NCT05491538 · VA Office of Research and Development
Acceptability and Feasibility of Work-Oriented Social-Cognitive Skills Training for Veterans With Serious Mental Illness
What this study is about
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.
View original scientific description
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. 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.
Interventions
BEHAVIORAL
Social Cognition and Interaction Training-Work Edition (SCIT-WE)
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.
Primary outcome measures
Social Adjustment Scale-Self-Report: Short Version (SAS-SR: Short) Change
Time frame: Baseline and 3 months
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.
Social Adjustment Scale-Self-Report: Short Version (SAS-SR: Short) Change
Time frame: Baseline and 6 months
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.
Recovering Quality of Life (ReQoL)-20 Change
Time frame: Baseline and 3 months
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.
Recovering Quality of Life (ReQoL)-20 Change
Time frame: Baseline and 6 months
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.
Return to Work Self-Efficacy Scale (RTW-SE) Change
Time frame: Baseline and 3 months
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.
Intrinsic Motivation Inventory - Interest subscale
Time frame: 3 months
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.
Intrinsic Motivation Inventory - Interest subscale
Time frame: 6 months
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.
Intrinsic Motivation Inventory - Value subscale
Time frame: 3 months
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.
Intrinsic Motivation Inventory - Value subscale
Time frame: 6 months
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.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 3 months
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.
Client Satisfaction Questionnaire (CSQ-8)
Time frame: 6 months
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.
Rate of Treatment Uptake
Time frame: Recruitment
Percentage of eligible participants who express interest in the intervention
Completer of Skills Training Intervention
Time frame: 3 months
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.
Retention in supported employment
Time frame: 3 months
Percentage of study participants who remain involved in supported employment 3 months post-enrollment.
Retention in supported employment
Time frame: 6 months
Percentage of study participants who remain involved in supported employment 6 months post-enrollment.
Retention in skills training program
Time frame: 3 months
Percentage of study participants who remain enrolled in the study 3 months post-enrollment.
Retention in skills training program
Time frame: 6 months
Percentage of study participants who remain enrolled in the study 6 months post-enrollment.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 PTSD.
Exclusion criteria
- 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
- 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
Where
- Minneapolis, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2025 · Source of record for eligibility and locations