Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder

Complex Post-Traumatic Stress Disorder Clinical Trial

Official title:

Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007612
• Other study ID #: Sheppes02
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Complex Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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

Locations

Country	Name	City	State
Israel	Tel Aviv University	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Gal Sheppes

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in accurate intensity classification measured during Block A of the experiment	comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.	During the experimental task (1 hour)
Primary	regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm	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.	During the experimental task (1 hour)
Primary	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	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	During the experimental task (1 hour)