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RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness (RCT SCIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Ilanit Hasson-Ohayon, Bar-Ilan University, Israel
Sponsor:
Collaborators:
University of Haifa
Israel Science Foundation
Information provided by (Responsible Party):
Ilanit Hasson-Ohayon, Bar-Ilan University, Israel
ClinicalTrials.gov Identifier:
NCT02380885
First received: March 1, 2015
Last updated: July 20, 2016
Last verified: July 2016
  Purpose
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.

Condition Intervention
Mental Disorders
Behavioral: SCIT
Behavioral: TAFT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness

Resource links provided by NLM:


Further study details as provided by Ilanit Hasson-Ohayon, Bar-Ilan University, Israel:

Primary Outcome Measures:
  • Wisconsin Social Quality of Life Scale. [ Time Frame: 5 min ]
    questionnaire

  • The Face Emotion Identification Task [ Time Frame: 5 min ]
    questionnaire

  • Faux-Pas task [ Time Frame: 10 min ]
    questionnaire

  • Ambiguous Intentions Hostility Questionnaire [ Time Frame: 5 min ]
    questionnaire

  • Social Skill Performance Assessment [ Time Frame: 15 min ]
    verbal role-play assessment


Secondary Outcome Measures:
  • The Working Alliance Inventory [ Time Frame: 5 min ]
    questionnaire

  • narrative evaluation of intervention interview [ Time Frame: 20 min ]
    open ended interview


Estimated Enrollment: 120
Study Start Date: January 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCIT
Social Cognition and Interaction Training: psychosocial group intervention
Behavioral: SCIT
psychosocial group intervention
Other Name: Social Cognition and Interaction Training
Experimental: TAFT
Therapeutic Alliance Focused Therapy
Behavioral: TAFT
psychosocial group intervention
Other Name: Therapeutic Alliance Focused Therapy
No Intervention: TAU
Treatment as Usual

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02380885

Contacts
Contact: Ilanit Hasson-Ohayon, Prof. +97225318477 ilanithasson@gmail.com
Contact: Zach Gerber zgerber@gmail.com

Locations
Israel
Abarbanel center for mental health Terminated
Bat-Yam, Israel, 59624
Summit rehabilitation center Active, not recruiting
Jerusalem, Israel, 91101
Shel Organization Recruiting
Petah-Tikva, Israel
Contact: David Lochoff         
Keeneret Recruiting
Tiberia, Israel, 5290002
Contact: Ilanit Hasson-Ohayon    025318477    ilanithasson@gmail.com   
Contact: Yoval Taler       yuvaltaler@gmail.com   
Sponsors and Collaborators
Bar-Ilan University, Israel
University of Haifa
Israel Science Foundation
Investigators
Principal Investigator: Ilanit Hasson-Ohayon Department of Psychology, Bar-Ilan University
  More Information

Responsible Party: Ilanit Hasson-Ohayon, Prof. Ilanit Hasson-Ohayon, Bar-Ilan University, Israel
ClinicalTrials.gov Identifier: NCT02380885     History of Changes
Other Study ID Numbers: SCIT3C
Study First Received: March 1, 2015
Last Updated: July 20, 2016

Keywords provided by Ilanit Hasson-Ohayon, Bar-Ilan University, Israel:
severe mental illness
social cognition
intervention

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on May 25, 2017