Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder
Primary Purpose
Complex Post-Traumatic Stress Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Context Sensitivity in Emotion Regulation
Sponsored by
About this trial
This is an interventional basic science trial for Complex Post-Traumatic Stress Disorder focused on measuring EMOTION REGULATION
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
Sites / Locations
- Tel Aviv UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioral: Context Sensitivity in Emotion Regulation
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06007612
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gal Sheppes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Post-Traumatic Stress Disorder
Keywords
EMOTION REGULATION
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
2 groups enrolled in a one-time behavioral paradigm
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral: Context Sensitivity in Emotion Regulation
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Context Sensitivity in Emotion Regulation
Intervention Description
Context Sensitivity of affective intensities and its association to Emotion Regulation Flexibility Selection
Primary Outcome Measure Information:
Title
Difference in accurate intensity classification measured during Block A of the experiment
Description
comparing the accuracy in intensity classification of 80 words stimuli between the PTSD group and the control group.
Time Frame
During the experimental task (1 hour)
Title
regulatory selection flexibility (distraction choice in high intensity minus distraction choice in low intensity) as assessed by regulatory selection paradigm
Description
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.
Time Frame
During the experimental task (1 hour)
Title
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
Description
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
Time Frame
During the experimental task (1 hour)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Tel Aviv University
City
Tel Aviv
ZIP/Postal Code
6997801
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gal Sheppes, PhD
Phone
972-3-6408977
Email
gsheppes@gmail.com
First Name & Middle Initial & Last Name & Degree
Naomi B Fine, PhD
Phone
0528681031
Email
naomifine@mail.tau.ac.il
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Context Sensitivity in Emotion Regulation in Post-Traumatic Stress Disorder
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