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Clinical Trials/NCT02111811
NCT02111811
Completed
Not Applicable

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

VA Office of Research and Development2 sites in 1 country253 target enrollmentMay 19, 2014
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
VA Office of Research and Development
Enrollment
253
Locations
2
Primary Endpoint
Improvement in Work Related Disability Post Intervention
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 19, 2014
End Date
December 30, 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Improvement in Work Related Disability Post Intervention

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (2)

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