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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02038465
Other study ID # 5539
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date December 2019

Study information

Verified date August 2018
Source University Hospital, Strasbourg, France
Contact Fabrice Berna, MD
Email fabrice.berna@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date December 2019
Est. primary completion date September 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Schizophrenia
  • Schizophrenia Cognition Autobiographical Memory Cognitive Remediation

Intervention

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

Locations

Country Name City State
France Berna Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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