Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder

NCT ID: NCT06007612

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2023-11-30

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.

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.

Conditions

Complex Post-Traumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Behavioral: Context Sensitivity in Emotion Regulation

Group Type: EXPERIMENTAL

Context Sensitivity in Emotion Regulation

Intervention Type: BEHAVIORAL

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

Interventions

Context Sensitivity in Emotion Regulation

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gal Sheppes

OTHER

Sponsor Role: lead

Responsible Party

Gal Sheppes

Principal Investigator of Emotion Regulation Lab

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tel Aviv University

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Gal Sheppes, PhD

Role: primary

gsheppes@gmail.com

972-3-6408977

Naomi B Fine, PhD

Role: backup

naomifine@mail.tau.ac.il

0528681031

Other Identifiers

Sheppes02

Identifier Type: -

Identifier Source: org_study_id