SchizophreniaNCT02663349
Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
A study testing Social Cognition and Intervention Training in people with Schizophrenia and Bipolar Disorder, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
- What is being tested?
- Social Cognition and Intervention Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
- Veteran
- Engaged in compensated work activity, volunteer work, school
- Age 18 to 70
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis VA Health Care System
Minneapolis, Minnesota, 55417
About this study
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:
Read more
- 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.
- Conditions
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
- Being tested
- Social Cognition and Intervention Training
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition and Intervention TrainingBehavioural
A manualized group therapy that teaches social cognitive skills.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Social Cognition and Intervention Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Total score at Baseline and at 6 months
Secondary outcomes (8)
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.
Measured: Total score at Baseline and at 3 months
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.
Measured: Total score at Baseline and at 6 months
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.
Measured: Total score at Baseline and at 3 months
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.
Measured: Total Score at Baseline and at 6 months
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.
Measured: Total scores at Baseline and at 3 months
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.
Measured: Total score at Baseline and at 6 month assessments
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.
Measured: Total score at Baseline and at 3 months
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.
Measured: Total score at Baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionOct 2018
- Study completionJul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- Minnesota Veterans Medical Research and Education Foundation
- Responsible party
- Principal investigator, Tasha Nienow, Minneapolis Veterans Affairs Medical Center
- Investigators
- Tasha M Nienow, PhD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02663349
- Sponsor's protocol ID
- 4612-A
- Status last verified
- Jun 2022
- First submitted
- 19 Jan 2016
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skills Training to Enhance Vocational Outcomes in Veterans With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT02663349
- Acronym / sponsor ID
- 4612-A
- Conditions
- Schizophrenia, Bipolar Disorder, Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- Minnesota Veterans Medical Research and Education Foundation
- Study start
- Jan 2016 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 26 Jan 2016 (estimated)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supported SCIT | Experimental | Behavioral: Social Cognition and Intervention TrainingSocial 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder
- Veteran
- Engaged in compensated work activity, volunteer work, school
- Age 18 to 70
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Cognition and Intervention TrainingA manualized group therapy that teaches social cognitive skills. | Behavioural | Supported SCIT |
Primary outcome
Bell-Lysaker Emotion Recognition Task Total Score
Time frame: Total score at Baseline and 3 months
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Bell-Lysaker Emotion Recognition Task Total Score
Time frame: Total score at Baseline and at 6 months
This task measures emotion recognition ability. Total score ranges from 0-21. A higher score indicates better performance.
Facial Emotion Identification Test Total Score
Time frame: Total score at Baseline and at 3 months
This is a measure of emotion recognition. Total score ranges from 0-19. A higher score indicates better emotion recognition ability.
Facial Emotion Identification Test Total Score
Time frame: Total score at Baseline and at 6 months
This is a measure of emotion recognition ability. Scores range from 0-19. A higher score indicates better performance.
Ambiguous Intentions and Hostility Scale - Hostility and Aggression Total Scores
Time frame: Total score at Baseline and at 3 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.
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.
The Awareness of Social Inference Test Total Score for Part 3
Time frame: Total score at Baseline and at 3 months
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.
The Awareness of Social Inference Task Total Score on Part 3
Time frame: Total score at Baseline and at 6 months
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.
8 secondary outcomes
Social Skill Performance Assessment Total Score
Time frame: Total score at Baseline and at 3 months
Social Skill Performance Assessment Total Score
Time frame: Total score at Baseline and at 6 months
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
Time frame: Total score at Baseline and at 3 months
First Episode Social Functioning Scale Performance Total Score on Scales 1-7
Time frame: Total Score at Baseline and at 6 months
Mentoring and Communication Support Scale Subscale Total Scores
Time frame: Total scores at Baseline and at 3 months
Mentoring and Communication Support Scale Subscale Total Scores
Time frame: Total score at Baseline and at 6 month assessments
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Total Scores
Time frame: Total score at Baseline and at 3 months
Vocational Efficacy in Trauma Survivors Scale Self Disclosure and Workplace Coping Subscale Total Scores
Time frame: Total score at Baseline and at 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tasha M Nienow, PhD principal investigator
Minneapolis Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition and Intervention Training in people with Schizophrenia and Bipolar Disorder, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bell-Lysaker Emotion Recognition Task Total Score (time frame: Total score at Baseline and 3 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.