- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02380885
RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness (RCT SCIT)
July 14, 2019 updated by: Ilanit Hasson-Ohayon, Bar-Ilan University, Israel
Randomized Controlled Trial of Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
The study evaluates the effectiveness of the social cognition and interaction training (SCIT), in comparison to both therapeutic alliance focused therapy (TAFT) and treatment as usual (TAU) among persons with severe mental illness.
Study purpose: 1) Assess the effectiveness of the SCIT and TAFT interventions, 2) Assess the processes that putatively contribute to the SCIT and TAFT outcomes.
Method: A Randomized Controlled Trial (RCT) with approximately one hundred and fifty persons with severe mental illness will be carried out in different psychiatric rehabilitation units and clinics in Israel.
To assess the relative effectiveness of the SCIT and TAFT interventions with persons with severe mental illness, both interventions will be compared to treatment as usual (TAU).
Clinicians will be trained in both interventions, and outcome measures, including social quality of life and social functioning, as well as mediating processes, including the identification of affective states, ToM, attribution errors and therapeutic alliance, will be assessed.
Cognitive functioning and symptom severity will be treated as covariates.
Statistical analyses will include analysis of variance which takes into consideration attrition, effect size, mediation processes and covariates.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Social cognition has become an important treatment target for people with schizophrenia since it has been found to be a strong predictor of functional outcome.
Social Cognition and Interaction Training (SCIT) is a manualized, group-based intervention that was developed to address the three core deficits in social cognition associated with severe mental illness: emotion perception, Theory of Mind (ToM), and attributional style.
SCIT has demonstrated efficacy in improving social cognition and social functioning in both inpatient and outpatient samples.
In addition, evidence also shows that the therapeutic alliance is related to various treatment outcomes.
Thus, both the SCIT and a therapeutic alliance focused therapy (TAFT) may both affect social cognition and social function, but through different pathways.
TAFT was chosen, as comparison to the SCIT, in order to control for interpersonal relationship variables.
In this way, the proposed study will evaluate empirically whether the specific techniques for ameliorating the social cognition of persons with severe mental illness that make-up the SCIT enhance social functioning beyond what is achieved through the effective interpersonal ingredients of the therapeutic alliance.
Study purpose: 1) Assess the effectiveness of the SCIT and TAFT interventions, 2) Assess the processes that putatively contribute to the SCIT and TAFT outcomes.
Method: A Randomized Controlled Trial (RCT) with one hundred and fifty persons with severe mental illness will be carried out in different psychiatric rehabilitation units and clinics in Israel.
To assess the relative effectiveness of the SCIT and TAFT interventions with persons with severe mental illness, both interventions will be compared to treatment as usual (TAU).
Clinicians will be trained in both interventions, and outcome measures, including social quality of life and social functioning, as well as mediating processes, including the identification of affective states, ToM, attribution errors and therapeutic alliance, will be assessed.
Cognitive functioning and symptom severity will be treated as covariates.
Statistical analyses will include analysis of variance which takes into consideration attrition, effect size, mediation processes and covariates.
Study Type
Interventional
Enrollment (Actual)
158
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bat-Yam, Israel, 59624
- Abarbanel center for mental health
-
Jerusalem, Israel, 91101
- Summit rehabilitation center
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Petah-Tikva, Israel
- Shel Organization
-
Tel-Aviv, Israel
- Enosh
-
Tiberias, Israel, 5290002
- Keeneret
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
- diagnosis of severe mental disorders (schizophrenia, schizoaffective, bi-polar, depression), * ability to provide informed consent
- ability to read and write in Hebrew
- no co-morbid nuerological condition
- no hospitalization in the last 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SCIT
Social Cognition and Interaction Training: psychosocial group intervention
|
psychosocial group intervention
Other Names:
|
Experimental: TAFT
Therapeutic Alliance Focused Therapy
|
psychosocial group intervention
Other Names:
|
No Intervention: TAU
Treatment as Usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wisconsin Social Quality of Life Scale.
Time Frame: 5 min
|
questionnaire
|
5 min
|
The Face Emotion Identification Task
Time Frame: 5 min
|
questionnaire
|
5 min
|
Faux-Pas task
Time Frame: 10 min
|
questionnaire
|
10 min
|
Ambiguous Intentions Hostility Questionnaire
Time Frame: 5 min
|
questionnaire
|
5 min
|
Social Skill Performance Assessment
Time Frame: 15 min
|
verbal role-play assessment
|
15 min
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Working Alliance Inventory
Time Frame: 5 min
|
questionnaire
|
5 min
|
narrative evaluation of intervention interview
Time Frame: 20 min
|
open ended interview
|
20 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ilanit Hasson-Ohayon, Department of Psychology, Bar-Ilan University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
July 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
March 1, 2015
First Submitted That Met QC Criteria
March 1, 2015
First Posted (Estimate)
March 5, 2015
Study Record Updates
Last Update Posted (Actual)
July 16, 2019
Last Update Submitted That Met QC Criteria
July 14, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCIT3C
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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