Reducing the Burden of Depression Related Disability

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT02111811
Collaborator
Tufts Medical Center (Other)
253
2
2
43.4
126.5
2.9

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
  • Other: Veterans Work and Health Initiative
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

Study Type:
Interventional
Actual Enrollment :
253 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Reducing the Burden of Depression on Employment: Improving Function and Work
Actual Study Start Date :
May 19, 2014
Actual Primary Completion Date :
Dec 30, 2017
Actual Study Completion Date :
Dec 30, 2017

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

  1. 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

  1. 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.

  2. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

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.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02111811
Other Study ID Numbers:
  • D1132-R
  • I01RX001132-01A1
First Posted:
Apr 11, 2014
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

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

1. Primary Outcome
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
2. Secondary Outcome
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
3. Secondary Outcome
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

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.

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
Email dave.oslin@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT02111811
Other Study ID Numbers:
  • D1132-R
  • I01RX001132-01A1
First Posted:
Apr 11, 2014
Last Update Posted:
Apr 28, 2020
Last Verified:
Apr 1, 2020