Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness

June 9, 2022 updated by: Tasha Nienow, Minneapolis Veterans Affairs Medical Center

Maintenance of employment is dependent upon being able to successfully integrate into one's work setting. This can present a significant challenge to individuals with serious mental illness, as they typically exhibit impairment in their ability to accurately perceive and understand social exchanges. Presently the most established intervention is Social Cognition and Interaction Training (SCIT), a 12-week group intervention in which participants learn strategies to enhance emotion recognition and to assess the accuracy of their interpretation of social interactions. To enhance transfer of training gains to functional outcomes, participants will be paired with a social mentor to facilitate completion of homework and to ensure that skills are practiced outside of treatment (supported SCIT). The study will examine the impact of supported SCIT on social and work role functioning.

The specific aims are:

  1. To assess the feasibility of providing supported SCIT to individuals with serious mental illness who are engaged in compensated work activity.
  2. To assess the impact of supported SCIT on social cognitive skills as well as work and social performance.
  3. To assess durability of intervention-induced change 3 months after the end of intervention.

A single blind study will be conducted in which participants between 18-70 with serious mental illness (schizophrenia, schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported SCIT. Intervention will consist of one 2-hour small group training sessions and 30 minutes of individualized supported practice of skills with a treatment facilitator weekly. Feasibility will be assessed with attendance at group and individual sessions. Baseline, post-intervention (3-month), and follow-up (6-month) assessments will measure social cognitive abilities and functional outcomes. Potentially confounding variables such as symptom severity and outside treatment hours will also be assessed. It is hypothesized that supported SCIT will be completed by at least 75% of veterans. The intervention is predicted to improve social cognitive skills and social and work performance. Training gains are expected to be sustained 3 months after intervention.

Study Overview

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VA Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
  • Veteran
  • Engaged in compensated work activity, volunteer work, school
  • Age 18 to 70

Exclusion Criteria:

  • Currently meet criteria for substance abuse or have met criteria for substance dependence in that previous 6 months
  • Have an estimated premorbid IQ below 70,
  • Have a history of a clinically significant head injury or neurological disease
  • Do not speak English well enough to comprehend testing procedures
  • Do not demonstrate adequate understanding of study procedures to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Supported SCIT
Social Cognition and Interaction Training is a manualized intervention that focuses on emotion recognition training, perspective taking, and strategies to avoid jumping to conclusions. One 2-hour group session will be offered once a week for 12 weeks. In addition, 30 minutes of individual training will be provided weekly by an instructor.
A manualized group therapy that teaches social cognitive skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bell-Lysaker Emotion Recognition Task Total Score
Time Frame: Total score at Baseline and 3 months
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Total score at Baseline and 3 months
Bell-Lysaker Emotion Recognition Task Total Score
Time Frame: Total score at Baseline and at 6 months
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Total score at Baseline and at 6 months
Facial Emotion Identification Test Total Score
Time Frame: Total score at Baseline and at 3 months
This is a measure of emotion recognition. Total score ranges from 0-19. A higher score indicates better emotion recognition ability.
Total score at Baseline and at 3 months
Facial Emotion Identification Test Total Score
Time Frame: Total score at Baseline and at 6 months
This is a measure of emotion recognition ability. Scores range from 0-19. A higher score indicates better performance.
Total score at Baseline and at 6 months
Ambiguous Intentions and Hostility Scale - Hostility and Aggression Total Scores
Time Frame: Total score at Baseline and at 3 months

The Hostility Total score is a measure of attributional bias and reflects the amount of hostility that is perceived in the actions of others when a situation is ambiguous. Score ranges from 1 (Not at all Hostile, An accident) to 5 (Very Hostile, the other person intended to hurt me) A higher score indicates greater hostility is perceived.

The Aggression Total score is a measure of how aggressively a participant reports that they would respond to an ambiguous situation in which they are mistreated. Score ranges from 1 (Not at all Aggressive, participant says he would do nothing) to 5 (Very Aggressive, participant would retaliate physically). A 1 is a passive response, a 3 is an assertive response, and a 5 is a very aggressive response.

Total score at Baseline and at 3 months
Ambiguous Intentions and Hostility Scale -Hostility and Aggression Scale Total Scores
Time Frame: Total score at Baseline and at 6 months

The Hostility Total score is a measure of attributional bias and reflects the amount of hostility that is perceived in the actions of others when a situation is ambiguous. Score ranges from 1 (Not at all Hostile, An accident) to 5 (Very Hostile, the other person intended to hurt me) A higher score indicates greater hostility is perceived.

The Aggression Total score is a measure of how aggressively a participant reports that they would respond to an ambiguous situation in which they are mistreated. Score ranges from 1 (Not at all Aggressive, participant says he would do nothing) to 5 (Very Aggressive, participant would retaliate physically). A 1 is a passive response, a 3 is an assertive response, and a 5 is a very aggressive response.

Total score at Baseline and at 6 months
The Awareness of Social Inference Test Total Score for Part 3
Time Frame: Total score at Baseline and at 3 months
The Awareness of Social Inference Test (TASIT) total score for Part 3 is a measure of a person's ability to perceive social inferences involved in the telling of lies and the use of sarcasm. The total score ranges from 0 to 64. A higher score indicates better social inference performance.
Total score at Baseline and at 3 months
The Awareness of Social Inference Task Total Score on Part 3
Time Frame: Total score at Baseline and at 6 months
The Awareness of Social Inference Test (TASIT) total score for Part 3 is a measure of a person's ability to perceive social inferences involved in the telling of lies and the use of sarcasm. The total score ranges from 0 to 64. A higher score indicates better social inference performance.
Total score at Baseline and at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Skill Performance Assessment Total Score
Time Frame: Total score at Baseline and at 3 months
The Total score is a measure of social skill demonstrated in two role plays of everyday social situations. Total score can range from 17-85. A higher score indicates more skillful performance.
Total score at Baseline and at 3 months
Social Skill Performance Assessment Total Score
Time Frame: Total score at Baseline and at 6 months
The Total score is a measure of social skill demonstrated in two role plays of everyday social situations. Total score can range from 17-85. A higher score indicates more skillful performance.
Total score at Baseline and at 6 months
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
Time Frame: Total score at Baseline and at 3 months
Self-report measures of social and community functioning in the past 3 month in the following domains: independent living skills, interacting with people, social activities, intimacy, friendships, family relationships and work. Score reflects participant's report of the frequency with which they engaged in behavior. Total score is a sum of items that range from 1 to 4. The Total score range is 28-112, with a higher score indicating better social functioning in the community.
Total score at Baseline and at 3 months
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
Time Frame: Total Score at Baseline and at 6 months
Self-report measures of social and community functioning in the past 3 month in the following domains: independent living skills, interacting with people, social activities, intimacy, friendships, family relationships and work. Score reflects participant's report of the frequency with which they engaged in behavior. Total score is a sum of items that range from 1 to 4. The Total score range is 28-112, with a higher score indicating better social functioning in the community.
Total Score at Baseline and at 6 months
Mentoring and Communication Support Scale Subscale Total Scores
Time Frame: Total scores at Baseline and at 3 months
The Mentoring and Communication Support 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.
Total scores at Baseline and at 3 months
Mentoring and Communication Support Scale Subscale Total Scores
Time Frame: Total score at Baseline and at 6 month assessments
The Mentoring and Communication Support 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.
Total score at Baseline and at 6 month assessments
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Total Scores
Time Frame: Total score at Baseline and at 3 months
The Vocational Efficacy in Trauma Survivors 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.
Total score at Baseline and at 3 months
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Subscale Total Scores
Time Frame: Total score at Baseline and at 6 months
The Vocational Efficacy in Trauma Survivors 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.
Total score at Baseline and at 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Completion of the Training Protocol
Time Frame: 3-months
Percentage of participants who began the intervention and completed the 3-month training protocol
3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tasha M Nienow, PhD, Minneapolis Veterans Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

January 19, 2016

First Submitted That Met QC Criteria

January 21, 2016

First Posted (Estimate)

January 26, 2016

Study Record Updates

Last Update Posted (Actual)

March 23, 2023

Last Update Submitted That Met QC Criteria

June 9, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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