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Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects (I-TSPT-R)

Primary Purpose

Post-Traumatic Stress Disorder in Old Age

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Post Traumatic Stress Disorder
Sponsored by
Centre Hospitalier de Niort
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post-Traumatic Stress Disorder in Old Age

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

-

Regarding the constitution of the group patient (TSPT-R):

  • Subjects 65 years of age or older
  • Clinical diagnosis of delayed-onset PTSD according to DSM-5 criteria after 65 years
  • The traumatic event must have taken place at the latest before 65 years
  • Affiliated person or beneficiary of a social security scheme.
  • Written consent before any examination required by research)

Regarding the constitution of the control group:

  • Subjects 65 years of age or older
  • No diagnosis of PTSD (delayed or not) or history of PTSD (delayed or not)
  • Affiliated person or beneficiary of a social security scheme.
  • Written consent before any examination required by the research).

Exclusion Criteria:

  • For both groups:
  • Acute or chronic cognitive impairment known

  • GRECO MMSE pathological score less than or equal to the pathological threshold weighted according to level of education and age, namely:

    • 22 if no diploma
    • 23 if certificate of study
    • 25 if patent
    • 26 if bin or more
    • Remove one point at each threshold if age> 80 years
  • Sensory or motor disorder preventing the passing of different tests
  • Psychotic disorder
  • Mood disorder in decompensation (for depression, HAD-D score equal to or greater than 11)
  • Disorder of the use of a moderate or severe substance (except tobacco).
  • Patients under guardianship or curatorship.

Sites / Locations

  • Centre Hospitalier de Niort

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Patient (TSPT-R)

control

Arm Description

Post Traumatic Stress Disorder

No Post Traumatic Stress Disorder

Outcomes

Primary Outcome Measures

Inhibition score measured by the Think / No-Think Test
the average of the inhibition score measured by the "Think / No-Think" test as defined by Anderson and Green (2001) and then reviewed by Anderson et al. in 2011

Secondary Outcome Measures

Full Information

First Posted
March 29, 2019
Last Updated
July 29, 2021
Sponsor
Centre Hospitalier de Niort
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1. Study Identification

Unique Protocol Identification Number
NCT03897855
Brief Title
Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects
Acronym
I-TSPT-R
Official Title
Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
March 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Niort

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the elderly, we can see a post-traumatic syndrome associated with an event that occurred before old age that had not previously manifested or not fully manifested. This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can take in elderly subjects different masks that interfere with diagnosis and treatment. The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition, and more particularly a deficit of mental memory inhibition and therefore the removal of unwanted memories.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder in Old Age

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient (TSPT-R)
Arm Type
Other
Arm Description
Post Traumatic Stress Disorder
Arm Title
control
Arm Type
Experimental
Arm Description
No Post Traumatic Stress Disorder
Intervention Type
Other
Intervention Name(s)
Post Traumatic Stress Disorder
Intervention Description
The test "Think / No-Think"
Primary Outcome Measure Information:
Title
Inhibition score measured by the Think / No-Think Test
Description
the average of the inhibition score measured by the "Think / No-Think" test as defined by Anderson and Green (2001) and then reviewed by Anderson et al. in 2011
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: - Regarding the constitution of the group patient (TSPT-R): Subjects 65 years of age or older Clinical diagnosis of delayed-onset PTSD according to DSM-5 criteria after 65 years The traumatic event must have taken place at the latest before 65 years Affiliated person or beneficiary of a social security scheme. Written consent before any examination required by research) Regarding the constitution of the control group: Subjects 65 years of age or older No diagnosis of PTSD (delayed or not) or history of PTSD (delayed or not) Affiliated person or beneficiary of a social security scheme. Written consent before any examination required by the research). Exclusion Criteria: For both groups: Acute or chronic cognitive impairment known GRECO MMSE pathological score less than or equal to the pathological threshold weighted according to level of education and age, namely: 22 if no diploma 23 if certificate of study 25 if patent 26 if bin or more Remove one point at each threshold if age> 80 years Sensory or motor disorder preventing the passing of different tests Psychotic disorder Mood disorder in decompensation (for depression, HAD-D score equal to or greater than 11) Disorder of the use of a moderate or severe substance (except tobacco). Patients under guardianship or curatorship.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique LEGER, Doctor
Organizational Affiliation
Centre Hospitalier de Niort
Official's Role
Study Director
Facility Information:
Facility Name
Centre Hospitalier de Niort
City
Niort
ZIP/Postal Code
79021
Country
France

12. IPD Sharing Statement

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Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects

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