Clinical trial NCT02663349: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Psychotic Disorders
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: Minnesota Veterans Medical Research and Education Foundation
First posted: 2016-01-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. 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.


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

Primary outcomes:
measure: Bell-Lysaker Emotion Recognition Task Total Score
timeFrame: Total score at Baseline and 3 months
measure: Bell-Lysaker Emotion Recognition Task Total Score
timeFrame: Total score at Baseline and at 6 months
measure: Facial Emotion Identification Test Total Score
timeFrame: Total score at Baseline and at 3 months
measure: Facial Emotion Identification Test Total Score
timeFrame: Total score at Baseline and at 6 months
measure: Ambiguous Intentions and Hostility Scale - Hostility and Aggression Total Scores
timeFrame: Total score at Baseline and at 3 months
measure: Ambiguous Intentions and Hostility Scale -Hostility and Aggression Scale Total Scores
timeFrame: Total score at Baseline and at 6 months
measure: The Awareness of Social Inference Test Total Score for Part 3
timeFrame: Total score at Baseline and at 3 months
measure: The Awareness of Social Inference Task Total Score on Part 3
timeFrame: Total score at Baseline and at 6 months
Secondary outcomes:
measure: Social Skill Performance Assessment Total Score
timeFrame: Total score at Baseline and at 3 months
measure: Social Skill Performance Assessment Total Score
timeFrame: Total score at Baseline and at 6 months
measure: First Episode Social Functioning Scale Performance Total Score on Scales 1-7
timeFrame: Total score at Baseline and at 3 months
measure: First Episode Social Functioning Scale Performance Total Score on Scales 1-7
timeFrame: Total Score at Baseline and at 6 months
measure: Mentoring and Communication Support Scale Subscale Total Scores
timeFrame: Total scores at Baseline and at 3 months
measure: Mentoring and Communication Support Scale Subscale Total Scores
timeFrame: Total score at Baseline and at 6 month assessments
measure: Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Total Scores
timeFrame: Total score at Baseline and at 3 months
measure: Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Subscale Total Scores
timeFrame: Total score at Baseline and at 6 months
Other outcomes:
measure: Percentage of Participants With Completion of the Training Protocol
timeFrame: 3-months
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Tasha M Nienow, PhD
role: PRINCIPAL_INVESTIGATOR
References: