Depression
Conditions
Keywords
Depression, Treatment Outcome, Delivery of Healthcare, Integrated, Employment, Rehabilitation
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.
Interventions
OTHERVeterans Work and Health Initiative
CBT based intervention focused on work productivity
Sponsors
Tufts Medical Center
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Veterans Work and Health Initiative Integrated care services plus a CBT based intervention focused on work productivity
Veterans Work and Health Initiative: CBT based intervention focused on work productivity | 139 |
| Integreated Care Only usual care group (Integrated care services only) | 114 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow up Period (Aim 2) | Death | 2 | 0 |
| Follow up Period (Aim 2) | Lost to Follow-up | 26 | 17 |
| Treatment Phase | Death | 2 | 0 |
| Treatment Phase | Lost to Follow-up | 22 | 18 |
Baseline characteristics
| Characteristic | Veterans Work and Health Initiative | Integreated Care Only | Total |
|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 11.6 | 44.8 years STANDARD_DEVIATION 11.6 | 45.7 years STANDARD_DEVIATION 11.6 |
| Depression Severity | 14.8 units on a scale STANDARD_DEVIATION 4.8 | 14.1 units on a scale STANDARD_DEVIATION 4.9 | 14.5 units on a scale STANDARD_DEVIATION 4.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 60 Participants | 58 Participants | 118 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 79 Participants | 56 Participants | 135 Participants |
| Region of Enrollment United States | 139 Participants | 114 Participants | 253 Participants |
| Sex: Female, Male Female | 17 Participants | 18 Participants | 35 Participants |
| Sex: Female, Male Male | 122 Participants | 96 Participants | 218 Participants |
| Work Productivity Lost Score | 12.4 units on a scale STANDARD_DEVIATION 4.9 | 12.3 units on a scale STANDARD_DEVIATION 4.5 | 12.3 units on a scale STANDARD_DEVIATION 4.7 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 139 | 0 / 114 |
| other Total, other adverse events | 0 / 139 | 0 / 114 |
| serious Total, serious adverse events | 7 / 139 | 10 / 114 |
Outcome results
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.
Time frame: 4 months post randomization
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Veterans Work and Health Initiative | Improvement in Work Related Disability Post Intervention | -2.1 units on a scale |
| Integreated Care Only | Improvement in Work Related Disability Post Intervention | -0.09 units on a scale |
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.
Time frame: 9 months post randomization
Population: 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 | Measure | Value (MEAN) |
|---|---|---|
| Veterans Work and Health Initiative | Sustained Improvement in Work Productivity | -3.4 score on a scale |
| Integreated Care Only | Sustained Improvement in Work Productivity | -.8 score on a scale |
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.
Time frame: 9 months post randomization
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Veterans Work and Health Initiative | The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention. | 900 marginal benefit in ($) |