Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder

Sponsor
Gal Sheppes (Other)
Overall Status
Recruiting
CT.gov ID
NCT06007612
Collaborator
(none)
96
1
1
7.6
12.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Context Sensitivity in Emotion Regulation
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
96 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
2 groups enrolled in a one-time behavioral paradigm2 groups enrolled in a one-time behavioral paradigm
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder
Actual Study Start Date :
Apr 13, 2023
Anticipated Primary Completion Date :
Nov 30, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Behavioral: Context Sensitivity in Emotion Regulation

Behavioral: Context Sensitivity in Emotion Regulation
Context Sensitivity of affective intensities and its association to Emotion Regulation Flexibility Selection

Outcome Measures

Primary Outcome Measures

  1. Difference in accurate intensity classification measured during Block A of the experiment [During the experimental task (1 hour)]

    comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.

  2. regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm [During the experimental task (1 hour)]

    group comparison of the association between accuracy in intensity classification (as measured in Block A) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block B.

  3. regulatory selection flexibility (measured by distraction choice in high intensity minus distraction choice in low intensity) following provided intensity as assessed by regulatory selection paradigm [During the experimental task (1 hour)]

    group comparison of the association between provided intensity classification (i.e., whether stimuli is of high or low intensity) and regulatory selection flexibility (measured by the flexibility score which is calculated by subtracting the proportion of distraction selection in the low intensity stimuli (which reflects maladaptive behavior) from the proportion of distraction selection in the high intensity pictures (which reflects adaptive behavior) measured in Block C

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Native Hebrew speakers

  • age between 18 - 65

  • normal or corrected to normal vision

  • computer and internet access

  • Group 1: Diagnosis of PTSD according to the DSM-5

  • Group 2: GAD and PHQ scores (score<10), no diagnosis of PTSD according to the DSM-5

Exclusion Criteria:
  • Psychosis

  • substance dependence or abuse other than nicotine

  • Neurological condition

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tel Aviv University Tel Aviv Israel 6997801

Sponsors and Collaborators

  • Gal Sheppes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gal Sheppes, Principal Investigator of Emotion Regulation Lab, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT06007612
Other Study ID Numbers:
  • Sheppes02
First Posted:
Aug 23, 2023
Last Update Posted:
Aug 28, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gal Sheppes, Principal Investigator of Emotion Regulation Lab, Tel Aviv University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2023