Clinical trial NCT02111811: Reducing the Burden of Depression Related Disability
Official title: Reducing the Burden of Depression on Employment: Improving Function and Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Treatment Outcome
Delivery of Healthcare, Integrated
Employment
Rehabilitation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Tufts Medical Center
First posted: 2014-04-11
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Improvement in Work Related Disability Post Intervention
timeFrame: 4 months post randomization
Secondary outcomes:
measure: Sustained Improvement in Work Productivity
timeFrame: 9 months post randomization
measure: The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention.
timeFrame: 9 months post randomization
Other outcomes:
Locations:
city: Coatesville
country: United States
facility: Coatesville VA Medical Center, Coatesville, PA
state: Pennsylvania
city: Philadelphia
country: United States
facility: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
state: Pennsylvania
Study officials:
affiliation: Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
name: David W. Oslin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.