Cognitive Remediation of Autobiographical Memory in Schizophrenia Using SenseCam®

NCT ID: NCT02038465

Last Updated: 2018-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-12-31

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.

Conditions

Schizophrenia Cognition Autobiographical Memory Cognitive Remediation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

patient

Complete questionary remembering the day

Group Type: OTHER

Questionary

Intervention Type: DEVICE

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

Questionary

Intervention Type: DEVICE

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

healthy volunteers

\- Complete questionary, remembering the day

Group Type: OTHER

Questionary

Intervention Type: DEVICE

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

Questionary

Intervention Type: DEVICE

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

Interventions

Questionary

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

Intervention Type: DEVICE

Questionary

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fabrice Berna, MD

Role: PRINCIPAL_INVESTIGATOR

Les Hôpitaux Universitaires de Strasbourg

Locations

Berna

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Fabrice Berna, MD

Role: CONTACT

fabrice.berna@chru-strasbourg.fr

Facility Contacts

Fabrice Berna, MD

Role: primary

fabrice.berna@chru-strasbourg.fr

Other Identifiers

5539

Identifier Type: -

Identifier Source: org_study_id