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

August 24, 2018 updated by: University Hospital, Strasbourg, France

REMEDIATION COGNITIVE DE LA MÉMOIRE AUTOBIOGRAPHIQUE DANS LA SCHIZOPHRENIE AU MOYEN DE SENSECAM

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patient
Complete questionary remembering the day
Device: Questionary
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for patient
Device: Questionary
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for healthy volunteers
Other: healthy volunteers
- Complete questionary, remembering the day
Device: Questionary
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for patient
Device: Questionary
Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for healthy volunteers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity of memories recovered by using the SenseCam camera during the trial
Time Frame: 1 month
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
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Fabrice Berna, MD, Les Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 24, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5539

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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