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Cognitive Remediation of Autobiographical Memory in Schizophrenia Using SenseCam® (RéMABSchiz)

Primary Purpose

Schizophrenia Cognition Autobiographical Memory Cognitive Remediation

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionary
Questionary
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia Cognition Autobiographical Memory Cognitive Remediation

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • for both patients and controls
  • male or female willing to participate and who have signed up the legal document
  • under the protection of health insurancefor patients only
  • schizophrenia or schizo-affective disorder according to the DSM-IV
  • TR criteria
  • clinically stable for at least 2 monthsfor controls only
  • no psychiatric history

Exclusion Criteria:

  • for both patients and controls
  • current severe or unstable somatic illness
  • neurological history (epilepsia, brain injury, brain surgery…)
  • current substance use disorder (DSM-IV-TR)
  • current major depressive disorder (DSM-IV-TR)
  • mental retardation (IQ < 70)
  • pregnancy, breast feeding
  • current legal controlfor patients only
  • treatment comprising benzodiazepines
  • benzodiazepines intake during the last 3 weeksfor controls only
  • psychotropic intake during the last 3 weeks

Sites / Locations

  • BernaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

patient

healthy volunteers

Arm Description

Complete questionary remembering the day

- Complete questionary, remembering the day

Outcomes

Primary Outcome Measures

Specificity of memories recovered by using the SenseCam camera during the trial
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam.This specificity will be evaluated by the experimenter by scoring wealth in detail memories reported during the cued recall task

Secondary Outcome Measures

Full Information

First Posted
June 25, 2013
Last Updated
August 24, 2018
Sponsor
University Hospital, Strasbourg, France
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1. Study Identification

Unique Protocol Identification Number
NCT02038465
Brief Title
Cognitive Remediation of Autobiographical Memory in Schizophrenia Using SenseCam®
Acronym
RéMABSchiz
Official Title
REMEDIATION COGNITIVE DE LA MÉMOIRE AUTOBIOGRAPHIQUE DANS LA SCHIZOPHRENIE AU MOYEN DE SENSECAM
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to assess the efficiency of SenseCam® in patients with schizophrenia by comparing two cognitive remediation methods of autobiographical memory.Patients and control participants will be invited to carry SenseCam® during 7 hours per day minimum and for 4 successive days. Each ending day when carry SenseCam®, they will be asked to go to the laboratory where 4 types of interventions will be successively done according to the randomization: 1) a simple visual retrospective procedure (SVR), 2) a visual retrospective procedure coupled with a specific cueing intervention (VR-SC), 3) a verbal retrospective (VbR) and 4) no intervention (control condition).The testing phase will take place 14 days after the last day of data collection and will consist in a cued recall task and a recognition task using the pictures obtained by the SenseCam® of the participants.According to our hypotheses, the vividness of memories will be higher in events subjected to the VR-SC procedure than in events subjected to the SVR and VbR procedures. This effect is expected for both patients with schizophrenia and controls participants. Since strategies to enrich memory details will be explicitly given to the patients when using the VR-SC procedure, we assume that patients will be able to normalize their scores.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Cognition Autobiographical Memory Cognitive Remediation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
patient
Arm Type
Other
Arm Description
Complete questionary remembering the day
Arm Title
healthy volunteers
Arm Type
Other
Arm Description
- Complete questionary, remembering the day
Intervention Type
Device
Intervention Name(s)
Questionary
Intervention Description
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for patient
Intervention Type
Device
Intervention Name(s)
Questionary
Intervention Description
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for healthy volunteers
Primary Outcome Measure Information:
Title
Specificity of memories recovered by using the SenseCam camera during the trial
Description
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam.This specificity will be evaluated by the experimenter by scoring wealth in detail memories reported during the cued recall task
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: for both patients and controls male or female willing to participate and who have signed up the legal document under the protection of health insurancefor patients only schizophrenia or schizo-affective disorder according to the DSM-IV TR criteria clinically stable for at least 2 monthsfor controls only no psychiatric history Exclusion Criteria: for both patients and controls current severe or unstable somatic illness neurological history (epilepsia, brain injury, brain surgery…) current substance use disorder (DSM-IV-TR) current major depressive disorder (DSM-IV-TR) mental retardation (IQ < 70) pregnancy, breast feeding current legal controlfor patients only treatment comprising benzodiazepines benzodiazepines intake during the last 3 weeksfor controls only psychotropic intake during the last 3 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabrice Berna, MD
Email
fabrice.berna@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrice Berna, MD
Organizational Affiliation
Les Hôpitaux Universitaires de Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Berna
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrice Berna, MD
Email
fabrice.berna@chru-strasbourg.fr

12. IPD Sharing Statement

Learn more about this trial

Cognitive Remediation of Autobiographical Memory in Schizophrenia Using SenseCam®

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