Trial Outcomes & Findings for Reducing the Burden of Depression Related Disability (NCT NCT02111811)

Last Updated: 2020-04-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

253 participants

Primary outcome timeframe

4 months post randomization

Results posted on

2020-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	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	Integreated Care Only usual care group (Integrated care services only)
Treatment Phase STARTED	139	114
Treatment Phase COMPLETED	115	96
Treatment Phase NOT COMPLETED	24	18
Follow up Period (Aim 2) STARTED	139	114
Follow up Period (Aim 2) COMPLETED	111	97
Follow up Period (Aim 2) NOT COMPLETED	28	17

Reasons for withdrawal

Reasons for withdrawal
Measure	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	Integreated Care Only usual care group (Integrated care services only)
Treatment Phase Lost to Follow-up	22	18
Treatment Phase Death	2	0
Follow up Period (Aim 2) Lost to Follow-up	26	17
Follow up Period (Aim 2) Death	2	0

Baseline Characteristics

Reducing the Burden of Depression Related Disability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Veterans Work and Health Initiative n=139 Participants Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity	Integreated Care Only n=114 Participants usual care group (Integrated care services only)	Total n=253 Participants Total of all reporting groups
Age, Continuous	46.5 years STANDARD_DEVIATION 11.6 • n=93 Participants	44.8 years STANDARD_DEVIATION 11.6 • n=4 Participants	45.7 years STANDARD_DEVIATION 11.6 • n=27 Participants
Sex: Female, Male Female	17 Participants n=93 Participants	18 Participants n=4 Participants	35 Participants n=27 Participants
Sex: Female, Male Male	122 Participants n=93 Participants	96 Participants n=4 Participants	218 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	60 Participants n=93 Participants	58 Participants n=4 Participants	118 Participants n=27 Participants
Race (NIH/OMB) White	79 Participants n=93 Participants	56 Participants n=4 Participants	135 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Region of Enrollment United States	139 Participants n=93 Participants	114 Participants n=4 Participants	253 Participants n=27 Participants
Depression Severity	14.8 units on a scale STANDARD_DEVIATION 4.8 • n=93 Participants	14.1 units on a scale STANDARD_DEVIATION 4.9 • n=4 Participants	14.5 units on a scale STANDARD_DEVIATION 4.8 • n=27 Participants
Work Productivity Lost Score	12.4 units on a scale STANDARD_DEVIATION 4.9 • n=93 Participants	12.3 units on a scale STANDARD_DEVIATION 4.5 • n=4 Participants	12.3 units on a scale STANDARD_DEVIATION 4.7 • n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Veterans Work and Health Initiative n=115 Participants Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity	Integreated Care Only n=96 Participants usual care group (Integrated care services only)
Improvement in Work Related Disability Post Intervention	-2.1 units on a scale Interval -3.1 to -1.0	-0.09 units on a scale Interval -1.1 to 0.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Veterans Work and Health Initiative n=111 Participants Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity	Integreated Care Only n=97 Participants usual care group (Integrated care services only)
Sustained Improvement in Work Productivity	-3.4 score on a scale Interval -4.5 to -2.3	-.8 score on a scale Interval -1.9 to 0.4

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Veterans Work and Health Initiative n=111 Participants Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity	Integreated Care Only usual care group (Integrated care services only)
The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention.	900 marginal benefit in ($)	—

Adverse Events

Veterans Work and Health Initiative

Serious events: 7 serious events

Other events: 0 other events

Deaths: 2 deaths

Integreated Care Only

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Veterans Work and Health Initiative n=139 participants at risk Integrated care services plus a CBT based intervention focused on work productivity Veterans Work and Health Initiative: CBT based intervention focused on work productivity	Integreated Care Only n=114 participants at risk usual care group (Integrated care services only)
Surgical and medical procedures Hospitalization	5.0% 7/139 • Number of events 7 • 9 months of the trial Asked at the follow up assessments.	8.8% 10/114 • Number of events 10 • 9 months of the trial Asked at the follow up assessments.

Other adverse events

Adverse event data not reported

Additional Information

David Oslin, MD

Crescenz VA Medical Center

Phone: 215-823-8594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place