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Evaluation of Social Skills Intervention on Cognitive Function in Schizophrenia

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
CBT of irony comprehension
Sponsored by
Clalit Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia focused on measuring Schizophrenia, Irony, Hemispheric processing, Theory of mind

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brull- Tel Aviv Community Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Irony CBT training

No Intervention

Arm Description

CBT of irony comprehension

No Intervention

Outcomes

Primary Outcome Measures

Irony behavioral hemispheric results
Changes in the response time and accuracy percentage of each hemisphere in the irony behavioral hemispheric experiment.

Secondary Outcome Measures

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)

Full Information

First Posted
April 30, 2014
Last Updated
February 3, 2015
Sponsor
Clalit Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT02134418
Brief Title
Evaluation of Social Skills Intervention on Cognitive Function in Schizophrenia
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 Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clalit Health Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Irony, Hemispheric processing, Theory of mind

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irony CBT training
Arm Type
Experimental
Arm Description
CBT of irony comprehension
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
CBT of irony comprehension
Intervention Description
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.
Primary Outcome Measure Information:
Title
Irony behavioral hemispheric results
Description
Changes in the response time and accuracy percentage of each hemisphere in the irony behavioral hemispheric experiment.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Improved theory of mind abilities
Description
The Hinting Task used to measure TOM in Schizophrenia will be used before and after the intervention (Corcoran et al.1995)
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dror Dolfin
Phone
972505406993
Email
zdolfin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Dolfin, MD
Organizational Affiliation
Clalit Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brull- Tel Aviv Community Mental Health Center
City
Tel-Aviv
State/Province
Select your state
ZIP/Postal Code
43562
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dror Dolfin
Phone
972505406993
Email
zdolfin@gmail.com
First Name & Middle Initial & Last Name & Degree
Dror Dolfin, MD

12. IPD Sharing Statement

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Evaluation of Social Skills Intervention on Cognitive Function in Schizophrenia

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