Clinical trial NCT02380885: RCT Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
Official title: Randomized Controlled Trial of Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorders
Keywords: severe mental illness
social cognition
intervention
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
Collaborators: name: University of Haifa
name: Israel Science Foundation
First posted: 2015-03-05
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion criteria:

* Diagnosis of severe mental disorders (schizophrenia, schizoaffective, bi-polar, depression).
* Ability to provide informed consent.
* Ability to read and write in Hebrew.

Exclusion criteria:

* Co-morbid nuerological condition.
* Hospitalization in the last 6 months.

Primary outcomes:
measure: The Face Emotion Identification Task (FEIT)
timeFrame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).
measure: Faux-Pas Task
timeFrame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).
measure: Ambiguous Intentions Hostility Questionnaire (AIHQ)
timeFrame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).
measure: Social Skill Performance Assessment
timeFrame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).
Secondary outcomes:
measure: Wisconsin Social Quality of Life Scale.
timeFrame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).
Other outcomes:
Locations:
city: Bat-Yam
country: Israel
facility: Abarbanel center for mental health
city: Jerusalem
country: Israel
facility: Summit rehabilitation center
city: Petah-Tikva
country: Israel
facility: Shel Organization
city: Tel-Aviv
country: Israel
facility: Enosh
city: Tiberias
country: Israel
facility: Keeneret
Study officials:
affiliation: Department of Psychology, Bar-Ilan University
name: Ilanit Hasson-Ohayon
role: PRINCIPAL_INVESTIGATOR
References:
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.