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

NCT02663349 | Completed Results

• 1 other identifier: 4612-A
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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:

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

Conditions

Schizophrenia; Bipolar Disorder; Psychotic Disorders

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (8)

• Social Skill Performance Assessment Total Score

  Total score at Baseline and at 3 months

• Social Skill Performance Assessment Total Score

  Total score at Baseline and at 6 months

• First Episode Social Functioning Scale Performance Total Score on Scales 1-7

  Total score at Baseline and at 3 months

• First Episode Social Functioning Scale Performance Total Score on Scales 1-7

  Total Score at Baseline and at 6 months

• Mentoring and Communication Support Scale Subscale Total Scores

  Total scores at Baseline and at 3 months

Other Outcomes (1)

• Percentage of Participants With Completion of the Training Protocol

  3-months

Study Arms (1)

Supported SCIT

EXPERIMENTAL

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.

Behavioral: Social Cognition and Intervention Training

Interventions

Social Cognition and Intervention Training BEHAVIORAL

A manualized group therapy that teaches social cognitive skills.

Supported SCIT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead
• Minnesota Veterans Medical Research and Education Foundation: collaborator

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Schizophrenia; Bipolar Disorder; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders

Results Point of Contact

• Title: Tasha Nienow, PhD
• Organization: Minneapolis VA Health Care System

tasha.nienow@va.gov

612-467-1004

Study Officials

• Tasha M Nienow, PhD

  Minneapolis Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: July 1, 2019
• Last Updated: March 23, 2023
• Results First Posted: March 23, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)