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
      • 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:
  • Social Cognition and Interaction Training
Experimental: TAFT
Therapeutic Alliance Focused Therapy
psychosocial group intervention
Other Names:
  • Therapeutic Alliance Focused Therapy
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.

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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