Recruiting

Social-Cognitive Skills

Sponsor:

VA Office of Research and Development

Code:

NCT05491538

Conditions

Schizophrenia

Bipolar Disorder

Depressive Disorder, Major

Stress Disorder, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief 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. 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.

Conditions

Schizophrenia

Bipolar Disorder

Depressive Disorder, Major

Stress Disorder, Post-Traumatic

Study ID

NCT05491538

Start date

Dec 1, 2022

Status verified date

Oct, 2025

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 27, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Social Cognition and Interaction Training-Work Edition

Social 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.

Interventions

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 measure

  • Social Adjustment Scale-Self-Report: Short Version (SAS-SR: Short) Change [ Time Frame: Baseline and 3 months ]
  • Social Adjustment Scale-Self-Report: Short Version (SAS-SR: Short) Change [ Time Frame: Baseline and 6 months ]
  • Recovering Quality of Life (ReQoL)-20 Change [ Time Frame: Baseline and 3 months ]
  • Recovering Quality of Life (ReQoL)-20 Change [ Time Frame: Baseline and 6 months ]
  • Return to Work Self-Efficacy Scale (RTW-SE) Change [ Time Frame: Baseline and 3 months ]
  • Intrinsic Motivation Inventory - Interest subscale [ Time Frame: 3 months ]
  • Intrinsic Motivation Inventory - Interest subscale [ Time Frame: 6 months ]
  • Intrinsic Motivation Inventory - Value subscale [ Time Frame: 3 months ]
  • Intrinsic Motivation Inventory - Value subscale [ Time Frame: 6 months ]
  • Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 3 months ]
  • Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: 6 months ]
  • Rate of Treatment Uptake [ Time Frame: Recruitment ]
  • Completer of Skills Training Intervention [ Time Frame: 3 months ]
  • Retention in supported employment [ Time Frame: 3 months ]
  • Retention in supported employment [ Time Frame: 6 months ]
  • Retention in skills training program [ Time Frame: 3 months ]
  • Retention in skills training program [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Principal Investigator:

Tasha Marie Nienow, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • social cognition
  • employment, supported
  • psychotherapy, group
  • mental health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-09.