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

Mental Disorders Clinical Trial

— RCT SCIT  

Official title:

Randomized Controlled Trial of Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380885
• Other study ID #: SCIT3C
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: July 2018

Study information

• Verified date: July 2019
• Source: Bar-Ilan University, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• SCIT
psychosocial group intervention
• TAFT
psychosocial group intervention

Locations

Country	Name	City	State
Israel	Abarbanel center for mental health	Bat-Yam
Israel	Summit rehabilitation center	Jerusalem
Israel	Shel Organization	Petah-Tikva
Israel	Enosh	Tel-Aviv
Israel	Keeneret	Tiberias

Sponsors (3)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel	Israel Science Foundation, University of Haifa

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wisconsin Social Quality of Life Scale.	questionnaire	5 min
Primary	The Face Emotion Identification Task	questionnaire	5 min
Primary	Faux-Pas task	questionnaire	10 min
Primary	Ambiguous Intentions Hostility Questionnaire	questionnaire	5 min
Primary	Social Skill Performance Assessment	verbal role-play assessment	15 min
Secondary	The Working Alliance Inventory	questionnaire	5 min
Secondary	narrative evaluation of intervention interview	open ended interview	20 min