Reducing the Burden of Depression Related Disability

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111811
• Other study ID #: D1132-R
• Secondary ID: I01RX001132-01A1
• Status: Completed
• Phase: N/A
• Start date: May 19, 2014
• Est. completion date: December 30, 2017

Study information

• Verified date: April 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: December 30, 2017
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Other:
• Veterans Work and Health Initiative
CBT based intervention focused on work productivity

Locations

Country	Name	City	State
United States	Coatesville VA Medical Center, Coatesville, PA	Coatesville	Pennsylvania
United States	Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	Tufts Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/jam — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 months post randomization
Secondary	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.	9 months post randomization
Secondary	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.	9 months post randomization