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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Other trials in United States

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:

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 groups in NCT02663349
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.

Jan 2016Jul 2019

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

All Schizophrenia trials

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.

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.

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

Results posted to the registry on 23 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Supported SCIT	22	16

Primary outcome: Bell-Lysaker Emotion Recognition Task Total Score

Time frame: Total score at Baseline and 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Supported SCIT n = 15
Baseline	14.8 (3.10)
3 month assessment	16.00 (2.42)

Supported SCIT: p = .08, t-test, 2 sided

Population analysed: One participant produced invalid results on this measure and their data was removed

Primary outcome: Bell-Lysaker Emotion Recognition Task Total Score

Time frame: Total score at Baseline and at 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Supported SCIT n = 15
Baseline	14.8 (3.10)
6 month assessment	15.13 (3.27)

Supported SCIT: p = .69, t-test, 2 sided

Population analysed: One participant produced invalid results on this measure and their data was removed

Primary outcome: Facial Emotion Identification Test Total Score

Time frame: Total score at Baseline and at 3 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Supported SCIT n = 15
Baseline Assessment	12.20 (3.26)
3-month Assessment	13.8 (2.60)

Supported SCIT: p = .02, t-test, 2 sided

Population analysed: completer analysis, Scores for one participant were removed for this measure due to invalid performance.

Primary outcome: Facial Emotion Identification Test Total Score

Time frame: Total score at Baseline and at 6 months. Mean (Standard Deviation). Unit: score on a scale

Measure	Supported SCIT n = 15
Baseline Assessment	12.20 (3.26)
6 Month Assessment	12.4 (3.07)

Supported SCIT: p = .34, t-test, 2 sided

Population analysed: completer analysis, Scores from one participant were removed from this analysis due to invalid performance.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: For each participant, adverse event data were collected through study completion, an average of 8 months for each participant.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Supported SCIT	0 of 22 (0%)	0 of 22 (0%)	0 of 22

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

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

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?

On the ClinicalTrials.gov record for NCT02663349.

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.