veterans with depression and work limitations will be enrolled (half per group). The "usual care" group participants are assigned to standard behavioral health care. The second group, assigned to BWAW intervention, is the experimental group. Participants in this group are assigned to an innovative program designed explicitly to address mental health and vocational issues that interfere with working in addition to standard care. V-WHI counselors offer work coaching and modification strategies and work-focused cognitive behavioral therapy (CBT). This counseling is provided solely over the phone with sessions every 2 weeks for 4 months (eight sessions total). At 8 months post-baseline, the V-WHI group is provided with a booster session. Participants in both groups are administered follow-up questionnaires at two time-points: month four (post-intervention) and month nine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Veterans will be considered eligible for study participation if the following criteria are met:
  • 18 years of age (no maximum age is specified)
  • working for pay 15 hours per week
  • employed in the job for 6 months (to ensure that the Veteran has sufficient familiarity with the position and organization)
  • current major depression and/or persistent depressive disorder symptoms based on DSM-5 criteria
  • and current work limitations

排除标准

  • Non-English speaking or reading
  • bipolar disorder
  • psychosis
  • and/or planning to take maternity leave at any point in the next nine months

结局指标

主要结局

Improvement in Work Related Disability Post Intervention

时间窗: 4 months post randomization

The outcome measure is the mean difference of the changes from baseline to time 1. The mean differences are then compared. The WLQ scale range=0-25 with higher scores indicating greater difficulty.

次要结局

  • Sustained Improvement in Work Productivity(9 months post randomization)
  • The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention.(9 months post randomization)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验

Reducing the Burden of Depression Related Disability | 临床试验