- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02134418
Evaluation of Social Skills Intervention on Cognitive Function in Schizophrenia
Evaluation of an Intervention Program Designed to Improve Understanding of Irony on the Hemispheric Processing of Ambiguous Figurative Language in Adults With Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dror Dolfin
- Phone Number: 972505406993
- Email: zdolfin@gmail.com
Study Locations
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-
Select your state
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Tel-Aviv, Select your state, Israel, 43562
- Brull- Tel Aviv Community Mental Health Center
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Contact:
- Dror Dolfin
- Phone Number: 972505406993
- Email: zdolfin@gmail.com
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Principal Investigator:
- Dror Dolfin, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- People suffering from any disabilities or handicap which limits their judgment
- With a guardian
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No Intervention
|
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EXPERIMENTAL: Irony CBT training
CBT of irony comprehension
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improved theory of mind abilities
Time Frame: 2 months
|
The Hinting Task used to measure TOM in Schizophrenia will be used before and after the intervention (Corcoran et al.1995)
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dror Dolfin, MD, Clalit Health Services
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0126-13-COM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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