NCT05491538

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
19mo left

Started Dec 2022

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Dec 2022Nov 2027

First Submitted

Initial submission to the registry

August 3, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

4 years

First QC Date

August 3, 2022

Last Update Submit

October 8, 2025

Conditions

Keywords

social cognitionemployment, supportedpsychotherapy, groupmental health

Outcome Measures

Primary Outcomes (17)

  • 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.

    Baseline and 3 months

  • 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.

    Baseline and 6 months

  • 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.

    Baseline and 3 months

  • 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.

    Baseline and 6 months

  • 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.

    Baseline and 3 months

  • 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.

    3 months

  • 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.

    6 months

  • 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.

    3 months

  • 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.

    6 months

  • 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.

    3 months

  • 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.

    6 months

  • Rate of Treatment Uptake

    Percentage of eligible participants who express interest in the intervention

    Recruitment

  • 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.

    3 months

  • Retention in supported employment

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

    3 months

  • Retention in supported employment

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

    6 months

  • Retention in skills training program

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

    3 months

  • Retention in skills training program

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

    6 months

Secondary Outcomes (3)

  • Mentoring and Communication Support Scale (MCSS)

    6 months

  • Vocational Efficacy in Trauma Survivors Scale

    6 months

  • Work Limitations Questionnaire (WLQ)

    6 months

Study Arms (1)

Social Cognition and Interaction Training-Work Edition

EXPERIMENTAL

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.

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

Interventions

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.

Social Cognition and Interaction Training-Work Edition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

MeSH Terms

Conditions

SchizophreniaBipolar DisorderDepressive Disorder, MajorStress Disorders, Post-TraumaticPsychological Well-Being

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersDepressive DisorderStress Disorders, TraumaticTrauma and Stressor Related DisordersPersonal SatisfactionBehavior

Study Officials

  • Tasha Marie Nienow, PhD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tasha M Nienow, PhD

CONTACT

Laura A Meis, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2022

First Posted

August 8, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

November 27, 2026

Study Completion (Estimated)

November 30, 2027

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Final datasets will be available at study completion in November 2024. They will remain available for at least 6 years post study closure.
Access Criteria
De-identified data will be made available so that analyses can be re-run, secondary analyses can be completed, and study data can be included in future meta-analyses. When the principal investigator receives a request from another investigator, the dataset and the request will be reviewed by the principal investigator and Minneapolis VA Privacy Officer prior to release.

Locations