Restricted accessResearch articleFirst published online 2025-11
A Pragmatic Randomized Controlled Trial Investigating Work Enhanced Cognitive Behavioral Therapy for People with Serious Mental Illness (WORKWELL): Background,Design,and Baseline Outcomes
Employment is a powerful social determinant of health, and dysfunction in this area is pervasive among veterans with serious mental illness (SMI), despite implementation of evidence-based employment services by the US Department of Veterans Affairs. Recently, cognitive and behavioral work barriers have been identified.
Objective
The Cognitive Behavioral Therapy for Work Success intervention (CBTw) was developed, demonstrating early promise in improving work and psychosocial outcomes among Veterans with SMI. WORKWELL is a hybrid Type I, three site randomized controlled trial seeking to rigorously test the effectiveness and implementation of CBTw into VA employment services.
Methods
WORKWELL seeks to enroll 276 unemployed veterans with SMI receiving VA employment services, randomizing them to 12 weeks of group based CBTw or a psychoeducation control. Study interventions will be implemented by VA vocational rehabilitation counselors.
Outcomes
Measured at baseline, post-treatment, 6, 9, and 12 months, the primary Veteran outcome is competitive work. Secondary outcomes include health, psychosocial, and suicidality factors. Inpatient service utilization will be assessed, and exploratory employment outcomes will be measured at 12 months to capture outcomes that may take longer to emerge.
Conclusions
Guided by the RE-AIM framework, factors needed to rapidly implement CBTw across the VA will be captured.
AbrahamK. M.ChangM.-U. M.VanT.ResnickS. G.ZivinK. (2021). Employment after vocational rehabilitation predicts decreased health care utilization in veterans with mental health diagnoses. Military Medicine, 186(9–10), 850–857. https://doi.org/10.1093/milmed/usab113
2.
AbrahamK. M.YosefM.ResnickS. G.ZivinK. (2017). Competitive employment outcomes among veterans in VHA therapeutic and supported employment services programs. Psychiatric Services, 68(9), 938–946. https:/doi.org/10.1176/appi.ps.201600412
3.
Alvarez-JimenezM.GleesonJ.HenryL.HarriganS.HarrisM.KillackeyE.BendallS.AmmingerG.YungA.HerrmanH. (2012). Road to full recovery: Longitudinal relationship between symptomatic remission and psychosocial recovery in first-episode psychosis over 7.5 years. Psychological Medicine, 42(3), 595–606. https://doi.org/10.1017/S0033291711001504
4.
AverillJ. B. (2002). Matrix analysis as a complementary analytic strategy in qualitative inquiry. Qualitative Health Research, 12(6), 855–866. https://doi.org/10.1177/104973230201200611
5.
BeckA. T.BrownG. K.SteerR. A. (1997). Psychometric characteristics of the scale for suicide ideation with psychiatric outpatients. Behaviour Research and Therapy, 35(11), 1039–1046. https://doi.org/10.1016/S0005-7967(97)00073-9
6.
BeebeJ. (2001). Rapid assessment process: An introduction. AltaMira Press.
7.
BenachJ.VivesA.AmableM.VanroelenC.TarafaG.MuntanerC. (2014). Precarious employment: understanding an emerging social determinant of health. Annual review of public health, 35(1), 229–253. https://doi.org/10.1146/annurev-publhealth-032013-182500
8.
BiegelD. E.StevensonL. D.BeimersD.RonisR. J.BoyleP. (2009). Predictors of competitive employment among consumers with co-occurring mental and substance use disorders. Research on Social Work Practice, 20(2), 191–201. https://doi.org/10.1177/1049731509333373
9.
BlosnichJ. R.MontgomeryA. E.DichterM. E.GordonA. J.KavalieratosD.TaylorL.KettererB.BossarteR. M. (2020). Social determinants and military veterans’ suicide ideation and attempt: A cross-sectional analysis of electronic health record data. Journal of General Internal Medicine, 35(6), 1759–1767. https://doi.org/10.1007/s11606-019-05447-z
10.
BondG. R.CampbellK.DrakeR. E. (2012). Standardizing measures in four domains of employment outcomes for individual placement and support. Psychiatric Services, 63(8), 751–757. https://doi.org/10.1176/appi.ps.201100270
11.
BondG. R.KuklaM. (2011). Is job tenure brief in individual placement and support (IPS) employment programs?Psychiatric Services, 62(8), 950–953. https://doi.org/10.1176/ps.62.8.pss6208_0950
12.
CampbellK.BondG. R.DrakeR. E.McHugoG. J.XieH. (2010). Client predictors of employment outcomes in high-fidelity supported employment: A regression analysis. The Journal of Nervous and Mental Disease, 198(8), 556–563. https://doi.org/10.1097/NMD.0b013e3181ea1e53
13.
CharmazK. (2006). Constructing grounded theory: A practical guide through qualitative analysis. Sage Publications.
14.
CorbièreM.LanctôtN.SanquirgoN.LecomteT. (2009). Evaluation of self-esteem as a worker for people with severe mental disorders. Journal of Vocational Rehabilitation, 30(2), 87–98. https://doi.org/10.3233/JVR-2009-0455
15.
CorbièreM.VillottiP.BerbicheD.LecomteT. (2024). Predictors of job tenure for people with a severe mental illness, enrolled in supported employment programs. Psychiatric Rehabilitation Journal, 47(1), 64–72. https://doi.org/10.1037/prj0000589
16.
CorriganP. W.GiffortD.RashidF.LearyM.OkekeI. (1999). Recovery as a psychological construct. Community Mental Health Journal, 35(3), 231–239. https://doi.org/10.1023/A:1018741302682
Davis, L. L., Kyriakides, T. C., Suris, A., Ottomanelli, L., Drake, R. E., Parker, P. E., Mueller, L., Resnick, S. G., Toscano, R., Blansett, C. M., McCall, K. P., & Huang, G. D. (2018). Veterans individual placement and support towards advancing recovery: Methods and baseline clinical characteristics of a multisite study. Psychiatric Rehabilitation Journal, 41(1), 55–66. https://doi.org/10.1037/prj0000250
19.
DrakeR. E.BondG. R. (2023). Individual placement and support: History, current status, and future directions. Psychiatry and Clinical Neurosciences Reports, 2(3), e122. https://doi.org/10.1002/pcn5.122
20.
DrakeR. E.BondG. R.MascayanoF. (2023). Modification of the individual placement and support model of supported employment. Psychiatric Services, 74(6), 656–658. https://doi.org/10.1176/appi.ps.20220484
21.
DunnE. C.WewiorskiN. J.RogersE. S. (2008). The meaning and importance of employment to people in recovery from serious mental illness: Results of a qualitative study. Psychiatric Rehabilitation Journal, 32(1), 59–62. https://doi.org/10.2975/32.1.2008.59.62
22.
ElbogenE. B.JohnsonS. C.WagnerH. R.NewtonV. M.BeckhamJ. C. (2012). Financial well-being and postdeployment adjustment among Iraq and Afghanistan war veterans. Military Medicine, 177(6), 669–675. https://doi.org/10.7205/MILMED-D-11-00388
23.
ElbogenE. B.MolloyK.WagnerH. R.KimbrelN. A.BeckhamJ. C.Van MaleL.LeinbachJ.BradfordD. W. (2020). Psychosocial protective factors and suicidal ideation: Results from a national longitudinal study of veterans. Journal of Affective Disorders, 260(2020), 703–709. https://doi.org/10.1016/j.jad.2019.09.062
24.
GibbonsB. J.SalkeverD. S. (2019). Working with a severe mental illness: Estimating the causal effects of employment on mental health status and total mental health costs. Administration and Policy in Mental Health and Mental Health Services Research, 46(4), 474–487. https://doi.org/10.1007/s10488-019-00926-1
25.
GranholmE.HoldenJ.LinkP. C.McQuaidJ. R. (2014). Randomized clinical trial of cognitive behavioral social skills training for schizophrenia: Improvement in functioning and experiential negative symptoms. Journal of Consulting and Clinical Psychology, 82(6), 1173–1185. https://doi.org/10.1037/a0037098
26.
HamiltonA. B.CohenA. N.GloverD. L.WhelanF.ChemerinskiE.McNagnyK. P.MullinsD.ReistC.SchubertM.YoungA. S. (2013). Implementation of evidence-based employment services in specialty mental health. Health Services Research, 48(6pt2), 2224–2244. https://doi.org/10.1111/1475-6773.12115
27.
HarrisP. A.TaylorR.ThielkeR.PayneJ.GonzalezN.CondeJ. G. (2009). Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics, 42(2), 377–381. https://doi.org/10.1016/j.jbi.2008.08.010
28.
HofmannS. G.WuJ. Q.BoettcherH. (2014). Effect of cognitive-behavioral therapy for anxiety disorders on quality of life: A meta-analysis. Journal of Consulting and Clinical Psychology, 82(3), 375–391. https://doi.org/10.1037/a0035491
29.
HongP. Y. P.HongR.ChoiS.HodgeD. R. (2021). Examining psychological self-sufficiency among low-income jobseekers with mental health barriers. Community Mental Health Journal, 57(1), 178–188. https://doi.org/10.1007/s10597-020-00630-7
30.
HongP. Y. P.ChoiS.PolaninJ. R. (2014). A multisample confirmatory factor analysis of the short employment hope scale (EHS-14). Journal of Social Service Research, 40(3), 339–352. https://doi.org/10.1080/01488376.2014.901277
31.
KernanW. N.ViscoliC. M.MakuchR. W.BrassL. M.HorwitzR. I. (1999). Stratified randomization for clinical trials. Journal of Clinical Epidemiology, 52(1), 19–26. https://doi.org/10.1016/S0895-4356(98)00138-3
32.
KuklaM.BondG. R.XieH. (2012). A prospective investigation of work and nonvocational outcomes in adults with severe mental illness. The Journal of Nervous and Mental Disease, 200(3), 214–222. https://doi.org/10.1097/NMD.0b013e318247cb29
33.
KuklaM.BonfilsK. A.SalyersM. P. (2015). Factors impacting work success in veterans with mental health disorders: A veteran-focused mixed methods pilot study. Journal of Vocational Rehabilitation, 43(1), 51–66. https://doi.org/10.3233/JVR-150754
34.
KuklaM.McGuireA. B.SalyersM. P. (2016a). Barriers and facilitators related to work success for veterans in supported employment: A nationwide provider survey. Psychiatric Services, 67(4), 412–417. https://doi.org/10.1176/appi.ps.201500108
35.
KuklaM.SalyersM. P.StrasburgerA. M.Johnson-KwochkaA.AmadorE.LysakerP. H. (2019). Work-focused cognitive behavioral therapy to complement vocational services for people with mental illness: Pilot study outcomes across a 6-month posttreatment follow-up. Psychiatric Rehabilitation Journal, 42(4), 366–371. https://doi.org/10.1037/prj0000365
36.
KuklaM.StrasburgerA. M.LysakerP. H. (2016b). A cognitive behavioral therapy intervention targeting competitive work outcomes for persons with mental illness. Psychiatr Serv, 67(6), 697. https://doi.org/10.1176/appi.ps.670504
37.
KuklaM.StrasburgerA. M.SalyersM. P.RattrayN. A.LysakerP. H. (2017). Subjective experiences of the benefits and key elements of a cognitive behavioral therapy focused on community work outcomes in persons with mental illness. Journal of Nervous and Mental Disease, 205(1), 66–73. https://doi.org/10.1097/NMD.0000000000000601
38.
KuklaM.StrasburgerA. M.SalyersM. P.RollinsA. L.LysakerP. H. (2018). A pilot test of group based cognitive behavioral therapy to augment vocational services for persons with serious mental illness: Feasibility and competitive work outcomes. The Journal of Nervous and Mental Disease, 206(5), 310–315. https://doi.org/10.1097/NMD.0000000000000796
39.
KuklaM.StrasburgerA. M.SalyersM. P.RollinsA. L.LysakerP. H. (2021). Psychosocial outcomes of a pilot study of work-tailored cognitive behavioral therapy intervention for adults with serious mental illness. Journal of Clinical Psychology, 77(3), 488–495. https://doi.org/10.1002/jclp.23048
40.
LucianoA.BondG. R.DrakeR. E. (2014). Does employment alter the course and outcome of schizophrenia and other severe mental illnesses? A systematic review of longitudinal research. Schizophrenia Research, 159(2), 312–321. https://doi.org/10.1016/j.schres.2014.09.010
41.
LysakerP. H.DavisL. W.BrysonG. J.BellM. D. (2009). Effects of cognitive behavioral therapy on work outcomes in vocational rehabilitation for participants with schizophrenia spectrum disorders. Schizophr Res, 107(2–3), 186–191. https://doi.org/S0920-9964(08)00482-9. [pii] 10.1016/j.schres.2008.10.018
42.
MarroneJ.SwarbrickM. A. (2020). Long-Term unemployment: A social determinant underaddressed within community behavioral health programs. Psychiatric Services, 71(7), 745–748. https://doi.org/10.1176/appi.ps.201900522
43.
MilneD.ClaydonT.BlackburnI.-M.JamesI.SheikhA. (2001). Rationale for a new measure of competence in therapy. Behavioural and Cognitive Psychotherapy, 29(01), 21–33. https://doi.org/10.1017/S1352465801001047
44.
MueserK. T.MeyerP. S.PennD. L.ClancyR.ClancyD. M.SalyersM. P. (2006). The illness management and recovery program: Rationale, development, and preliminary findings. Schizophrenia Bulletin, 32(suppl_1), S32–S43. https://doi.org/10.1093/schbul/sbl022
45.
MuthénL. K.MuthénB. O. (2002). How to use a monte carlo study to decide on sample size and determine power. Structural Equation Modeling, 9(4), 599–620. https://doi.org/10.1207/S15328007SEM0904_8
46.
NarrowW. E.ClarkeD. E.KuramotoS. J.KraemerH. C.KupferD. J.GreinerL.RegierD. A. (2013). DSM-5 field trials in the United States and Canada, part III: Development and reliability testing of a cross-cutting symptom assessment for DSM-5. American Journal of Psychiatry, 170(1), 71–82. https://doi.org/10.1176/appi.ajp.2012.12071000
47.
OttomanelliL.GoetzL. L.SurisA.McGeoughC.SinnottP. L.ToscanoR.BarnettS. D.CipherD. J.LindL. M.DixonT. M. (2012). Effectiveness of supported employment for veterans with spinal cord injuries: Results from a randomized multisite study. Archives of Physical Medicine and Rehabilitation, 93(5), 740–747. https://doi.org/10.1016/j.apmr.2012.01.002
48.
R Core Team. (2019). R: A language and environment for statistical computing. R Foundation for Statistical Computing.
49.
RobertsG. A. (2000). Narrative and severe mental illness: What place do stories have in an evidence-based world?Advances in Psychiatric Treatment, 6(6), 432–441. https://doi.org/10.1192/apt.6.6.432
50.
TwamleyE. W.NarvaezJ. M.BeckerD. R.BartelsS. J.JesteD. V. (2008). Supported employment for middle-aged and older people with schizophrenia. American Journal of Psychiatric Rehabilitation, 11(1), 76–89. https://doi.org/10.1080/15487760701853326
51.
Van RijnR. M.CarlierB. E.SchuringM.BurdorfA. (2016). Work as treatment? The effectiveness of re-employment programmes for unemployed persons with severe mental health problems on health and quality of life: A systematic review and meta-analysis. Occup Environ Med, 73(4), 275–279. https://doi.org/10.1136/oemed-2015-103121
52.
WareJ. E., Jr.KosinskiM.KellerS. D. (1996). A 12-item short-form health survey: Construction of scales and preliminary tests of reliability and validity. Medical Care, 34(3), 220–233. https://doi.org/10.1097/00005650-199603000-00003
53.
WaynorW. R.PrattC. W. (2011). Barriers to vocational effectiveness in ACT: Staff perspectives. Journal of the American Psychiatric Nurses Association, 17(1), 72–79. https://doi.org/10.1177/1078390310394844
54.
WilliamsA. E.FosseyE.CorbièreM.PaluchT.HarveyC. (2016). Work participation for people with severe mental illnesses: An integrative review of factors impacting job tenure. Australian Occupational Therapy Journal, 63(2), 65–85. https://doi.org/10.1111/1440-1630.12237
55.
ZivinK.BohnertA. S.MezukB.IlgenM. A.WelshD.RatliffS.MillerE. M.ValensteinM.KilbourneA. M. (2011). Employment status of patients in the VA health system: Implications for mental health services. Psychiatric Services, 62(1), 35–38. https://doi.org/10.1176/ps.62.1.pss6201_0035
