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| Name | Class |
|---|---|
| University of Haifa | OTHER |
| Israel Science Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Cognition and Interaction Trainin | Experimental | Social Cognition and Interaction Training: psychosocial group intervention |
|
| Therapeutic Alliance Focused Therapy | Experimental | Therapeutic Alliance Focused Therapy |
|
| Treatment as Usual | No Intervention | Treatment as Usual |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCIT | Behavioral | psychosocial group intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention). |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilanit Hasson-Ohayon | Department of Psychology, Bar-Ilan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abarbanel center for mental health | Bat Yam | 59624 | Israel | |||
| Summit rehabilitation center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31244686 | Derived | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | SCIT | Social Cognition and Interaction Training: psychosocial group intervention SCIT: psychosocial group intervention |
| FG001 | TAFT | Therapeutic Alliance Focused Therapy TAFT: psychosocial group intervention |
| FG002 | TAU Group | Treatment as Usual |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCIT | Social Cognition and Interaction Training: psychosocial group intervention SCIT: psychosocial group intervention |
| BG001 | TAFT | Therapeutic Alliance Focused Therapy TAFT: psychosocial group intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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) | Posted | Mean | Standard Deviation | score on a scale | This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention). |
|
2 years.
the definition of adverse event and/or serious adverse event does not differ from the clinicaltrials.gov Definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SCIT | Social Cognition and Interaction Training: psychosocial group intervention SCIT: psychosocial group intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Ilanit Hasson-Ohayon | Bar-Ilan University | +972-3-5317673 | ilanithasson@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2024 | Apr 13, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| TAFT | Behavioral | psychosocial group intervention |
|
|
| 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). |
| Jerusalem |
| 91101 |
| Israel |
| Shel Organization | Petah Tikva | Israel |
| Enosh | Tel Aviv | Israel |
| Keeneret | Tiberias | 5290002 | Israel |
| BG002 | TAU Group | Treatment as Usual |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| The Face Emotion Identification Task (FEIT) | Mean | Full Range | units on a scale |
|
| TAFT |
Therapeutic Alliance Focused Therapy TAFT: psychosocial group intervention |
| OG002 | TAU Group | Treatment as Usual |
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention). |
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention). |
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention). |
|
|
|
| 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. | 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) | Posted | Mean | Standard Deviation | score on a scale | This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention). |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | TAFT | Therapeutic Alliance Focused Therapy TAFT: psychosocial group intervention | 0 | 20 | 0 | 20 | 0 | 20 |
| EG002 | TAU - Treatment as Usual | Treatment as Usual | 0 | 20 | 0 | 20 | 0 | 20 |
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|
| Intentionality score - pre |
|
| Intentionality score - post |
|
| Anger score - pre |
|
| Anger score - post |
|
| Blame score - pre |
|
| Blame score - post |
|
|
|