NCT04504903

Brief Summary

Vocational instability in Veterans with serious mental illness (SMI) is pervasive, costly, and harmful. Over 75% of Veterans with SMI are unemployed, resulting in economic difficulties and trouble meeting basic needs. Overall, among adults with depression, work dysfunction results in a 36 to 51 billion dollar loss annually. Unemployed Veterans with SMI also suffer major health consequences, including a more severe course of illness and poor recovery over time, leading to increased inpatient and emergency service use. The WORKWELL study will synergistically address these deficits in health, recovery, and work functioning by testing the Cognitive Behavioral Therapy for Work Success (CBTw) intervention. Using a pragmatic design, this project will address work as a major social determinant of health and close the health disparity gap among people with SMI. Further, through promotion of work and healthy thinking, CBTw holds promise to reduce risk of suicide among vulnerable veterans with SMI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
294

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

August 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

April 1, 2026

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

3.7 years

First QC Date

August 4, 2020

Results QC Date

January 23, 2026

Last Update Submit

March 11, 2026

Conditions

Keywords

Rehabilitation, Vocational

Outcome Measures

Primary Outcomes (3)

  • Total Weeks Worked in Competitive Jobs

    Mean number of weeks worked in competitive jobs. Competitive jobs are regular jobs open to all that pay at least minimum wage. More total weeks worked in competitive jobs is indicative of a positive outcome.

    Baseline to 3 months

  • Total Weeks Worked in Competitive Jobs

    Mean number of weeks worked in competitive jobs.

    3 to 6 Months

  • Total Weeks Worked in Competitive Jobs

    Mean number of weeks worked in competitive jobs.

    6 to 9 months

Secondary Outcomes (4)

  • Short Employment Hope Scale (EHS-14)

    baseline to 9 months

  • Recovery Assessment Scale (RAS)

    baseline to 9 months

  • Scale for Suicidal Ideation Change

    baseline to 9 months

  • Cognitive Behavioral Therapy for Work Success (CBTw) Fidelity

    12 weeks (during the CBTw intervention period)

Study Arms (2)

Cognitive Behavioral Therapy For Work Success (CBTw)

EXPERIMENTAL

Veterans will participate in 12 weekly group sessions to discuss thoughts, feelings, and behaviors that promote work success in the community

Behavioral: Cognitive Behavioral Therapy For Work Success (CBTw)

Psychoeducation

ACTIVE COMPARATOR

Veterans in the control group will participate in 12 weekly group sessions in which they will learn more about their mental health conditions.

Behavioral: Psychoeducation

Interventions

PsychoeducationBEHAVIORAL

Veterans will go to 12 weekly group sessions and will learn more information about their mental health conditions. Psychoeducation modules are from the Illness Management and Recovery program.

Psychoeducation

Veterans will go to 12 weekly group sessions and will learn healthy thinking about work, positive behavioral coping related to work, and will form a work success plan based on their work goals.

Cognitive Behavioral Therapy For Work Success (CBTw)

Eligibility Criteria

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

You may qualify if:

  • Unemployment, defined as no current participation in a competitive job
  • A competitive work goal, which denotes a goal of a regular job in the community that pays at least minimum wage
  • Presence of a serious mental illness including one or more of the following conditions:
  • major depression
  • bipolar disorders
  • schizophrenia
  • schizoaffective disorder
  • posttraumatic stress disorder (PTSD)
  • Currently enrolled in and receiving VA vocational rehabilitation services

You may not qualify if:

  • Previous participation in cognitive behavioral therapy intervention geared toward work
  • Presence of a severe medical or cognitive impairment that will prevent participation in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-5000, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

St. Louis VA Medical Center John Cochran Division, St. Louis, MO

St Louis, Missouri, 63106, United States

Location

Related Publications (2)

  • Kukla M, McGuire AB, Weber KC, Hatfield J, Henry N, Kulesza E, Rollins AL. An Investigation of Employment Hope as a Key Factor Influencing Perceptions of Subjective Recovery among Adults with Serious Mental Illness Seeking Community Work. Behav Sci (Basel). 2024 Mar 19;14(3):246. doi: 10.3390/bs14030246.

  • Kukla ME, Rollins AL, Weber K, Hatfield J, Wu W, Faith L. A., Carter J. L., Wiesepape C, Connors MJ, Wahle SS, Pashka NJ, McGuire AB. A Pragmatic Randomized Controlled Trial Investigating Work Enhanced Cognitive Behavioral Therapy for People with Serious Mental Illness (WORKWELL): Background, Design, and Baseline Outcomes. Journal of Vocational Rehabilitation. 2025 Nov 1; 63(3):299-311, DOI: 10.1177/10522263251376530

    RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

There are no limitations to this study.

Results Point of Contact

Title
Dr. Marina Kukla
Organization
Department of Veterans Affairs

Study Officials

  • Marina Elizabeth Kukla, PhD MS BS

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research personnel conducting outcomes assessments will be blinded to condition assignment
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Unemployed participants with serious mental illness will be randomized to receive group-based cognitive behavioral therapy geared toward improving competitive work outcomes or a time and format matched psychoeducation intervention
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2020

First Posted

August 7, 2020

Study Start

January 1, 2021

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

April 1, 2026

Results First Posted

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
The data will become available once the study team completes all analyses.
Access Criteria
The Research Service will evaluate individual requests.

Locations