NCT01918774

Brief Summary

In 2010, 11.5% of all Gulf War-II Veterans were unemployed; that figure rose to 15.2% in January 2011 and continues to grow as the number of Veterans from recent wars increases. The prevalence of mental illness among Veterans is also notable; estimates range from 31% to nearly 37% for any psychiatric disorder, and over half of these Veterans are diagnosed with more than one psychiatric condition. In addition, empirical evidence suggests that some mental disorders are more prevalent in Veterans than in the general population. Linking unemployment and mental illness, a recent study found that 65% of Veterans using VA healthcare were unemployed, and compared to employed Veterans, the unemployed were more likely to have depression, bipolar disorder, post traumatic stress disorder (PTSD), schizophrenia, or substance use disorders. Vocational dysfunction was reported most often in disabled Veterans with schizophrenia, PTSD, and substance use disorders. Not surprisingly, this study also found that unemployed Veterans had significantly lower income than employed persons. Similarly, a large study focusing specifically on Veterans with PTSD concluded that vocational dysfunction is a notable problem among this group, as they were significantly less likely to be employed after participating in VA work programs compared with participants without the disorder. Because most individuals with mental illness desire to work in regular competitive employment, the nationwide problem of unemployment among Veterans with mental illness is particularly troubling. The VA is addressing this need by implementing supported employment (SE), a psychiatric rehabilitation approach that provides individual vocational assistance to Veterans with mental illness. While the SE model is empirically validated and SE programs have been shown to achieve partial success in improving employment outcomes, a sizable proportion of individuals, 40% or more, remain unemployed. A further challenge is job retention; Veterans with mental illness who obtain jobs frequently struggle to maintain them long-term. Even in the context of high quality, evidence-based vocational services, most studies show only modest job retention of a few months, and consequently, frequent job losses and inconsistent vocational functioning remain a substantial and unsolved problem. Rationale: Cognitive behavioral therapy (CBT) effectively reduces symptoms across a range of psychiatric conditions; however, its benefit to functioning remains less well understood. Work functioning has received little empirical attention in the CBT domain. Despite research evidence suggesting that maladaptive thoughts about oneself and expectations about the ability to work interfere with work success, no CBT programs have been developed specifically targeting vocational themes with the goal of improving competitive work outcomes. Further, a recent paper outlined needed avenues of future study in the SE domain; Drake and Bond (2011) state that cognitive strategies may be a fruitful area to develop to help "nonresponder" consumers with mental illness who struggle with vocational dysfunction despite high quality vocational assistance. The goal of the current project is to address this gap and the serious problem of unemployment in Veterans with mental illness by pilot testing the CBT for work success program (CBTw) and assessing key employment outcomes before and after the intervention, and six months after conclusion of the intervention. Specific Aims: Aim 1: Test the preliminary efficacy of the CBTw program on key Veteran employment and psychosocial outcomes utilizing a pre/post design. Aim 2: Further assess the feasibility of the program, including recruitment, retention rates, and program participation rates. Aim 3: Gauge effect sizes in preparation for a larger randomized controlled trial examining the effectiveness of the CBT program in routine practice settings

Trial Health

87
On Track

Trial Health Score

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

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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 5, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 8, 2013

Completed
2.5 years until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 19, 2019

Completed
Last Updated

August 19, 2019

Status Verified

July 1, 2019

Enrollment Period

2.5 years

First QC Date

August 5, 2013

Results QC Date

March 12, 2019

Last Update Submit

July 12, 2019

Conditions

Keywords

UnemploymentCognitive Behavioral TherapyMental Disorders

Outcome Measures

Primary Outcomes (2)

  • Change in Competitive Employment

    Competitive employment is standard in studies of employment in persons with mental illness and will include change in the total number of weeks worked in competitive jobs between baseline and the 6 month follow-up point.

    Change from baseline competitive employment to 6 month follow up competitive employment

  • Number of Participants With Steady Competitive Work Attainment

    Steady competitive work attainment, defined as working at least half the follow up period, will be assessed at the 6 month follow up.

    6 month follow up

Secondary Outcomes (10)

  • Work Effectiveness

    baseline and 12 week follow up scores

  • Positive and Negative Syndrome Scale (PANSS)

    baseline, 12 week follow up

  • Beck Depression Inventory (BDI-II)

    baseline, post intervention (12 weeks)

  • Beck Anxiety Inventory (BAI)

    baseline, 12 week follow up

  • Work Related Self-efficacy Scale

    baseline, 12 week follow up

  • +5 more secondary outcomes

Study Arms (1)

Cognitive behavior therapy for work success

OTHER

Fifty participants will take part in the 12 week CBTw program. All participants will receive standard SE services during the study. The longitudinal design will consist of assessments of competitive employment outcomes, important psychosocial outcomes, and background and demographic variables at baseline and at two follow-up periods' immediately following the conclusion of the CBTw program and six months after the conclusion of the program.

Behavioral: Cognitive behavior therapy for work success (CBTw)

Interventions

The CBTw program includes 12 sessions that are delivered in a weekly one-hour group format. Sessions focused on identifying and modifying maladaptive thoughts related to work, enhancing self efficacy and beliefs in one's ability to succeed at work, identifying and addressing personal barriers to work, and increasing beneficial coping strategies that can be applied across employment settings, including during the job search phase and working on the job. The intervention is tailored toward both employed and unemployed persons seeking community work. Session content includes the following modules: Introduction-Work goals and work story; CBT model and work; Thinking about work; Barriers to work; Coping with stress and anxiety; Coping with anger and difficult emotions; Communication at work; Dealing effectively with people at work; Managing work success; Personal work success plan.

Cognitive behavior therapy for work success

Eligibility Criteria

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

You may qualify if:

  • Participants include Veterans who are receiving individualized vocational services at an urban Midwestern VA medical center.
  • participants may be currently working in the community or unemployed and searching for work

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (6)

  • Kukla M, McGuire AB, Salyers MP. Rural and urban supported employment programs in the Veterans Health Administration: Comparison of barriers and facilitators to vocational achievement for veterans experiencing mental illnesses. Psychiatr Rehabil J. 2016 Jun;39(2):129-36. doi: 10.1037/prj0000184. Epub 2016 Apr 7.

    PMID: 27054902BACKGROUND
  • Kukla M, McGuire AB, Salyers MP. Barriers and Facilitators Related to Work Success for Veterans in Supported Employment: A Nationwide Provider Survey. Psychiatr Serv. 2016 Apr 1;67(4):412-7. doi: 10.1176/appi.ps.201500108. Epub 2015 Dec 15.

  • Kukla M, Strasburger AM, Lysaker PH. A CBT Intervention Targeting Competitive Work Outcomes for Persons With Mental Illness. Psychiatr Serv. 2016 Jun 1;67(6):697. doi: 10.1176/appi.ps.670504. No abstract available.

  • Kukla M, Strasburger AM, Salyers MP, Rattray NA, Lysaker PH. Subjective Experiences of the Benefits and Key Elements of a Cognitive Behavioral Intervention Focused on Community Work Outcomes in Persons With Mental Illness. J Nerv Ment Dis. 2017 Jan;205(1):66-73. doi: 10.1097/NMD.0000000000000601.

  • Kukla M, Strasburger AM, Salyers MP, Rollins AL, Lysaker PH. A Pilot Test of Group Based Cognitive Behavioral Therapy to Augment Vocational Services for Persons With Serious Mental Illness: Feasibility and Competitive Work Outcomes. J Nerv Ment Dis. 2018 May;206(5):310-315. doi: 10.1097/NMD.0000000000000796.

  • Kukla M, Salyers MP, Strasburger AM, Johnson-Kwochka A, Amador E, Lysaker PH. Work-focused cognitive behavioral therapy to complement vocational services for people with mental illness: Pilot study outcomes across a 6-month posttreatment follow-up. Psychiatr Rehabil J. 2019 Dec;42(4):366-371. doi: 10.1037/prj0000365. Epub 2019 May 9.

MeSH Terms

Conditions

Mental Disorders

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Limitations and Caveats

Limitations of the study include a small sample size and an open trial design.

Results Point of Contact

Title
Marina Kukla
Organization
Richard L. Roudebush VA Medical Center

Study Officials

  • Marina Elizabeth Kukla, BS MS PhD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2013

First Posted

August 8, 2013

Study Start

February 1, 2016

Primary Completion

July 31, 2018

Study Completion

September 30, 2018

Last Updated

August 19, 2019

Results First Posted

August 19, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations