Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06007612 |
Other study ID # |
Sheppes02 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 13, 2023 |
Est. completion date |
November 30, 2023 |
Study information
Verified date |
August 2023 |
Source |
Tel Aviv University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study will examine context sensitivity, composed of two sequential elements: (a)
accurate classification of changing affective contextual demands, followed by (b) flexible
selection of regulatory strategies that matches changing contextual demands, among complex
PTSD vs. Healthy controls.
Description:
The study will recruit adults with posttraumatic stress disorder (PTSD) due to a repetitive
inter-personal trauma and healthy adult controls which do not meet DSM-5 criteria for PTSD
and do not meet the clinical cutoff of Anxiety and Depression screening questionnaires.
A compatibility check, filtering, verification of exclusion criteria and informed consent
will occur via online self-report questionnaires.
Clinical questioners include:
Life event Checklist (LEC) - PTSD criteria A Post-trauma Checklist for DSM-5 (PCL) - PTSD
symptoms Patient Health Questionnaire (PHQ-9) - Depression Symptoms General Anxiety Disorder
Questioner (GAD-7) - Anxiety Symptoms
Participants who pass the initial filtering, will be called and provided with an explanation
about the study following which they received the online experiment.
Modified regulatory selection flexibility paradigm- included 3 blocks:
(A) Stimuli Classification- 80 emotional words (equally distributed between high or low
intensities) are presented and participants are asked classify each emotional word to high or
low intensity.
(B) Regulatory Selection- 40 emotional words (out of the 80 presented in block A) are
presented and participants are instructed to behaviorally choose between distraction and
reappraisal.
(B) Regulatory Selection- 40 emotional words (the 40 remaining from block A) are presented,
prior to regulatory selection, participants received accurate normed intensity classification
of the word and then participants are instructed to behaviorally choose between distraction
and reappraisal.