Reducing the Burden of Depression Related Disability
Study Details
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Be Well At Work intervention + IC CBT based intervention focused on work productivity plus integrated care as usual |
Other: Veterans Work and Health Initiative
CBT based intervention focused on work productivity
|
No Intervention: Integrated Care Only usual care group (Behavioral Health lab care at the PVAMC) |
Outcome Measures
Primary Outcome Measures
- Improvement in Work Related Disability Post Intervention [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 Outcome Measures
- Sustained Improvement in Work Productivity [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.
- The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention. [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.
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Coatesville VA Medical Center, Coatesville, PA | Coatesville | Pennsylvania | United States | 19320 |
2 | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- VA Office of Research and Development
- Tufts Medical Center
Investigators
- Principal Investigator: David W. Oslin, MD, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Study Documents (Full-Text)
More Information
Publications
None provided.- D1132-R
- I01RX001132-01A1
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Veterans Work and Health Initiative | Integreated Care Only |
---|---|---|
Arm/Group Description | Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity | usual care group (Integrated care services only) |
Period Title: Treatment Phase | ||
STARTED | 139 | 114 |
COMPLETED | 115 | 96 |
NOT COMPLETED | 24 | 18 |
Period Title: Treatment Phase | ||
STARTED | 139 | 114 |
COMPLETED | 111 | 97 |
NOT COMPLETED | 28 | 17 |
Baseline Characteristics
Arm/Group Title | Veterans Work and Health Initiative | Integreated Care Only | Total |
---|---|---|---|
Arm/Group Description | Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity | usual care group (Integrated care services only) | Total of all reporting groups |
Overall Participants | 139 | 114 | 253 |
Age (years) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [years] |
46.5
(11.6)
|
44.8
(11.6)
|
45.7
(11.6)
|
Sex: Female, Male (Count of Participants) | |||
Female |
17
12.2%
|
18
15.8%
|
35
13.8%
|
Male |
122
87.8%
|
96
84.2%
|
218
86.2%
|
Race (NIH/OMB) (Count of Participants) | |||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
Black or African American |
60
43.2%
|
58
50.9%
|
118
46.6%
|
White |
79
56.8%
|
56
49.1%
|
135
53.4%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||
United States |
139
100%
|
114
100%
|
253
100%
|
Depression Severity (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
14.8
(4.8)
|
14.1
(4.9)
|
14.5
(4.8)
|
Work Productivity Lost Score (units on a scale) [Mean (Standard Deviation) ] | |||
Mean (Standard Deviation) [units on a scale] |
12.4
(4.9)
|
12.3
(4.5)
|
12.3
(4.7)
|
Outcome Measures
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 |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Veterans Work and Health Initiative | Integreated Care Only |
---|---|---|
Arm/Group Description | Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity | usual care group (Integrated care services only) |
Measure Participants | 115 | 96 |
Mean (95% Confidence Interval) [units on a scale] |
-2.1
|
-0.09
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
There were more subjects available at 9 months than at the end of the trial (4 months) as we attempted to contact all patients who had not withdrawn. We were able to reach a few at 9 months who were not available at 4. |
Arm/Group Title | Veterans Work and Health Initiative | Integreated Care Only |
---|---|---|
Arm/Group Description | Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity | usual care group (Integrated care services only) |
Measure Participants | 111 | 97 |
Mean (95% Confidence Interval) [score on a scale] |
-3.4
|
-.8
|
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 |
Outcome Measure Data
Analysis Population Description |
---|
The marginal costs attributable to V-WHI included the full costs of the providing the counseling treatment and supervision of the counselors. The ROI analysis did not evaluate costs other than the V-WHI costs, including standard care provided to both the IC only group and the IC+V-WHI group. |
Arm/Group Title | Veterans Work and Health Initiative |
---|---|
Arm/Group Description | Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity |
Measure Participants | 111 |
Number [marginal benefit in ($)] |
900
|
Adverse Events
Time Frame | 9 months of the trial | |||
---|---|---|---|---|
Adverse Event Reporting Description | Asked at the follow up assessments. | |||
Arm/Group Title | Veterans Work and Health Initiative | Integreated Care Only | ||
Arm/Group Description | Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity | usual care group (Integrated care services only) | ||
All Cause Mortality |
||||
Veterans Work and Health Initiative | Integreated Care Only | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 2/139 (1.4%) | 0/114 (0%) | ||
Serious Adverse Events |
||||
Veterans Work and Health Initiative | Integreated Care Only | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 7/139 (5%) | 10/114 (8.8%) | ||
Surgical and medical procedures | ||||
Hospitalization | 7/139 (5%) | 7 | 10/114 (8.8%) | 10 |
Other (Not Including Serious) Adverse Events |
||||
Veterans Work and Health Initiative | Integreated Care Only | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/139 (0%) | 0/114 (0%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | David Oslin, MD |
---|---|
Organization | Crescenz VA Medical Center |
Phone | 215-823-8594 |
dave.oslin@va.gov |
- D1132-R
- I01RX001132-01A1