NCT03040505

Brief Summary

The aim of the study is to investigate temporal organization of future thinking in patients with schizophrenia. Patients and control participants will be asked to envision and briefly describe ten personal future events using a cue-words list. Then they will be asked to describe everything that came to their minds (i.e. to think aloud) while they attempted to determine when an event will likely occur. The investigators will compare the proportion of several predefined strategies mentioned by the two groups of participants to locate future events in time. The investigators predict that patients will envision less personal future events and will rely to a lesser extent on strategies to locate events in time, than control participants.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

January 27, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 2, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

April 5, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2019

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

2.5 years

First QC Date

January 27, 2017

Last Update Submit

August 21, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of time location strategies

    1 months

Study Arms (2)

Patients with schizophrenia

Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria

Other: questionnary

Control participants

\- Control participants without psychiatric nor neurological history

Other: questionnary

Interventions

Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.

Control participantsPatients with schizophrenia

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

patients with Schizophrenia

You may qualify if:

  • for patients only
  • male or female
  • age limits : 18-55 years old
  • under the protection of health insurance
  • who have signed up the consent form
  • schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA, 2013).
  • clinically stable for at least 2 months
  • patients under guardianship or curatorship need agreement of their legal representative
  • informed of the results of prior medical examination for controls only
  • male or female
  • age limits : 18-55 years old
  • under the protection of health insurance
  • who have sign up the consent form
  • recruited from the general population and matched on gender, age years of schooling
  • no psychiatric history (DSM-5)

You may not qualify if:

  • for both patients and controls
  • current severe or unstable somatic illness
  • neurological history (brain injury \> 15 minutes loss of consciousness , epilepsia, brain surgery…)
  • current substance use disorder (DSM-5)
  • current major depressive disorder (CDSS,BDI, HDRS)
  • mental retardation (IQ \< 70, WAIS-4, f-NART)
  • history of general anesthesia 3 months prior to the experiment
  • pregnancy declared by the subject
  • breast feeding
  • current legal control
  • in emergency situation
  • for controls only
  • under guardianship or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie 1

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 2, 2017

Study Start

April 5, 2017

Primary Completion

October 20, 2019

Study Completion

October 20, 2019

Last Updated

August 23, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations