Clinical trial NCT06007612: Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder
Official title: Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Complex Post-Traumatic Stress Disorder
Keywords: EMOTION REGULATION
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 2 groups enrolled in a one-time behavioral paradigm
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Difference in accurate intensity classification measured during Block A of the experiment
timeFrame: During the experimental task (1 hour)
measure: regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm
timeFrame: During the experimental task (1 hour)
measure: 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
timeFrame: During the experimental task (1 hour)
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv University
Study officials:
References: