- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02663349
Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55417
- Minneapolis VA Health Care System
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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A manualized group therapy that teaches social cognitive skills.
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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
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This task measures emotion recognition ability.
Total score ranges from 0-21.
A higher score indicates better performance.
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Total score at Baseline and 3 months
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Bell-Lysaker Emotion Recognition Task Total Score
Time Frame: Total score at Baseline and at 6 months
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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
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Facial Emotion Identification Test Total Score
Time Frame: Total score at Baseline and at 3 months
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This is a measure of emotion recognition.
Total score ranges from 0-19.
A higher score indicates better emotion recognition ability.
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Total score at Baseline and at 3 months
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Facial Emotion Identification Test Total Score
Time Frame: Total score at Baseline and at 6 months
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This is a measure of emotion recognition ability.
Scores range from 0-19.
A higher score indicates better performance.
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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
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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
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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
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The Awareness of Social Inference Test Total Score for Part 3
Time Frame: Total score at Baseline and at 3 months
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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.
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Total score at Baseline and at 3 months
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The Awareness of Social Inference Task Total Score on Part 3
Time Frame: Total score at Baseline and at 6 months
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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.
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Total score at Baseline and at 6 months
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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
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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.
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Total score at Baseline and at 3 months
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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.
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Total score at Baseline and at 6 months
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First Episode Social Functioning Scale Performance Total Score on Scales 1-7
Time Frame: Total score at Baseline and at 3 months
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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.
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Total score at Baseline and at 3 months
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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.
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Total Score at Baseline and at 6 months
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Mentoring and Communication Support Scale Subscale Total Scores
Time Frame: Total scores at Baseline and at 3 months
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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.
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Total scores at Baseline and at 3 months
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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.
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Total score at Baseline and at 6 month assessments
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Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Total Scores
Time Frame: Total score at Baseline and at 3 months
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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.
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Total score at Baseline and at 3 months
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Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Subscale Total Scores
Time Frame: Total score at Baseline and at 6 months
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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.
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Total score at Baseline and at 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Completion of the Training Protocol
Time Frame: 3-months
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Percentage of participants who began the intervention and completed the 3-month training protocol
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3-months
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Collaborators and Investigators
Investigators
- Principal Investigator: Tasha M Nienow, PhD, Minneapolis Veterans Affairs Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4612-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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