NCT02111811

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
253

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable depression

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 11, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 19, 2014

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

April 8, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

3.6 years

First QC Date

March 31, 2014

Results QC Date

October 2, 2019

Last Update Submit

April 16, 2020

Conditions

Depression

Keywords

DepressionTreatment OutcomeDelivery of Healthcare, IntegratedEmploymentRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Sustained Improvement in Work Productivity

    9 months post randomization

  • The Outcome is the Return on Investment (ROI) Obtained From Implementing the V-WHI Experimental Intervention.

    9 months post randomization

Study Arms (2)

Be Well At Work intervention + IC

EXPERIMENTAL

CBT based intervention focused on work productivity plus integrated care as usual

Other: Veterans Work and Health Initiative

Integrated Care Only

NO INTERVENTION

usual care group (Behavioral Health lab care at the PVAMC)

Interventions

Veterans Work and Health InitiativeOTHER

CBT based intervention focused on work productivity

Be Well At Work intervention + IC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans will be considered eligible for study participation if the following criteria are met:
  • 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

You may not qualify if:

  • Non-English speaking or reading
  • bipolar disorder
  • psychosis
  • and/or planning to take maternity leave at any point in the next nine months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Coatesville VA Medical Center, Coatesville, PA

Coatesville, Pennsylvania, 19320, United States

Location

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 32108889RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Limitations and 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.

Results Point of Contact

Title
David Oslin, MD
Organization
Crescenz VA Medical Center
dave.oslin@va.gov
215-823-8594

Study Officials

  • David W. Oslin, MD

    Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2014

First Posted

April 11, 2014

Study Start

May 19, 2014

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

April 28, 2020

Results First Posted

April 8, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

US(2)