NCT06007612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

August 17, 2023

Last Update Submit

August 24, 2023

Conditions

Keywords

EMOTION REGULATION

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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)

Study Arms (1)

Behavioral: Context Sensitivity in Emotion Regulation

EXPERIMENTAL
Behavioral: Context Sensitivity in Emotion Regulation

Interventions

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

Behavioral: Context Sensitivity in Emotion Regulation

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Psychosis
  • substance dependence or abuse other than nicotine
  • Neurological condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 2 groups enrolled in a one-time behavioral paradigm
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator of Emotion Regulation Lab

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 23, 2023

Study Start

April 13, 2023

Primary Completion

November 30, 2023

Study Completion

November 30, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations