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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

Tracking Information
First Submitted Date  ICMJE April 30, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date February 4, 2015
Study Start Date  ICMJE March 2015
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2014)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Social Skills Intervention on Cognitive Function in Schizophrenia
Official Title  ICMJE Evaluation of an Intervention Program Designed to Improve Understanding of Irony on the Hemispheric Processing of Ambiguous Figurative Language in Adults With Schizophrenia
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Schizophrenia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Irony CBT training
    CBT of irony comprehension
    Intervention: Behavioral: CBT of irony comprehension
  • No Intervention: No Intervention
    No Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2014)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134418
Other Study ID Numbers  ICMJE 0126-13-COM
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clalit Health Services
Study Sponsor  ICMJE Clalit Health Services
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dror Dolfin, MD Clalit Health Services
PRS Account Clalit Health Services
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP