Emotion Regulation Selection Flexibility Training for PTSD Patients

NCT06943560 | Recruiting

• 1 other identifier: Sheppes01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will examine the efficacy of a novel intervention aimed at improving Regulatory Selection Flexibility and PTSD symptoms among adult individuals with PTSD symptoms, compared to a tight active control group.

Conditions

PTSD

Keywords

EMOTION REGULATION

Outcome Measures

Primary Outcomes (2)

• Pre to Post improvement of emotion regulatory selection flexibility

  regulatory selection flexibility is calculated by subtracting adaptive choice from the maladaptive choice specifically by subtracting the proportion of distraction selection in the low intensity stimuli (maladaptive choice) from the proportion of distraction selection in the high intensity stimuli (adaptive choice).

  Measurements at Baseline and immidiately post treatment

• Change from baseline of the total score of the PTSD Checklist (PCL-5)

  The PCL-5, is a 20-item PTSD Checklist for DSM-5. Scores can range from 0 to 80, with higher scores reflecting more PTSD symptoms.

  Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment

Other Outcomes (3)

• Change from baseline of the total score of the Sheehan Disabilities Scale (SDS)

  Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment

• Change from baseline of the total score of the Beck Depression Inventory (BDI)

  Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment

• Change from baseline of the total score of the Perceived Ability to Cope With Trauma (PACT) Scale

  Measurements at Baseline, immediately post treatment, and 3-months follow-up post treatment

Study Arms (2)

Regulatory selection Flexibility Training

EXPERIMENTAL

Behavioral: Emotion Regulation Selection Flexibility Training

Tight Active control Training

EXPERIMENTAL

Behavioral: Emotion Regulation Active control Training

Interventions

Emotion Regulation Selection Flexibility Training BEHAVIORAL

7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between intervention session to be completed on days without sessions. Psychoeducation includes information on selection of appropriate strategy according to the regulatory selection flexibility rule (i.e., distraction for high intensity vs reappraisal in low intensity). In the computerized task participants are exposed to emotional words and are asked to select a regulatory strategy in a flexible matter according to the regulatory selection flexibility rule, and receive feedback on whether they chose flexibly or not. Following , they are instructed to implement the chosen strategy. Homework includes choosing two daily events one of high intensity and a second one of low intensity, and describe which strategy they selected and how they implemented their chosen strategy according to the flexibility rule.

Regulatory selection Flexibility Training

Emotion Regulation Active control Training BEHAVIORAL

All the interventional sections are similar to the experimental group except that in the control group we omit the regulatory selection rule that defines which strategy is compatible with which emotional situation. 7 online computerized regulatory selection training sessions that includes a fully computerized part, and an interactive, human operated part guided by a clinician and home assignments between intervention session to be completed on the days without sessions. Psychoeducation explicitly included information on regulatory strategies (without the regulatory selection flexibility rule). In the computerized task participants are exposed to the same emotional words and are asked to choose freely a regulatory strategy (without the regulatory selection flexibility rule or feedback), and implement it. Homework includes choosing two daily events and selecting and implementing a regulatory strategy (without the regulatory selection flexibility rule).

Tight Active control Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• fulfill screening criteria of DSM-V for PTSD

You may not qualify if:

• Complex PTSD
• Psychotic disorders
• substance dependence or abuse other than nicotine
• Neurological condition
• suicidal ideation or attempt
• change in psychotherapy or pharmacological treatment in the past 3 months.
• Diagnosed/suspected personality Disorder
• Cognitive impairments

Sponsors & Collaborators

• Tel Aviv University: lead

Study Sites (1)

Tel Aviv University

Tel Aviv, 6997801, Israel

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Emotional Regulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Gal Sheppes, PhD

CONTACT

0528681031; gsheppes@gmail.com

Naomi Fine, PhD

CONTACT

0528681031; naomifine@mail.tau.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Emotion Regulation Lab

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: April 24, 2025
• Study Start: October 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: April 1, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

IL (1)