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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02380885
Enrollment
158
Registered
2015-03-05
Start date
2015-01-31
Completion date
2018-07-31
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

Keywords

severe mental illness, social cognition, intervention

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.

Interventions

BEHAVIORALSCIT

psychosocial group intervention

BEHAVIORALTAFT

psychosocial group intervention

Sponsors

University of Haifa
CollaboratorOTHER
Israel Science Foundation
CollaboratorOTHER
Bar-Ilan University, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
The Face Emotion Identification Task (FEIT)This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).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).
Faux-Pas TaskThis outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).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.
Ambiguous Intentions Hostility Questionnaire (AIHQ)This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).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.
Social Skill Performance AssessmentThis outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).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.

Secondary

MeasureTime frameDescription
Wisconsin Social Quality of Life Scale.This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).The Wisconsin Quality of Life Scale (W-QLI) is a multidimensional assessment tool designed to measure quality of life, particularly for individuals with mental illness. The scores range from 0 to 7, with the higher score indicating higher social QoL.

Countries

Israel

Participant flow

Recruitment details

A total of 158 participants participated in the study (158 participants were randomized into three groups). Data were collected between the years 2014 and 2018 from four psychiatric rehabilitation agencies.

Participants by arm

ArmCount
SCIT
Social Cognition and Interaction Training: psychosocial group intervention SCIT: psychosocial group intervention
23
TAFT
Therapeutic Alliance Focused Therapy TAFT: psychosocial group intervention
20
TAU Group
Treatment as Usual
20
Total63

Baseline characteristics

CharacteristicTAFTTAU GroupTotalSCIT
Age, Customized
Age
41.4 years
STANDARD_DEVIATION 12.2
39.7 years
STANDARD_DEVIATION 9.4
39.94 years
STANDARD_DEVIATION 11
38.9 years
STANDARD_DEVIATION 11
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
20 Participants20 Participants63 Participants23 Participants
Region of Enrollment
Israel
20 participants20 participants63 participants23 participants
Sex/Gender, Customized
female
6 participants5 participants22 participants11 participants
Sex/Gender, Customized
male
14 participants15 participants41 participants12 participants
The Face Emotion Identification Task (FEIT)12.42 units on a scale11.55 units on a scale12.29 units on a scale12.83 units on a scale

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 230 / 200 / 20
other
Total, other adverse events
0 / 230 / 200 / 20
serious
Total, serious adverse events
0 / 230 / 200 / 20

Outcome results

Primary

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.

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

Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)

ArmMeasureGroupValue (MEAN)Dispersion
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Hostility bias - pre group intervention10.93 score on a scaleStandard Deviation 3.5
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Hostility bias - post group intervention10.19 score on a scaleStandard Deviation 2.34
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Intentionality score - pre12.49 score on a scaleStandard Deviation 3.31
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Intentionality score - post11.69 score on a scaleStandard Deviation 2.09
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Anger score - pre14.9 score on a scaleStandard Deviation 4.21
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Anger score - post13.53 score on a scaleStandard Deviation 3.39
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Blame score - pre14.29 score on a scaleStandard Deviation 4.09
SCITAmbiguous Intentions Hostility Questionnaire (AIHQ)Blame score - post13 score on a scaleStandard Deviation 3.61
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Intentionality score - pre12.58 score on a scaleStandard Deviation 4.66
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Blame score - pre14.16 score on a scaleStandard Deviation 5.92
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Intentionality score - post11.05 score on a scaleStandard Deviation 4.78
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Anger score - pre14.68 score on a scaleStandard Deviation 5.52
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Anger score - post12.47 score on a scaleStandard Deviation 5.64
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Hostility bias - pre group intervention12.63 score on a scaleStandard Deviation 4.2
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Hostility bias - post group intervention11.64 score on a scaleStandard Deviation 4.5
TAFTAmbiguous Intentions Hostility Questionnaire (AIHQ)Blame score - post13 score on a scaleStandard Deviation 5.73
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Intentionality score - pre12.42 score on a scaleStandard Deviation 3.76
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Hostility bias - post group intervention12.06 score on a scaleStandard Deviation 3.61
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Hostility bias - pre group intervention11.64 score on a scaleStandard Deviation 3.7
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Intentionality score - post12.30 score on a scaleStandard Deviation 2.96
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Blame score - pre13.05 score on a scaleStandard Deviation 4.5
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Anger score - post13.47 score on a scaleStandard Deviation 5.26
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Anger score - pre12.66 score on a scaleStandard Deviation 4.5
TAU GroupAmbiguous Intentions Hostility Questionnaire (AIHQ)Blame score - post13.63 score on a scaleStandard Deviation 4.42
Primary

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.

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

Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)

ArmMeasureGroupValue (MEAN)Dispersion
SCITFaux-Pas TaskPRE group intervention30.79 score on a scaleStandard Deviation 8.19
SCITFaux-Pas TaskPOST group intervention34.41 score on a scaleStandard Deviation 5.51
TAFTFaux-Pas TaskPRE group intervention30.11 score on a scaleStandard Deviation 6.84
TAFTFaux-Pas TaskPOST group intervention31.89 score on a scaleStandard Deviation 7.98
TAU GroupFaux-Pas TaskPRE group intervention27.95 score on a scaleStandard Deviation 8.11
TAU GroupFaux-Pas TaskPOST group intervention29.20 score on a scaleStandard Deviation 8.51
Primary

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.

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

Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)

ArmMeasureGroupValue (MEAN)Dispersion
SCITSocial Skill Performance AssessmentPRE group intervention47.13 score on a scaleStandard Deviation 13.3
SCITSocial Skill Performance AssessmentPOST group intervention52.39 score on a scaleStandard Deviation 16.6
TAFTSocial Skill Performance AssessmentPRE group intervention48.90 score on a scaleStandard Deviation 13.4
TAFTSocial Skill Performance AssessmentPOST group intervention50.20 score on a scaleStandard Deviation 12.7
TAU GroupSocial Skill Performance AssessmentPRE group intervention54 score on a scaleStandard Deviation 16
TAU GroupSocial Skill Performance AssessmentPOST group intervention49.70 score on a scaleStandard Deviation 16.2
Primary

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).

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

Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)

ArmMeasureGroupValue (MEAN)Dispersion
SCITThe Face Emotion Identification Task (FEIT)PRE group intervention12.83 score on a scaleStandard Deviation 2.86
SCITThe Face Emotion Identification Task (FEIT)POST group intervention13.65 score on a scaleStandard Deviation 2.71
TAFTThe Face Emotion Identification Task (FEIT)PRE group intervention12.47 score on a scaleStandard Deviation 3.71
TAFTThe Face Emotion Identification Task (FEIT)POST group intervention13.65 score on a scaleStandard Deviation 3.45
TAU GroupThe Face Emotion Identification Task (FEIT)PRE group intervention11.55 score on a scaleStandard Deviation 3.2
TAU GroupThe Face Emotion Identification Task (FEIT)POST group intervention12.00 score on a scaleStandard Deviation 3.73
Secondary

Wisconsin Social Quality of Life Scale.

The Wisconsin Quality of Life Scale (W-QLI) is a multidimensional assessment tool designed to measure quality of life, particularly for individuals with mental illness. The scores range from 0 to 7, with the higher score indicating higher social QoL.

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

Population: Each participant underwent a baseline evaluation prior to his participation of one of the groups (=PRE group), and underwent another evaluation at the end of the group intervention (=POST group, at 6 months)

ArmMeasureGroupValue (MEAN)Dispersion
SCITWisconsin Social Quality of Life Scale.PRE group intervention4.48 score on a scaleStandard Deviation 1.22
SCITWisconsin Social Quality of Life Scale.POST group intervention4.61 score on a scaleStandard Deviation 1.31
TAFTWisconsin Social Quality of Life Scale.PRE group intervention5.22 score on a scaleStandard Deviation 1.35
TAFTWisconsin Social Quality of Life Scale.POST group intervention5.23 score on a scaleStandard Deviation 1.53
TAU GroupWisconsin Social Quality of Life Scale.PRE group intervention4.78 score on a scaleStandard Deviation 1.4
TAU GroupWisconsin Social Quality of Life Scale.POST group intervention4.77 score on a scaleStandard Deviation 1.32

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026