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

NCT02380885 | Completed Results

• 1 other identifier: SCIT3C
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 5

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.

Conditions

Mental Disorders

Keywords

severe mental illness; social cognition; intervention

Outcome Measures

Primary Outcomes (4)

• The Face Emotion Identification Task (FEIT)

  A widely used measure of emotion perception and is indexed by the total number of correctly identified emotions out of nineteen pictured faces (higher number indicates better emotion identification).

  This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).

• Faux-Pas Task

  The Faux Pas Task is a social cognition assessment tool that measures the ability to detect and understand social faux pas - situations where someone says something they shouldn't have said because they didn't know or realize certain information. Faux-Pas task in its Hebrew version (Shamay-Tsoory, Tomer, Berger, Goldsher, \& Aharon-Peretz, 2005) was used to assess TOM. It consist of 10 stories in which a faux pas has occurred and 10 control stories. It assesses emotional and cognitive attributions and the score for each story ranged between 0 to 7. After each story the participants are asked six questions regarding the recognition of faux-pas (understanding the mental state of speaker and listener, understanding the emotional state of the listener). The total score ranges from 0 to 70, when higher scores indicate better ability to detect social mistakes.

  This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).

• Ambiguous Intentions Hostility Questionnaire (AIHQ)

  The AIHQ is a measure of attributional style for situations with negative outcomes and ambiguous causality. Participants are asked to read each of five vignettes, to imagine that the scenario is happening to her or him, and to write down the reason why the other person acted the way he did toward the participant. Two independent raters subsequently code this written response for the purpose of computing a "hostility bias." The participant then rates the degree to which he or she thinks the other person performed the action on purpose, how angry this action would make the participant feel, and how much the participant would blame the other person. Four scales that are calculated: Hostility Bias, Blame Score, Aggression Bias, Intentionality Bias (each is a 5-point Likert scale) . In the total scores, each scale can be range from 0 (min) to 25 (max), with higher scores indicating greater attribution of hostile intent, blame, or aggressive response tendencies.

  This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).

• Social Skill Performance Assessment

  The SSPA is a verbal role-play assessment in which the subject participates in two 3-minute role-play conversations ("scenes") with the assessor on pre-determined topics (e.g. "Your landlord has not fixed a leak that you told him about last week, and now you are calling him on the phone to follow-up."). Role-plays are tape-recorded and rated by independent coders. Each one of the 17 domains is rated on a 5-point Likert-type scale. Thus, the total score for the task can be ranged from 0 (min) to 85 (max), with higher scores signifying greater social skills. The SSPA has good face validity as a social skill measure and among individuals with schizophrenia it shown excellent inter-rater reliability, good test-retest reliability, and good convergent validity with a measure of activities of daily living. It is a 5-point Likert-type scale with higher scores signifying greater social skill.

  This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).

Secondary Outcomes (1)

• Wisconsin Social Quality of Life Scale.

  This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).

Study Arms (3)

Social Cognition and Interaction Trainin

EXPERIMENTAL

Social Cognition and Interaction Training: psychosocial group intervention

Behavioral: SCIT

Therapeutic Alliance Focused Therapy

EXPERIMENTAL

Therapeutic Alliance Focused Therapy

Behavioral: TAFT

Treatment as Usual

NO INTERVENTION

Treatment as Usual

Interventions

SCIT BEHAVIORAL

psychosocial group intervention

Also known as: Social Cognition and Interaction Training

Social Cognition and Interaction Trainin

TAFT BEHAVIORAL

psychosocial group intervention

Also known as: Therapeutic Alliance Focused Therapy

Therapeutic Alliance Focused Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead
• University of Haifa: collaborator
• Israel Science Foundation: collaborator

Study Sites (5)

Abarbanel center for mental health

Bat Yam, 59624, Israel

Location

Summit rehabilitation center

Jerusalem, 91101, Israel

Location

Shel Organization

Petah Tikva, Israel

Location

Enosh

Tel Aviv, Israel

Location

Keeneret

Tiberias, 5290002, Israel

Location

Related Publications (1)

• 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.

  PMID: 31244686 DERIVED

MeSH Terms

Conditions

Mental Disorders

Results Point of Contact

• Title: Prof. Ilanit Hasson-Ohayon
• Organization: Bar-Ilan University

ilanithasson@gmail.com

+972-3-5317673

Study Officials

• Ilanit Hasson-Ohayon

  Department of Psychology, Bar-Ilan University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Ilanit Hasson-Ohayon

Study Record Dates

• First Submitted: March 1, 2015
• First Posted: March 5, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: March 6, 2025
• Results First Posted: March 6, 2025

Record last verified: 2025-03

Locations

IL (5)