NCT02038465

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.

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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

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

June 25, 2013

Completed
7 months until next milestone

First Posted

Study publicly available on registry

January 16, 2014

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

5.3 years

First QC Date

June 25, 2013

Last Update Submit

August 24, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    1 month

Study Arms (2)

patient

OTHER

Complete questionary remembering the day

Device: Questionary

healthy volunteers

OTHER

\- Complete questionary, remembering the day

Device: Questionary

Interventions

Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for patient

healthy volunteerspatient

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berna

Strasbourg, 67000, France

RECRUITING

Study Officials

  • Fabrice Berna, MD

    Les Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice Berna, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 25, 2013

First Posted

January 16, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations