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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX001132-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Tufts Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Be Well At Work intervention + IC | Experimental | CBT based intervention focused on work productivity plus integrated care as usual |
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| Integrated Care Only | No Intervention | usual care group (Behavioral Health lab care at the PVAMC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Veterans Work and Health Initiative | Other | CBT based intervention focused on work productivity |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention. |
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Inclusion Criteria:
Veterans will be considered eligible for study participation if the following criteria are met:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David W. Oslin, MD | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coatesville VA Medical Center, Coatesville, PA | Coatesville | Pennsylvania | 19320 | United States | ||
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32108889 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Integreated Care Only | usual care group (Integrated care services only) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Phase |
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| Follow up Period (Aim 2) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Integreated Care Only |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 4 months post randomization |
|
9 months of the trial
Asked at the follow up assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Surgical and medical procedures | Systematic Assessment | Hospitalizations were identified through medical recorder review for dates of admission. We do not have information of the type hospitalization or the reason for hospitalization |
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This study includes data from one VHA medical center, which limits external validity. In addition, the sample size may have limited our power to detect some differences and we relied on self-report measures of occupational functioning.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Oslin, MD | Crescenz VA Medical Center | 215-823-8594 | dave.oslin@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 19, 2016 | Oct 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.](streamdown:incomplete-link) |
| 9 months post randomization |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |
| NOT COMPLETED |
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usual care group (Integrated care services only) |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Depression Severity | PHQ9 is scored 0 to 27 with higher scores being greater distress. A change of 2 or more points is considered clinically relevant. | Mean | Standard Deviation | units on a scale |
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| Work Productivity Lost Score | The WLQ scale ranges = 0 to 25. Higher scores indicate greater dysfunction. There are not specific cut off scores. | Mean | Standard Deviation | units on a scale |
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| 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. | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 9 months post randomization |
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| 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.](streamdown:incomplete-link) | 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. | Posted | Number | marginal benefit in ($) | 9 months post randomization |
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| 2 |
| 139 |
| 7 |
| 139 |
| 0 |
| 139 |
| EG001 | Integreated Care Only | usual care group (Integrated care services only) | 0 | 114 | 10 | 114 | 0 | 114 |
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