SchizophreniaBESTVetNCT01992913

Building Employment Skills Through Therapy for Veterans

A study testing integrated Cognitive Behavioral Therapy and Computerized cognitive remediation (CCR) in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: integrated Cognitive Behavioral Therapy and Computerized cognitive remediation (CCR)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 1 siteUnited States
Study dates: 12 Jun 2015to 30 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of DSM-IV schizophrenia or schizoaffective disorder (SCID)
Severe/extreme functional disability [World Health Organization Disability Assessment Scale (WHODAS) score > 50]
Clinical stability (as per primary mental health provider)
Receiving treatment at the Veterans Administration
Minimal engagement in psychiatric rehabilitation services (just psychiatrist and therapist/case management in the last 6 months)
Eligible for and willing to be enrolled in Supported Employment program

Show all 9Show fewer

Age 18 to 65
Proficient in English
Able to give informed consent

Who cannot join

Neurologic disease or damage that would make the diagnosis of schizophrenia questionable
Current opioid or stimulant dependence (SCID)
Not appropriate due to safety concerns (based on risk assessment)

Trial locations and contacts

1 site in 1 country.

United States1 site

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia

Schizophrenia/Schizoaffective Disorder is associated with serious problems with cognitive skills, social skills, and functional skills (like employment). There is a new form of cognitive behavioral therapy called integrated cognitive behavioral therapy (iCBT) that specifically addresses the cognitive, social, and functional deficits of schizophrenia/schizoaffective disorder. This study compared iCBT to the usual care (UC) that Veteran's receive. The investigators compared iCBT to UC in subjects with schizophrenia/schizoaffective disorder who are enrolled in a Supported Employment (SE) program, and evaluate whether iCBT is more helpful in improving job attainment, and other areas of functioning, both right after treatment, and 6 months after the end of treatment.

Read the detailed description

The objective of the current study was to evaluate whether integrated cognitive behavior therapy (iCBT) can improve engagement and success in an existing Supported Employment (SE) program among the most functionally disabled patients with schizophrenia/schizoaffective disorder. The iCBT condition also included computerized cognitive remediation. The primary specific aim was to determine whether iCBT will significantly improve work outcomes at post-treatment to a greater extent than Usual Care (UC) in low functioning patients with schizophrenia/schizoaffective disorder who join the SE program. The secondary aims were to evaluate the whether iCBT will significantly improve work outcomes at 6 month follow-up relative to UC, and whether iCBT will improve functional outcomes post-treatment and at follow-up relative to UC in subjects who join the SE program.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: integrated Cognitive Behavioral Therapy, Usual Care, Computerized cognitive remediation (CCR)
Keywords: Schizophrenia, Cognitive Behavioral Therapy, Cognition, Vocational Rehabilitation, Supported Employment, Schizoaffective Disorder
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

integrated Cognitive Behavioral TherapyBehavioural
Also called iCBT
Novel CBT paradigm for schizophrenia/schizoaffective disorder
Usual CareOther
Also called UC
The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition)
Computerized cognitive remediation (CCR)Behavioural
Also called CCR
Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.

Study groups in NCT01992913
Study group	Role	What they receive
integrated CBT with computerized cognitive remediation	Experimental	integrated CBT with computerized cognitive remediation Receives: Behavioral: integrated Cognitive Behavioral Therapy; Behavioral: Computerized cognitive remediation (CCR)
Treatment As Usual	Other	Treatment As Usual Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Workforce Participation Measure - Total Number of Jobs Attained
Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end)
Measured: Baseline to post-treatment (18-months)
Overall Job Attainment Proportion
This is the proportion of participants, by group, that attained at least one job during the active portion of the study.
Measured: Study start through 18 months of the active portion of the study.
Job Participant Composite-hours Worked
This is a composite of hours work per week X number of weeks worked, in each assessment period.
Measured: Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start.

Secondary outcomes (2)

Work Behavior Inventory
Measure completed by the supported employment specialist that evaluates work quality in an employment setting, based on the job supervisor's report, using the overall impression rating, ranging from 1 (consistently needing improvement) to 5 (consistently superior performance). Only the job supervisor's was used, rather than other options possible with the measure.
Measured: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Specific Levels of Functioning (SLOF)
This is measure designed to assess individual social, work, and interpersonal functioning of individuals with severe mental illness. The possible total score ranges from 30 - 150 with higher scores representing higher levels of functioning.
Measured: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201530 Sep 2020

First posted25 Nov 2013 (estimated)
Study start12 Jun 2015
Primary completion30 Sep 2020
Study completion30 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01992913
Sponsor's protocol ID: D1157-R
Acronym: BESTVet
Status last verified: Dec 2024
First submitted: 1 Nov 2013
Last updated: 22 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Integrated Cognitive Behavior Therapy to Improve Work Outcomes in Schizophrenia
ClinicalTrials.gov ID: NCT01992913
Acronym / sponsor ID: BESTVet / D1157-R
Conditions: Schizophrenia, Schizoaffective Disorder
Keywords: Schizophrenia, Cognitive Behavioral Therapy, Cognition, Vocational Rehabilitation, Supported Employment, Schizoaffective Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 67 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 12 Jun 2015 (actual)
Primary completion: 30 Sep 2020 (actual)
Study completion: 30 Sep 2020 (actual)
First posted: 25 Nov 2013 (estimated)
Results: Posted 22 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
integrated CBT with computerized cognitive remediation	Experimental	Behavioral: integrated Cognitive Behavioral Therapy, Behavioral: Computerized cognitive remediation (CCR)integrated CBT with computerized cognitive remediation
Treatment As Usual	Other	Other: Usual CareTreatment As Usual

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Diagnosis of DSM-IV schizophrenia or schizoaffective disorder (SCID)
Severe/extreme functional disability [World Health Organization Disability Assessment Scale (WHODAS) score > 50]
Clinical stability (as per primary mental health provider)
Receiving treatment at the Veterans Administration
Minimal engagement in psychiatric rehabilitation services (just psychiatrist and therapist/case management in the last 6 months)

Key exclusion criteria (3 listed)

Neurologic disease or damage that would make the diagnosis of schizophrenia questionable
Current opioid or stimulant dependence (SCID)
Not appropriate due to safety concerns (based on risk assessment)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
integrated Cognitive Behavioral TherapyAlso: iCBTNovel CBT paradigm for schizophrenia/schizoaffective disorder	Behavioural	integrated CBT with computerized cognitive remediation
Usual CareAlso: UCThe usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition)	Other	Treatment As Usual
Computerized cognitive remediation (CCR)Also: CCRPart of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.	Behavioural	integrated CBT with computerized cognitive remediation

Primary outcome

Workforce Participation Measure - Total Number of Jobs Attained
Time frame: Baseline to post-treatment (18-months)
Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end)
Overall Job Attainment Proportion
Time frame: Study start through 18 months of the active portion of the study.
This is the proportion of participants, by group, that attained at least one job during the active portion of the study.
Job Participant Composite-hours Worked
Time frame: Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start.
This is a composite of hours work per week X number of weeks worked, in each assessment period.

2 secondary outcomes

Work Behavior Inventory
Time frame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)
Specific Levels of Functioning (SLOF)
Time frame: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)

Results and safety

Results posted to the registry on 22 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Integrated CBT With Computerized Cognitive Remediation	37	37
Treatment As Usual	30	30

Primary outcome: Workforce Participation Measure - Total Number of Jobs Attained

Time frame: Baseline to post-treatment (18-months). Mean (Standard Deviation). Unit: Number of jobs attained

Measure	iCBT Group n = 37	TAU Group n = 30
Baseline	0 (0)	0 (0)
18 month follow-up (study end)	0.95 (1.2)	0.43 (0.68)

Primary outcome: Overall Job Attainment Proportion

Time frame: Study start through 18 months of the active portion of the study.. Count of participants. Unit: Participants

Measure	iCBT Group n = 37	TAU Group n = 30
No job attainment	16	20
At least one job attained	21	10

iCBT Group vs TAU Group: p <.05, Fisher Exact
iCBT Group vs TAU Group: Odds Ratio (OR): 2.65 (95% CI 0.97 to 7.13), p <.06, Chi-squared

Population analysed: Participants with diagnoses of schizophrenia or schizoaffective disorder seeking employment

Primary outcome: Job Participant Composite-hours Worked

Time frame: Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start.. Mean (Standard Deviation). Unit: Hours worked

Measure	iCBT Group n = 37	TAU Group n = 30
Baseline to intervention start point	96.5 (361.1)	25.3 (83.6)
Intervention start to 6 mos.	109.3 (228.8)	27.0 (118.5)
6-12 mos.	110.8 (221.6)	77.3 (169.3)
12-18 mos.	123.5 (245.8)	133.4 (304.3)

iCBT Group vs TAU Group: Odds Ratio, log: -.90 (95% CI -2.67 to .89), p <0.33, Mixed Models Analysis
iCBT Group vs TAU Group: Odds Ratio, log: .52 (95% CI -1.14 to 2.19), p <.54, Mixed Models Analysis
iCBT Group vs TAU Group: Odds Ratio, log: 0.31 (95% CI -1.32 to 1.73), p <0.71, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
iCBT Group	12 of 37 (32.4%)	0 of 37 (0%)	2 of 37
TAU Group	9 of 30 (30%)	0 of 30 (0%)	0 of 30

Limitations and caveats (from the sponsor): The population for which this study was designed were highly functionally impaired by serious psychiatric illness as an effort to improve employment outcomes in this vulnerable group. This led to significant problems with the ability for participants to respond to and complete requests for ongoing participation in study activities and assessments. The significant missing data was the result of these issues.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven L. Sayers, PhD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Workforce Participation Measure - Total Number of Jobs Attained (time frame: Baseline to post-treatment (18-months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01992913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.