SchizophreniaNCT02134418
Evaluation of Social Skills Intervention on Cognitive Function in Schizophrenia
A study testing CBT of irony comprehension in people with Schizophrenia, run by Clalit Health Services at 1 site in Israel.
Trial summary
Intervention aimed at improving understanding of irony in social situations by using movies and comic strip will improve theory of mind. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CBT of irony comprehension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2015to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Schizophrenia
- Native Hebrew speakers
- Right handed ( subjects report)
- Without learning difficulties and who have completed 12 years of schooling (subjects report)
- Without neurological disorders ( subjects report)
- Normal or corrected to normal vision ( subjects report)
Who cannot join
- People suffering from any disabilities or handicap which limits their judgment
- With a guardian
Trial locations and contacts
1 site in 1 country.
Israel1 site
Brull- Tel Aviv Community Mental Health Center
Tel Aviv, Select Your State, 43562
Dror Dolfin, 972505406993, zdolfin@gmail.com
Dror Dolfin, MD
About this study
Official title: Evaluation of an Intervention Program Designed to Improve Understanding of Irony on the Hemispheric Processing of Ambiguous Figurative Language in Adults With Schizophrenia
Intervention aimed at improving understanding of irony in social situations by using movies and comic strip will improve theory of mind.
Read the detailed description
The overreaching goal of this study is to examine the influence of short CBT of irony comprehension on hemispheric involvement of adults with Schizophrenia. To obtain this goal a three phase study have been designed.
In the first phase all participants will be asked to fill out questionnaires screening for, cognitive abilities (TONI-3 third edition), vocabulary (Hebrew adaptation of Wechsler Adult Intelligence Scale-Third Edition, WAIS 3 HEB, Wechsler 1997), executive function capabilities and figurative language understanding (irony and metaphor) .Theory of Mind comprehension will also be assessed by using The Hinting Test (Corcoran et al.1995).
Hemispheric processing will be examined by two behavioral hemispheric experiments using split visual field paradigm. The subject sits in front of a computer screen, reads a prime sentence, and reacts to a lateralized target word.
In the first experiment- Idioms experiment, the target word in each trail would be related to the meaning of a preceding prime idiom or associated to its literal meaning .The participant is instructed to indicate as rapidly and accurately as possible whether the target word stimulus is a meaningful word or non- word. In the second experiment- irony experiment, the target word in each trail would be a literal, ironic or unrelated ending to the preceding prime sentence .Subjects would be asked to relate to the target word and to indicate as rapidly and accurately as possible whether the target word stimulus formed a meaningful expression with the preceding prime. Stimulus presentation and response would be controlled and recorded by Super-Lab 4.5 software.
The first phase will be carried out in 1-2 sessions.
In the second phase subjects will participate in a social intervention program for comprehension of verbal irony. Over the course of intervention participants will analyze and discuss short film scenario's that end with an ironic statement, and will experience completing short scenario's that contain irony. Intervention will include 5 sessions, 3-5 subjects will participate in each group.
In the third phase participants will undergo the Irony behavioral hemispheric experiment to examine changes in hemispheric processing when exposed to irony after treatment, the irony and metaphor questioners and the Hinting test. This phase will be carried out in one session.
35 subjects will participate in the study, 20 in the study group and 15 in the control group.
Subjects in the control group will watch the short film scenario's that end with an ironic statement and rank each video for its comprehensibility and their level of enjoyment.
- Conditions
- Schizophrenia
- Being tested
- CBT of irony comprehension
- Keywords
- Schizophrenia, Irony, Hemispheric processing, Theory of mind
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT of irony comprehensionBehavioural
Over the course of intervention participants will analyze and discuss short film scenario's that end with an ironic statement, and will experience completing short scenario's that contain irony. Intervention will include 5 sessions, each session will take 40 minutes, 3-5 subjects will participate in each group.
| Study group | Role | What they receive |
|---|---|---|
| Irony CBT training | Experimental | CBT of irony comprehension Receives: Behavioral: CBT of irony comprehension |
| No Intervention | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irony behavioral hemispheric results
Changes in the response time and accuracy percentage of each hemisphere in the irony behavioral hemispheric experiment.
Measured: 2 months
Secondary outcomes (1)
Improved theory of mind abilities
The Hinting Task used to measure TOM in Schizophrenia will be used before and after the intervention (Corcoran et al.1995)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies 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
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clalit Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dror Dolfin, MD, Principal investigator, Clalit Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134418
- Sponsor's protocol ID
- 0126-13-COM
- Status last verified
- Feb 2015
- First submitted
- 30 Apr 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention Program Designed to Improve Understanding of Irony on the Hemispheric Processing of Ambiguous Figurative Language in Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT02134418
- Acronym / sponsor ID
- 0126-13-COM
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Irony, Hemispheric processing, Theory of mind
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Clalit Health ServicesUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intervention aimed at improving understanding of irony in social situations by using movies and comic strip will improve theory of mind.
Detailed description
The overreaching goal of this study is to examine the influence of short CBT of irony comprehension on hemispheric involvement of adults with Schizophrenia. To obtain this goal a three phase study have been designed.
In the first phase all participants will be asked to fill out questionnaires screening for, cognitive abilities (TONI-3 third edition), vocabulary (Hebrew adaptation of Wechsler Adult Intelligence Scale-Third Edition, WAIS 3 HEB, Wechsler 1997), executive function capabilities and figurative language understanding (irony and metaphor) .Theory of Mind comprehension will also be assessed by using The Hinting Test (Corcoran et al.1995).
Hemispheric processing will be examined by two behavioral hemispheric experiments using split visual field paradigm. The subject sits in front of a computer screen, reads a prime sentence, and reacts to a lateralized target word.
In the first experiment- Idioms experiment, the target word in each trail would be related to the meaning of a preceding prime idiom or associated to its literal meaning .The participant is instructed to indicate as rapidly and accurately as possible whether the target word stimulus is a meaningful word or non- word. In the second experiment- irony experiment, the target word in each trail would be a literal, ironic or unrelated ending to the preceding prime sentence .Subjects would be asked to relate to the target word and to indicate as rapidly and accurately as possible whether the target word stimulus formed a meaningful expression with the preceding prime. Stimulus presentation and response would be controlled and recorded by Super-Lab 4.5 software.
The first phase will be carried out in 1-2 sessions.
In the second phase subjects will participate in a social intervention program for comprehension of verbal irony. Over the course of intervention participants will analyze and discuss short film scenario's that end with an ironic statement, and will experience completing short scenario's that contain irony. Intervention will include 5 sessions, 3-5 subjects will participate in each group.
In the third phase participants will undergo the Irony behavioral hemispheric experiment to examine changes in hemispheric processing when exposed to irony after treatment, the irony and metaphor questioners and the Hinting test. This phase will be carried out in one session.
35 subjects will participate in the study, 20 in the study group and 15 in the control group.
Subjects in the control group will watch the short film scenario's that end with an ironic statement and rank each video for its comprehensibility and their level of enjoyment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Irony CBT training | Experimental | Behavioral: CBT of irony comprehensionCBT of irony comprehension |
| No Intervention | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of Schizophrenia
- Native Hebrew speakers
- Right handed ( subjects report)
- Without learning difficulties and who have completed 12 years of schooling (subjects report)
- Without neurological disorders ( subjects report)
Key exclusion criteria (2 listed)
- People suffering from any disabilities or handicap which limits their judgment
- With a guardian
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 |
|---|---|---|
| CBT of irony comprehensionOver the course of intervention participants will analyze and discuss short film scenario's that end with an ironic statement, and will experience completing short scenario's that contain irony. Intervention will include 5 sessions, each session will take 40 minutes, 3-5 subjects will participate in each group. | Behavioural | Irony CBT training |
Primary outcome
Irony behavioral hemispheric results
Time frame: 2 months
Changes in the response time and accuracy percentage of each hemisphere in the irony behavioral hemispheric experiment.
1 secondary outcome
Improved theory of mind abilities
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Dror Dolfin, MD principal investigator
Clalit Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT of irony comprehension in people with Schizophrenia, run by Clalit Health Services at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dror Dolfin (972505406993, zdolfin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irony behavioral hemispheric results (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2015.