Clinical trial NCT02038465: Cognitive Remediation of Autobiographical Memory in Schizophrenia Using SenseCam®
Official title: REMEDIATION COGNITIVE DE LA MÉMOIRE AUTOBIOGRAPHIQUE DANS LA SCHIZOPHRENIE AU MOYEN DE SENSECAM
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia Cognition Autobiographical Memory Cognitive Remediation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Specificity of memories recovered by using the SenseCam camera during the trial
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Berna
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Fabrice Berna, MD
role: PRINCIPAL_INVESTIGATOR
References: