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Evaluation of Social Skills Intervention on Cognitive Function in Schizophrenia

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ClinicalTrials.gov Identifier: NCT02134418
Recruitment Status : Unknown
Verified February 2015 by Clalit Health Services.
Recruitment status was:  Not yet recruiting
First Posted : May 9, 2014
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Clalit Health Services

Brief Summary:
Intervention aimed at improving understanding of irony in social situations by using movies and comic strip will improve theory of mind.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: CBT of irony comprehension Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : March 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Irony CBT training
CBT of irony comprehension
Behavioral: 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.

No Intervention: No Intervention
No Intervention



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134418


Contacts
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Contact: Dror Dolfin 972505406993 zdolfin@gmail.com

Locations
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Israel
Brull- Tel Aviv Community Mental Health Center
Tel-Aviv, Select your state, Israel, 43562
Contact: Dror Dolfin    972505406993    zdolfin@gmail.com   
Principal Investigator: Dror Dolfin, MD         
Sponsors and Collaborators
Clalit Health Services
Investigators
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Principal Investigator: Dror Dolfin, MD Clalit Health Services
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Responsible Party: Clalit Health Services
ClinicalTrials.gov Identifier: NCT02134418    
Other Study ID Numbers: 0126-13-COM
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by Clalit Health Services:
Schizophrenia
Irony
Hemispheric processing
Theory of mind
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders