ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02663349
Recruitment Status : Enrolling by invitation
First Posted : January 26, 2016
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
Minnesota Veterans Medical Research and Education Foundation
Information provided by (Responsible Party):
Tasha Nienow, Minneapolis Veterans Affairs Medical Center

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 randomized, active-placebo controlled, parallel groups, single blind study will be conducted in which 60 participants between 18-60 with serious mental illness (schizophrenia, schizoaffective disorder, and bipolar disorder) are assigned to 12 weeks of supported SCIT or an active placebo condition, a computer skills course. Each intervention will consist of two 1-hour small group training sessions and 1 hour 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, and follow-up 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 assigned to that condition. 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.


Condition or disease Intervention/treatment Phase
Schizophrenia Bipolar Disorder Psychotic Disorders Behavioral: Social Cognition and Intervention Training Behavioral: Computer Skills Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
Study Start Date : January 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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 hour group sessions will be offered twice a week for 12 weeks. In addition, one hour of individual training will be provided weekly by an instructor.
Behavioral: Social Cognition and Intervention Training
A manualized group therapy that teaches social cognitive skills.

Active Comparator: Computer Skills
This computer application class is manualized class that teaches word processing skills with Microsoft Word and PowerPoint software. Two 1 hour group sessions will be offered weekly. In addition, participants will be scheduled to practice skills for one hour weekly with the support of an instructor.
Behavioral: Computer Skills
Computer Application course




Primary Outcome Measures :
  1. Bell-Lysaker Emotion Recognition Task total score [ Time Frame: Change from Baseline total score at 3 months ]
    The Awareness of Social Inference Task

  2. Bell-Lysaker Emotion Recognition Task total score [ Time Frame: Change from Baseline total score at 6 months ]
  3. Facial Emotion Identification Test total score [ Time Frame: Change from Baseline total score at 3 months ]
  4. Facial Emotion Identification Test total score [ Time Frame: Change from Baseline total score at 6 months ]
  5. Ambiguous Intentions and Hostility Scale total [ Time Frame: Change from Baseline total score at 3 months ]
  6. Ambiguous Intentions and Hostility Scale total score [ Time Frame: Change from Baseline total score at 6 months ]
  7. The Awareness of Social Inference Task total score [ Time Frame: Change from Baseline total score at 3 months ]
  8. The Awareness of Social Inference Task total score [ Time Frame: Change from Baseline total score at 6 months ]

Secondary Outcome Measures :
  1. Social Skill Performance Assessment total score [ Time Frame: Change from Baseline total score at 3 months ]
  2. Social Skill Performance Assessment total score [ Time Frame: Change from Baseline total score at 6 months ]
  3. First Episode Social Functioning Scale total score [ Time Frame: Change from Baseline total score at 3 months ]
  4. First Episode Social Functioning Scale total score [ Time Frame: Change from Baseline total score at 6 months ]
  5. Asocial Beliefs Scale total score [ Time Frame: Change from Baseline total score at 3 months ]
  6. Asocial Beliefs Scale total score [ Time Frame: Change from Baseline total score at 6 months ]
  7. World Health Organization Work Performance Questionnaire total score [ Time Frame: Change from Baseline total score at 3 months ]
  8. World Health Organization Work Performance Questionnaire total score [ Time Frame: Change from Baseline total score at 6 months ]
  9. Mentoring and Communication Support Scale total score [ Time Frame: Change from Baseline total score at 3 months ]
  10. Mentoring and Communication Support Scale total score [ Time Frame: Change from Baseline total score at 6 months ]
  11. Working Alliance Inventory total score [ Time Frame: Change from Baseline total score at 3 months ]
  12. Working Alliance Inventory total score [ Time Frame: Change from Baseline total score at 6 months ]
  13. Work Stress Questionnaire total score [ Time Frame: Change from Baseline total score at 3 months ]
  14. Work Stress Questionnaire total score [ Time Frame: Change from Baseline total score at 6 months ]

Other Outcome Measures:
  1. Completion Rates [ Time Frame: Percentage of participants who remain in the protocl at 3 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663349


Locations
United States, Minnesota
Minneapolis VA Health Care System
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Minnesota Veterans Medical Research and Education Foundation
Investigators
Principal Investigator: Tasha M Nienow, PhD Minneapolis VA Health Care System

Responsible Party: Tasha Nienow, Principal Investigator, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02663349     History of Changes
Other Study ID Numbers: 4612-A
First Posted: January 26, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders