NCT02134418

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for not_applicable schizophrenia

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 9, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1 year

First QC Date

April 30, 2014

Last Update Submit

February 3, 2015

Conditions

Schizophrenia

Keywords

SchizophreniaIronyHemispheric processingTheory of mind

Outcome Measures

Primary Outcomes (1)

  • Irony behavioral hemispheric results

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

    2 months

Secondary Outcomes (1)

  • Improved theory of mind abilities

    2 months

Study Arms (2)

Irony CBT training

EXPERIMENTAL

CBT of irony comprehension

Behavioral: CBT of irony comprehension

No Intervention

NO INTERVENTION

No Intervention

Interventions

CBT of irony comprehensionBEHAVIORAL

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.

Irony CBT training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • People suffering from any disabilities or handicap which limits their judgment
  • With a guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brull- Tel Aviv Community Mental Health Center

Tel Aviv, Select Your State, 43562, Israel

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Dror Dolfin, MD

    Clalit Health Services

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Dolfin

CONTACT

972505406993zdolfin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 9, 2014

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

IL(1)