Reducing the Burden of Depression Related Disability

NCT ID: NCT02111811

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 253 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-19
• Study Completion Date: 2017-12-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Be Well At Work intervention + IC

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

Group Type: EXPERIMENTAL

Veterans Work and Health Initiative

Intervention Type: OTHER

CBT based intervention focused on work productivity

Integrated Care Only

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Veterans Work and Health Initiative

CBT based intervention focused on work productivity

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts Medical Center

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David W. Oslin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Coatesville VA Medical Center, Coatesville, PA

Coatesville, Pennsylvania, United States

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

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 32108889 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

I01RX001132-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D1132-R

Identifier Type: -

Identifier Source: org_study_id