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SchizophreniaNCT05491538

Acceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness

A study testing Social Cognition and Interaction Training-Work Edition (SCIT-WE) in people with Schizophrenia and Bipolar Disorder, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Social Cognition and Interaction Training-Work Edition (SCIT-WE)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Dec 2022to 30 Nov 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veterans who are outpatients and enrolled to receive supported services at the Minneapolis VA Health Care System
  • Veterans are eligible for this program if they are receiving services from a mental health team at the Minneapolis VA Health Care System, are motivated to pursue employment, and are seeking employment within 30 miles of the medical center
  • Veterans will be eligible for the study if they have a DSM-5 diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar I Disorder, Bipolar II Disorder, Recurrent Major Depressive Disorder, or post-traumatic stress disorder (PTSD)

Who cannot join

  • Study exclusion criteria are:
  • presence of a moderate or severe traumatic brain injury
  • presence of a cognitively compromising neurological disease
  • understanding of English that is not sufficient for comprehension of testing procedures
  • premorbid IQ less than 70
  • behavior that prevents participation in a group intervention
Show all 13Show fewer
  • hearing or visual impairment that prevents completion of intervention and testing procedures
  • clinical instability, defined as active suicidal ideation or hospitalization in the previous 4 weeks
  • current diagnosis of alcohol or substance use disorder, severe
  • current participation in another mental health intervention study
  • inability to commit to 7-9 months of study participation due to a planned move or unstable housing
  • inability to provide informed consent
  • presence of a guardian of person

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tasha M Nienow, PhD contact

(612) 467-1004

Tasha.Nienow@va.gov

Laura A Meis, PhD contact

(612) 467-4516

laura.meis@va.gov

United States1 site, 1 recruiting
  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417-2309

    Tasha M Nienow, PhD, (612) 467-1004, Tasha.Nienow@va.gov

    Laura A Meis, PhD, (612) 467-4516, laura.meis@va.gov

    Recruiting

Other trials in United States

About this study

Official title: Acceptability and Feasibility of Work-Oriented, Veteran-Centric, Social-Cognitive Skills Training

Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. The goals of this study are to: 1) adapt an evidence-based social cognitive skills intervention for work settings and use with Veterans, 2) examine the acceptability of the work focused skills training intervention, 3) assess the feasibility of combining the social cognitive skills training program with supported employment, and 4) examine change on functional outcomes.

The current study will use feedback from veteran and employment specialist stakeholders to adapt an evidence-based social cognitive skills training program, Social Cognition and Interaction Training (SCIT). The intervention will be modified to tailor it to work relationships and to address any unique relationship concerns among Veterans that are identified by stakeholders. SCIT-Work Edition (SCIT-WE) will add: 1) education about work-related social norms; 2) examples of work-related social interactions that require perspective taking and problem- solving; 3) individual sessions with the study therapist to enhance learning and relevance to each participant's goals; 4) structured interactions with the participant's employment specialist to practice skills outside of group; and 5) skill application sessions with the participant's employment specialist that prompt use of skills after training is completed.

Read more

SCIT-WE will be developed and piloted in an open trial with 20 Veterans enrolled in the supported employment program at the Minneapolis VA who have a qualifying serious mental illness diagnosis. SCIT-WE will be offered for 2 hours weekly over 13 weeks, when most participants are in the job development and job search phases of supported employment. While participating in the group skills training, participants will have weekly, individual homework review sessions with the group facilitator to promote understanding of the skills and to discuss relevance of the skills to personal goals. Participants also will practice skills weekly with their employment specialist for 10-15 minutes to promote use of skills outside of group sessions. In the 3-months following skills training completion, participants will complete 10 15-minute skills review sessions with their employment specialist to encourage continued skill application in a work setting.

Participants will complete assessments at baseline, before receiving the intervention; 3-months post-enrollment, after participating in a weekly skills training group; and 6-months post-enrollment, after receiving 10 additional individual skills review sessions with their employment specialist. Accessibility will be measured with rate of treatment uptake, rate of treatment completion, and participant attitudes toward the intervention. Feasibility of the intervention will be assessed by examining retention in supported employment and the study at 3- and 6-months post-enrollment. Impact of the intervention will be examined with measures of quality of life, social adjustment, self-efficacy, and work relationship quality. It is hypothesized that the intervention will be acceptable to Veterans. The investigators predict a 50% treatment uptake rate, a 70% intervention completion rate, and positive ratings on measures of satisfaction, interest, and value. The investigators hypothesize that it will be feasible to complete this intervention in combination with supported employment activities. The investigators predict that retention in both skills training and supported employment will be 75% at 3-months post-enrollment and 60% 6-months post enrollment. The investigators hypothesize that positive change will be seen at 3-months post-enrollment and sustained at 6-months post-enrollment on measures of quality of life and social adjustment. The investigators predicted that self-efficacy regarding return to work will be improved at 3-months post-enrollment. The investigators predict that Veterans will report being productive and having positive work relationships 6-months post-enrollment.

The findings will inform the development of a novel intervention targeting the social and functional impairments associated with serious mental illness. The knowledge gained from this study will guide the development of the next generation of interventions. Given that employment is a critical part of recovery, advancement in therapeutic interventions that support Veterans in this process will be of significance.

Read the detailed description

Rationale and Study Aims: Many individuals with serious mental illness have difficulty accurately interpreting interpersonal cues and effectively engaging in social exchanges. Difficulties related to the interpersonal aspects of work can lead to isolation, poor productivity, and job loss. As a contributor to role functioning, social cognitive ability has become an intervention target. The most established intervention, Social Cognition and Interaction Training (SCIT), is a group psychotherapy that targets 3 social cognitive domains: emotion recognition, theory of mind, and attributional bias. SCIT offers 20-24 hours of instruction and has been delivered to individuals with schizophrenia, bipolar disorder, and depression previously. The goals of this study are to: 1) adapt SCIT for work settings and use with Veterans, 2) examine the acceptability of the work focused skills training intervention, 3) assess the feasibility of combining the social cognitive skills training program with supported employment, and 4) examine change on functional outcomes.

Intervention Development: The SCIT curriculum has three phases. Phase 1 focuses on the role of emotions in social situations and recognizing emotion in self and others. Phase 2 focuses on increasing awareness of cognitive biases and teaching strategies to avoid jumping to conclusions. Phase 3 focuses on integrating skills and applying them to social situations through a social problem-solving process. Social Cognition and Interaction Training-Work Edition (SCIT-WE) will follow the same three phase structure as SCIT. Based upon feedback from stakeholders, this curriculum will be expanded. To contextualize the intervention for work settings and for use with a Veteran population, semi-structured stakeholder interviews will be conducted with Veterans who have participated in supported employment in the previous five years (n = 20) and employment specialists at the Minneapolis VAHCS (n = 5). Stakeholders will be asked about work experiences, work-related social problems that are commonly encountered/observed, types of training/feedback currently received through the supported employment program, feedback about additions to the curriculum, and concerns about the proposed integration of SCIT-WE with supported employment. Notes will be taken during the interviews and used to identify educational topics and types of skills training that would be most useful additions to the curriculum.

Four to six hours of content will be added to the SCIT group session curriculum focused on workplace social norms, expression and regulation of emotion at work, and communication styles. In addition, training materials will be developed to supplement the SCIT curriculum: (1) standardized homework assignments that reinforce the SCIT curriculum with work-related scenarios; (2) standardized activities that participants can complete with their employment specialist to practice skills outside of sessions; (3) standardized skill application session materials to prompt continued use of skills after training sessions are completed; and (4) materials to standardize communications between the study therapist and the employment specialists.

An open trial pilot study will be conducted with 20 Veterans who are outpatients and enrolled to receive supported employment services at the Minneapolis VA Health Care System. Veterans participating in supported employment are receiving services from a mental health team, are motivated to pursue employment, and are seeking employment within 30 miles of the medical center. Veterans will be provided with information about the study after enrollment in supported employment. Veterans who express an interest in the study will complete a screening interview that establishes psychiatric diagnosis and eligibility for the study.

Veterans who choose to enroll in the study will attend one 2-hour SCIT-WE session weekly for 13 weeks, when most participants are in the job development and job search phases of supported employment. Group size will be 4 or fewer Veterans. The group will be facilitated by a doctoral level therapist who has received training from one of the intervention developers and who has over five years of experience offering SCIT to Veterans. To promote generalization of skills training, weekly homework and practice partner assignments will be given to participants to complete outside of group. The group facilitator will contact participants by phone each week for a 15-30-minute individual review of assigned homework and to discuss its relevance to their personal goals. Veterans will complete the practice partner assignments during sessions with their employment specialist. Practice partner activities will take 10-15 minutes to complete in session. These activities are an opportunity for the Veteran to practice using a skill introduced during group with someone outside of group. While a Veteran is participating in SCIT-WE, the group facilitator will contact the employment specialist at the end of each training phase to provide feedback about the Veteran's social cognitive performance. Upon completion of SCIT-WE skills training group, Veterans will continue to meet with their employment specialist for supported employment activities. In the 3 months post-skills training, employment specialists will use structured intervention materials developed for SCIT-WE during 10 sessions to prompt skill application. This material will add 15 minutes to their sessions with participants.

Assessments: To evaluate the intervention, participants will complete assessments at baseline, before receiving the intervention; 3-months post-enrollment, after participating in a weekly skills training group; and 6-months post-enrollment, after receiving 10 additional individual skills review sessions with their employment specialist. Accessibility will be measured with rate of treatment uptake, rate of treatment completion, and participant attitudes toward the intervention. Feasibility of the intervention will be assessed by examining retention in supported employment and the study at 3- and 6-months post-enrollment. Impact of the intervention will be examined with measures of quality of life, social adjustment, self-efficacy, and work relationship quality. It is hypothesized that the intervention will be acceptable to Veterans. The investigators predict a 50% treatment uptake rate, a 70% intervention completion rate, and positive ratings on measures of satisfaction, interest, and value. The investigators hypothesize that it will be feasible to complete this intervention in combination with supported employment activities. The investigators predict that retention in both skills training and supported employment will be 75% at 3-months post-enrollment and 60% 6-months post enrollment. The investigators hypothesize that positive change will be seen at 3-months post-enrollment and sustained at 6-months post-enrollment on measures of quality of life and social adjustment. The investigators predicted that self-efficacy regarding return to work will be improved at 3-months post-enrollment. Direction and magnitude of change will be measured with Cohen's d and 95% confidence intervals. The investigators predict that veterans will report being productive and having positive work relationships 6-months post-enrollment.

Treatment Manual Development: To gain additional insights about the experience of the intervention for participants, an exit interview will be completed 6-months post-enrollment. Veterans who enroll in the open trial pilot (n = 20) and employment specialists (n = 5) who use the educational materials developed for this project will each complete a 90-minute, semi-structured exit interview. The interview will assess: (1) attitudes about the intervention components, structure, and materials; (2) suggestions for intervention improvement; (3) impact of the training on intervention targets and unexpected impacts; and (4) barriers and facilitators to training participation. Interviews will be conducted by phone or in-person by a doctoral level clinician. Exit interviews will be transcribed and processed using an efficient, rapid turn-around analytic approach to identify key themes. Based upon participant feedback, a SCIT-WE treatment manual will be finalized for use in future research.

Significance: The findings will inform the development of a novel intervention targeting the social and functional impairments associated with serious mental illness. The knowledge gained from this study will guide the development of the next generation of interventions. Given that employment is a critical part of recovery, advancement in therapeutic interventions that support Veterans in this process will be of significance.

Being tested
Social Cognition and Interaction Training-Work Edition (SCIT-WE)
Keywords
social cognition, employment, supported, psychotherapy, group, mental health
Medical subject headings
Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

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

  • Social Cognition and Interaction Training-Work Edition (SCIT-WE)Behavioural

    Participants will attend 1 2-hour skills training group weekly for 13 weeks after enrolling in supported employment. In addition to the group session, participants have a 15-30 minute individual session with the group facilitator weekly to review homework and complete a 10-15 minute exercise with their employment specialist each week to practice skills outside of group. The 13-week skills group is followed by 10 skills review/application sessions conducted during 10 supported employment sessions in the next 13 weeks.

Study groups in NCT05491538
Study groupRoleWhat they receive
Social Cognition and Interaction Training-Work EditionExperimentalSocial Cognition and Interaction Training-Work Edition is a group-based, skills training group that will be offered to participants after they enroll in supported employment.
Receives: Behavioral: Social Cognition and Interaction Training-Work Edition (SCIT-WE)

What is being measured

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

  1. Social Adjustment Scale-Self-Report: Short Version (SAS-SR: Short) Change

    This task is a 24-item self-report scale that assesses functioning in 6 social roles in the prior 2 weeks. Total score is a T-score and ranges from 0-100. A higher score indicates more impairment in social role functioning.

    Measured: Baseline and 3 months

  2. Social Adjustment Scale-Self-Report: Short Version (SAS-SR: Short) Change

    This task is a 24-item self-report scale that assesses functioning in 6 social roles in the prior 2 weeks. Total score is a T-score and ranges from 0-100. A higher score indicates more impairment in social role functioning.

    Measured: Baseline and 6 months

  3. Recovering Quality of Life (ReQoL)-20 Change

    This task is a 20-item self-report, recovery-focused quality of life measure. Total score ranges from 0-80. A higher score indicates greater quality of life.

    Measured: Baseline and 3 months

  4. Recovering Quality of Life (ReQoL)-20 Change

    This task is a 20-item self-report, recovery-focused quality of life measure. Total score ranges from 0-80. A higher score indicates greater quality of life.

    Measured: Baseline and 6 months

  5. Return to Work Self-Efficacy Scale (RTW-SE) Change

    This 11-item self-report scale measures self perception of ability to return to work the next day. Total score ranges from 11 to 66. A higher score indicates greater self-confidence in ability to work.

    Measured: Baseline and 3 months

  6. Intrinsic Motivation Inventory - Interest subscale

    This subscale measures self-report of interest and enjoyment from an activity on a 7-point scale. Total score ranges from 1-7, with a higher score indicating greater interest in the training activity. The 3-month measurement will reflect interest and enjoyment in the skills training group.

    Measured: 3 months

  7. Intrinsic Motivation Inventory - Interest subscale

    This subscale measures self-report of interest and enjoyment from an activity on a 7-point scale. Total score ranges from 1-7, with a higher score indicating greater interest in the training activity. The 6-month measurement will reflect interest and enjoyment in the individual skills review sessions.

    Measured: 6 months

  8. Intrinsic Motivation Inventory - Value subscale

    This subscale measures self-report of perceive value and importance of an activity on a 7-point scale. Total score ranges from 1-7, with a higher score indicating greater value in the training activity. The 3-month measurement will reflect value and importance of the skills training group.

    Measured: 3 months

  9. Intrinsic Motivation Inventory - Value subscale

    This subscale measures self-report of perceive value and importance of an activity on a 7-point scale. Total score ranges from 1-7, with a higher score indicating greater value in the training activity. The 6-month measurement will reflect value and importance of the individual skills review sessions.

    Measured: 6 months

  10. Client Satisfaction Questionnaire (CSQ-8)

    This questionnaire is an 8-item self-report measure of satisfaction with health services. Total score ranges from 8-32. A higher score indicates greater satisfaction with services. The 3-month measurement will reflect satisfaction with the skills training group.

    Measured: 3 months

  11. Client Satisfaction Questionnaire (CSQ-8)

    This questionnaire is an 8-item self-report measure of satisfaction with health services. Total score ranges from 8-32. A higher score indicates greater satisfaction with services. The 6-month measurement will reflect satisfaction with the individual skills review sessions.

    Measured: 6 months

  12. Rate of Treatment Uptake

    Percentage of eligible participants who express interest in the intervention

    Measured: Recruitment

  13. Completer of Skills Training Intervention

    Percentage of sample that qualifies as completing the intervention. A participant is defined as a completer is they attend 80% or more of intervention sessions.

    Measured: 3 months

  14. Retention in supported employment

    Percentage of study participants who remain involved in supported employment 3 months post-enrollment.

    Measured: 3 months

  15. Retention in supported employment

    Percentage of study participants who remain involved in supported employment 6 months post-enrollment.

    Measured: 6 months

  16. Retention in skills training program

    Percentage of study participants who remain enrolled in the study 3 months post-enrollment.

    Measured: 3 months

  17. Retention in skills training program

    Percentage of study participants who remain enrolled in the study 6 months post-enrollment.

    Measured: 6 months

Secondary outcomes (3)
  1. Mentoring and Communication Support Scale (MCSS)

    This scale is a self-report measure of perceived relationship quality with colleagues and supervisors at work. The scale has four subscales: Collegial Support, Task Support, Career Mentoring, and Coaching. Collegial Support and Task Support scales indicate the amount of support perceived from co-workers, emotionally and in terms of conveying knowledge about how to do the job. The scales range from 4-20 with a higher score indicating a greater level of perceived support. Career Mentoring and Coaching scales measure support perceived from supervisor in terms of advice as well as instruction on how to do one's job. The Career Mentoring scale ranges from 4-20, with a higher score indicating more support. The Coaching scale ranges from 3-15, with a higher score indicating more support.

    Measured: 6 months

  2. Vocational Efficacy in Trauma Survivors Scale

    This scale is a self-report measure of perceived social support and efficacy coping with mental health symptoms at work. The scale has two subscales: Self Disclosure and Workplace Coping. The Self Disclosure subscale ranges from 4-20, with a higher score indicating greater comfort self disclosing about mental health issues at work. The Workplace Coping subscale ranges from 7-35, with a higher score indicating greater confidence in one's abilities to manage mental health symptoms at work.

    Measured: 6 months

  3. Work Limitations Questionnaire (WLQ)

    This measure is a self-report scale that provides work performance information in four domains: Mental-Interpersonal, Time Management, Output, and Physical Demands. The At-Work Productivity Loss Summary score reflects the percentage of time that the individual had job performance deficits due to mental or physical health problems in the prior 2 weeks. A higher score indicates poorer performance.

    Measured: 6 months

Timeline

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

  1. First posted8 Aug 2022
  2. Study start1 Dec 2022
  3. Primary completion26 Nov 2027 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
This is a single-group, open pilot trial in which participants will receive a group-based social-cognitive skills training program in addition to supported employment services.
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05491538
Sponsor's protocol ID
D4068-P
Other IDs
1I21RX004068-01A1
Status last verified
Sep 2026
First submitted
3 Aug 2022
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is plan to make individual participant data sets available to others. Final, de-identified final datasets that underlie publications will be made available upon written request.

Questions about this trial

What is this clinical trial studying?

A study testing Social Cognition and Interaction Training-Work Edition (SCIT-WE) in people with Schizophrenia and Bipolar Disorder, run by VA Office of Research and Development at 1 site in United States.

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 3 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Tasha M Nienow, PhD ((612) 467-1004, Tasha.Nienow@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Social Adjustment Scale-Self-Report: Short Version (SAS-SR: Short) Change (time frame: Baseline and 3 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 2 Oct 2026.

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