Mental DisordersNCT02380885

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

A study testing SCIT and TAFT in people with Mental Disorders, run by Bar-Ilan University, Israel at 5 sites in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Mental Disorders
What is being tested?: SCIT and TAFT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 5 sitesIsrael
Study dates: Jan 2015to Jul 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Israel5 sites

Abarbanel center for mental health
Bat Yam, 59624
Summit rehabilitation center
Jerusalem, 91101
Shel Organization
Petah Tikva
Enosh
Tel Aviv
Keeneret
Tiberias, 5290002

Other trials in Israel

About this study

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

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.

Read the 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.

Conditions: Mental Disorders
Being tested: SCIT, TAFT
Keywords: severe mental illness, social cognition, intervention
Medical subject headings: Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCITBehavioural
Also called Social Cognition and Interaction Training
psychosocial group intervention
TAFTBehavioural
Also called Therapeutic Alliance Focused Therapy
psychosocial group intervention

Study groups in NCT02380885
Study group	Role	What they receive
Social Cognition and Interaction Trainin	Experimental	Social Cognition and Interaction Training: psychosocial group intervention Receives: Behavioral: SCIT
Therapeutic Alliance Focused Therapy	Experimental	Therapeutic Alliance Focused Therapy Receives: Behavioral: TAFT
Treatment as Usual	No intervention	Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2015Jul 2018

First posted5 Mar 2015 (estimated)
Study startJan 2015
Primary completionJul 2018
Study completionJul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Mental DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02380885
Sponsor's protocol ID: SCIT3C
Status last verified: Mar 2025
First submitted: 1 Mar 2015
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 31244686

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Social Cognition Training and Therapeutic Alliance Focused Therapy for Persons With Severe Mental Illness
ClinicalTrials.gov ID: NCT02380885
Acronym / sponsor ID: SCIT3C
Conditions: Mental Disorders
Keywords: severe mental illness, social cognition, intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: Bar-Ilan University, IsraelUniversity, hospital or other
Collaborators: University of Haifa, Israel Science Foundation
Study start: Jan 2015 (actual)
Primary completion: Jul 2018 (actual)
Study completion: Jul 2018 (actual)
First posted: 5 Mar 2015 (estimated)
Results: Posted 6 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Social Cognition and Interaction Trainin	Experimental	Behavioral: SCITSocial Cognition and Interaction Training: psychosocial group intervention
Therapeutic Alliance Focused Therapy	Experimental	Behavioral: TAFTTherapeutic Alliance Focused Therapy
Treatment as Usual	No intervention	–Treatment as Usual

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCITAlso: Social Cognition and Interaction Trainingpsychosocial group intervention	Behavioural	Social Cognition and Interaction Trainin
TAFTAlso: Therapeutic Alliance Focused Therapypsychosocial group intervention	Behavioural	Therapeutic Alliance Focused Therapy

Primary outcome

The Face Emotion Identification Task (FEIT)
Time frame: 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 Task
Time frame: This 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)
Time frame: 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 Assessment
Time frame: This 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.

1 secondary outcome

Wisconsin Social Quality of Life Scale.
Time frame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).

Results and safety

Results posted to the registry on 6 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCIT	62	23
TAFT	58	20
TAU Group	38	20

Primary outcome: The Face Emotion Identification Task (FEIT)

Time frame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).. Mean (Standard Deviation). Unit: score on a scale

Measure	SCIT n = 23	TAFT n = 20	TAU Group n = 20
PRE group intervention	12.83 (2.86)	12.47 (3.71)	11.55 (3.20)
POST group intervention	13.65 (2.71)	13.65 (3.45)	12.00 (3.73)

Population analysed: 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)

Primary outcome: Faux-Pas Task

Time frame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).. Mean (Standard Deviation). Unit: score on a scale

Measure	SCIT n = 23	TAFT n = 20	TAU Group n = 20
PRE group intervention	30.79 (8.19)	30.11 (6.84)	27.95 (8.11)
POST group intervention	34.41 (5.51)	31.89 (7.98)	29.20 (8.51)

Primary outcome: Ambiguous Intentions Hostility Questionnaire (AIHQ)

Time frame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).. Mean (Standard Deviation). Unit: score on a scale

Measure	SCIT n = 23	TAFT n = 20	TAU Group n = 20
Hostility bias - pre group intervention	10.93 (3.50)	12.63 (4.20)	11.64 (3.70)
Hostility bias - post group intervention	10.19 (2.34)	11.64 (4.50)	12.06 (3.61)
Intentionality score - pre	12.49 (3.31)	12.58 (4.66)	12.42 (3.76)
Intentionality score - post	11.69 (2.09)	11.05 (4.78)	12.30 (2.96)
Anger score - pre	14.9 (4.21)	14.68 (5.52)	12.66 (4.50)
Anger score - post	13.53 (3.39)	12.47 (5.64)	13.47 (5.26)
Blame score - pre	14.29 (4.09)	14.16 (5.92)	13.05 (4.50)
Blame score - post	13 (3.61)	13 (5.73)	13.63 (4.42)

Primary outcome: Social Skill Performance Assessment

Time frame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).. Mean (Standard Deviation). Unit: score on a scale

Measure	SCIT n = 23	TAFT n = 20	TAU Group n = 20
PRE group intervention	47.13 (13.3)	48.90 (13.4)	54 (16)
POST group intervention	52.39 (16.6)	50.20 (12.7)	49.70 (16.2)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 2 years.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SCIT	0 of 23 (0%)	0 of 23 (0%)	0 of 23
TAFT	0 of 20 (0%)	0 of 20 (0%)	0 of 20
TAU - Treatment as Usual	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31244686Hasson-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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ilanit Hasson-Ohayon principal investigator

Department of Psychology, Bar-Ilan University

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SCIT and TAFT in people with Mental Disorders, run by Bar-Ilan University, Israel at 5 sites in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Face Emotion Identification Task (FEIT) (time frame: This outcome measure was assessed at baseline (Pre-intervention) and at 6 months later (Post-intervention).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02380885, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.