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NCT Number: NCT02111811

Reducing the Burden of Depression Related Disability

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Coatesville VA Medical Center, Coatesville, PA, Coatesville, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Veterans Work and Health Initiative

Other

CBT based intervention focused on work productivity

Primary outcomes

  1. 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

  1. Sustained Improvement in Work Productivity

    Time frame: 9 months post randomization

    The outcome measure is the mean difference of the changes from baseline until about 9 months post randomization. The mean differences are then compared. The WLQ scale range=0-25 with higher scores indicating greater difficulty.

  2. The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention.

    Time frame: 9 months post randomization

    This variable is defined as: [marginal benefit on patient work productivity attributable to the V-WHI intervention] - [marginal cost of supplementing IC with V-WHI) / [marginal cost of supplementing IC with V-WHI]. The comparison assessed the monetized value of the difference in pre to post treatment changes in at-work productivity loss (presenteeism) + the monetized value of the difference in the changes in productivity loss due to work absences. Because both productivity loss components were measured at baseline and two follow-ups, the changes between time points (baseline to month 4 and month 4 to month 8/9) were first averaged before computing their difference.

    The marginal costs attributable to V-WHI included the full costs of the providing the counseling treatment and supervision of the counselors.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Collaborators

  • Tufts Medical Center

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Apr 11, 2014
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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