RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness (RCT SCIT)
Primary Purpose
Mental Disorders
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
SCIT
TAFT
Sponsored by
About this trial
This is an interventional supportive care trial for Mental Disorders focused on measuring severe mental illness, social cognition, intervention
Eligibility 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
Sites / Locations
- Abarbanel center for mental health
- Summit rehabilitation center
- Shel Organization
- Enosh
- Keeneret
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
SCIT
TAFT
TAU
Arm Description
Social Cognition and Interaction Training: psychosocial group intervention
Therapeutic Alliance Focused Therapy
Treatment as Usual
Outcomes
Primary Outcome Measures
Wisconsin Social Quality of Life Scale.
questionnaire
The Face Emotion Identification Task
questionnaire
Faux-Pas task
questionnaire
Ambiguous Intentions Hostility Questionnaire
questionnaire
Social Skill Performance Assessment
verbal role-play assessment
Secondary Outcome Measures
The Working Alliance Inventory
questionnaire
narrative evaluation of intervention interview
open ended interview
Full Information
NCT ID
NCT02380885
First Posted
March 1, 2015
Last Updated
July 14, 2019
Sponsor
Bar-Ilan University, Israel
Collaborators
University of Haifa, Israel Science Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02380885
Brief Title
RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
Acronym
RCT SCIT
Official Title
Randomized Controlled Trial of Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2015 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bar-Ilan University, Israel
Collaborators
University of Haifa, Israel Science Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders
Keywords
severe mental illness, social cognition, intervention
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
158 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCIT
Arm Type
Experimental
Arm Description
Social Cognition and Interaction Training: psychosocial group intervention
Arm Title
TAFT
Arm Type
Experimental
Arm Description
Therapeutic Alliance Focused Therapy
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
SCIT
Other Intervention Name(s)
Social Cognition and Interaction Training
Intervention Description
psychosocial group intervention
Intervention Type
Behavioral
Intervention Name(s)
TAFT
Other Intervention Name(s)
Therapeutic Alliance Focused Therapy
Intervention Description
psychosocial group intervention
Primary Outcome Measure Information:
Title
Wisconsin Social Quality of Life Scale.
Description
questionnaire
Time Frame
5 min
Title
The Face Emotion Identification Task
Description
questionnaire
Time Frame
5 min
Title
Faux-Pas task
Description
questionnaire
Time Frame
10 min
Title
Ambiguous Intentions Hostility Questionnaire
Description
questionnaire
Time Frame
5 min
Title
Social Skill Performance Assessment
Description
verbal role-play assessment
Time Frame
15 min
Secondary Outcome Measure Information:
Title
The Working Alliance Inventory
Description
questionnaire
Time Frame
5 min
Title
narrative evaluation of intervention interview
Description
open ended interview
Time Frame
20 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilanit Hasson-Ohayon
Organizational Affiliation
Department of Psychology, Bar-Ilan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abarbanel center for mental health
City
Bat-Yam
ZIP/Postal Code
59624
Country
Israel
Facility Name
Summit rehabilitation center
City
Jerusalem
ZIP/Postal Code
91101
Country
Israel
Facility Name
Shel Organization
City
Petah-Tikva
Country
Israel
Facility Name
Enosh
City
Tel-Aviv
Country
Israel
Facility Name
Keeneret
City
Tiberias
ZIP/Postal Code
5290002
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
31244686
Citation
Hasson-Ohayon I, Mashiach-Eizenberg M, Lavi-Rotenberg A, Roe D. Randomized Controlled Trial of Adjunctive Social Cognition and Interaction Training, Adjunctive Therapeutic Alliance Focused Therapy, and Treatment As Usual Among Persons With Serious Mental Illness. Front Psychiatry. 2019 Jun 11;10:364. doi: 10.3389/fpsyt.2019.00364. eCollection 2019.
Results Reference
derived
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RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
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