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Reducing the Burden of Depression Related Disability

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Veterans Work and Health Initiative
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Treatment Outcome, Delivery of Healthcare, Integrated, Employment, Rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Coatesville VA Medical Center, Coatesville, PA
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Be Well At Work intervention + IC

Integrated Care Only

Arm Description

CBT based intervention focused on work productivity plus integrated care as usual

usual care group (Behavioral Health lab care at the PVAMC)

Outcomes

Primary Outcome Measures

Improvement in Work Related Disability Post Intervention
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 Outcome Measures

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

Full Information

First Posted
March 31, 2014
Last Updated
April 16, 2020
Sponsor
VA Office of Research and Development
Collaborators
Tufts Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02111811
Brief Title
Reducing the Burden of Depression Related Disability
Official Title
Reducing the Burden of Depression on Employment: Improving Function and Work
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 19, 2014 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
Tufts Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Treatment Outcome, Delivery of Healthcare, Integrated, Employment, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Be Well At Work intervention + IC
Arm Type
Experimental
Arm Description
CBT based intervention focused on work productivity plus integrated care as usual
Arm Title
Integrated Care Only
Arm Type
No Intervention
Arm Description
usual care group (Behavioral Health lab care at the PVAMC)
Intervention Type
Other
Intervention Name(s)
Veterans Work and Health Initiative
Intervention Description
CBT based intervention focused on work productivity
Primary Outcome Measure Information:
Title
Improvement in Work Related Disability Post Intervention
Description
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.
Time Frame
4 months post randomization
Secondary Outcome Measure Information:
Title
Sustained Improvement in Work Productivity
Description
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.
Time Frame
9 months post randomization
Title
The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention.
Description
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.
Time Frame
9 months post randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David W. Oslin, MD
Organizational Affiliation
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coatesville VA Medical Center, Coatesville, PA
City
Coatesville
State/Province
Pennsylvania
ZIP/Postal Code
19320
Country
United States
Facility Name
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32108889
Citation
Lerner D, Adler DA, Rogers WH, Ingram E, Oslin DW. Effect of Adding a Work-Focused Intervention to Integrated Care for Depression in the Veterans Health Administration: A Randomized Clinical Trial. JAMA Netw Open. 2020 Feb 5;3(2):e200075. doi: 10.1001/jamanetworkopen.2020.0075.
Results Reference
result

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Reducing the Burden of Depression Related Disability

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