Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
Primary Purpose
Schizophrenia, Bipolar Disorder, Psychotic Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Social Cognition and Intervention Training
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Minneapolis VA Health Care System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Supported SCIT
Arm Description
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.
Outcomes
Primary Outcome Measures
Bell-Lysaker Emotion Recognition Task Total Score
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Bell-Lysaker Emotion Recognition Task Total Score
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Facial Emotion Identification Test Total Score
This is a measure of emotion recognition. Total score ranges from 0-19. A higher score indicates better emotion recognition ability.
Facial Emotion Identification Test Total Score
This is a measure of emotion recognition ability. Scores range from 0-19. A higher score indicates better performance.
Ambiguous Intentions and Hostility Scale - Hostility and Aggression Total Scores
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.
Ambiguous Intentions and Hostility Scale -Hostility and Aggression Scale Total Scores
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.
The Awareness of Social Inference Test Total Score for Part 3
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.
The Awareness of Social Inference Task Total Score on Part 3
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.
Secondary Outcome Measures
Social Skill Performance Assessment Total Score
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.
Social Skill Performance Assessment Total Score
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.
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
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.
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
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.
Mentoring and Communication Support Scale Subscale Total Scores
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.
Mentoring and Communication Support Scale Subscale Total Scores
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.
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Total Scores
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.
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Subscale Total Scores
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.
Full Information
NCT ID
NCT02663349
First Posted
January 19, 2016
Last Updated
June 9, 2022
Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Veterans Medical Research and Education Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02663349
Brief Title
Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
Official Title
Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
July 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minneapolis Veterans Affairs Medical Center
Collaborators
Minnesota Veterans Medical Research and Education Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
To assess the feasibility of providing supported SCIT to individuals with serious mental illness who are engaged in compensated work activity.
To assess the impact of supported SCIT on social cognitive skills as well as work and social performance.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Psychotic Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Supported SCIT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Social Cognition and Intervention Training
Intervention Description
A manualized group therapy that teaches social cognitive skills.
Primary Outcome Measure Information:
Title
Bell-Lysaker Emotion Recognition Task Total Score
Description
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Time Frame
Total score at Baseline and 3 months
Title
Bell-Lysaker Emotion Recognition Task Total Score
Description
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Time Frame
Total score at Baseline and at 6 months
Title
Facial Emotion Identification Test Total Score
Description
This is a measure of emotion recognition. Total score ranges from 0-19. A higher score indicates better emotion recognition ability.
Time Frame
Total score at Baseline and at 3 months
Title
Facial Emotion Identification Test Total Score
Description
This is a measure of emotion recognition ability. Scores range from 0-19. A higher score indicates better performance.
Time Frame
Total score at Baseline and at 6 months
Title
Ambiguous Intentions and Hostility Scale - Hostility and Aggression Total Scores
Description
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.
Time Frame
Total score at Baseline and at 3 months
Title
Ambiguous Intentions and Hostility Scale -Hostility and Aggression Scale Total Scores
Description
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.
Time Frame
Total score at Baseline and at 6 months
Title
The Awareness of Social Inference Test Total Score for Part 3
Description
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.
Time Frame
Total score at Baseline and at 3 months
Title
The Awareness of Social Inference Task Total Score on Part 3
Description
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.
Time Frame
Total score at Baseline and at 6 months
Secondary Outcome Measure Information:
Title
Social Skill Performance Assessment Total Score
Description
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.
Time Frame
Total score at Baseline and at 3 months
Title
Social Skill Performance Assessment Total Score
Description
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.
Time Frame
Total score at Baseline and at 6 months
Title
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
Description
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.
Time Frame
Total score at Baseline and at 3 months
Title
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
Description
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.
Time Frame
Total Score at Baseline and at 6 months
Title
Mentoring and Communication Support Scale Subscale Total Scores
Description
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.
Time Frame
Total scores at Baseline and at 3 months
Title
Mentoring and Communication Support Scale Subscale Total Scores
Description
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.
Time Frame
Total score at Baseline and at 6 month assessments
Title
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Total Scores
Description
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.
Time Frame
Total score at Baseline and at 3 months
Title
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Subscale Total Scores
Description
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.
Time Frame
Total score at Baseline and at 6 months
Other Pre-specified Outcome Measures:
Title
Percentage of Participants With Completion of the Training Protocol
Description
Percentage of participants who began the intervention and completed the 3-month training protocol
Time Frame
3-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tasha M Nienow, PhD
Organizational Affiliation
Minneapolis Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Minneapolis VA Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
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