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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663349
• Other study ID #: 4612-A
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: July 2019

Study information

• Verified date: June 2022
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Psychotic Disorders
• Schizophrenia

Intervention

Behavioral:
• Social Cognition and Intervention Training
A manualized group therapy that teaches social cognitive skills.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	Minnesota Veterans Medical Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percentage of Participants With Completion of the Training Protocol	Percentage of participants who began the intervention and completed the 3-month training protocol	3-months
Primary	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.	Total score at Baseline and 3 months
Primary	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.	Total score at Baseline and at 6 months
Primary	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.	Total score at Baseline and at 3 months
Primary	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.	Total score at Baseline and at 6 months
Primary	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.	Total score at Baseline and at 3 months
Primary	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.	Total score at Baseline and at 6 months
Primary	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.	Total score at Baseline and at 3 months
Primary	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.	Total score at Baseline and at 6 months
Secondary	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.	Total score at Baseline and at 3 months
Secondary	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.	Total score at Baseline and at 6 months
Secondary	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.	Total score at Baseline and at 3 months
Secondary	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.	Total Score at Baseline and at 6 months
Secondary	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.	Total scores at Baseline and at 3 months
Secondary	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.	Total score at Baseline and at 6 month assessments
Secondary	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.	Total score at Baseline and at 3 months
Secondary	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.	Total score at Baseline and at 6 months