NCT07658157

Brief Summary

Intrusive re-experiencing is a hallmark of PTSD. The study applies ecological momentary assessment (EMA) of participants' trauma memories (active group) vs. EMA of a neutral memory (control group) to test whether the active intervention can reduce intrusive symptoms severity and overal PTSD symptom severity in general.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Jun 2026Jun 2027

First Submitted

Initial submission to the registry

June 14, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 14, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

June 25, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 14, 2026

Last Update Submit

June 20, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Clinician-Rated PTSD Symptom Severity as Assessed by the CAPS-5 Total Severity Score at Post-Intervention and Follow-Up

    Clinician-rated PTSD symptom severity will be assessed using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score. Change from baseline will be evaluated at post-intervention and follow-up. Higher CAPS-5 total severity scores indicate greater PTSD symptom severity.

    From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.

  • Change from Baseline in Clinician-Rated PTSD Intrusion Symptom Severity as Assessed by the CAPS-5 Cluster B Severity Score at Post-Intervention and Follow-Up

    PTSD intrusion symptom severity will be assessed using the Cluster B severity score of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). Cluster B includes clinician-rated symptoms of intrusive memories, distressing dreams, dissociative reactions/flashbacks, psychological distress at reminders, and physiological reactions to reminders. Change from baseline will be evaluated at post-intervention and follow-up. Higher CAPS-5 Cluster B scores indicate greater intrusion symptom severity.

    From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.

Secondary Outcomes (2)

  • Change from Baseline in Self-Reported PTSD Symptom Severity as Assessed by the PCL-5 Total Score at Post-Intervention and Follow-Up

    From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.

  • Change from Baseline in Self-Reported PTSD Intrusion Symptom Severity as Assessed by the PCL-5 Cluster B Score at Post-Intervention and Follow-Up

    From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.

Study Arms (2)

Neutral Memory

SHAM COMPARATOR

Participants allocated to this arm will complete AMQ-based ecological momentary assessments (EMAs) focused on an emotionally neutral memory identified at the beginning of the trial.

Other: AMQ-based ecological momentary assessment of an emotionally neutral memory

Intrusive Memories

ACTIVE COMPARATOR

Participants allocated to this arm will complete AMQ-based ecological momentary assessments (EMAs) focused on an intrusive memory identified at the beginning of the trial.

Other: AMQ-based ecological momentary assessment of an intrusive memory

Interventions

Participants allocated to this intervention will complete daily AMQ-based ecological momentary assessment (EMA) prompts for 10 days, focused on a personally identified intrusive traumatic memory. The target memory will be selected at the beginning of the trial. The EMA prompts will assess phenomenological and emotional characteristics of the memory, including features related to vividness, emotional intensity, nowness/reliving, and intrusiveness. This intervention is intended to examine whether repeated, low-burden assessment of an intrusive traumatic memory by the participant would be associated with changes in PTSD symptom severity.

Intrusive Memories

Participants allocated to this intervention will complete daily AMQ-based ecological momentary assessment (EMA) prompts for 10 days, focused on a personally identified neutral, non-intrusive autobiographical memory. The target memory will be selected at the beginning of the trial. The EMA prompts will be otherwise identical to those administered in the intrusive-memory arm and will assess phenomenological and emotional characteristics of the selected memory. This control intervention is intended to distinguish the effects of repeated memory-focused assessment in general from effects specific to repeated assessment of an intrusive traumatic memory.

Neutral Memory

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-70
  • Posttraumatic stress disorder
  • intrusive symptoms.

You may not qualify if:

  • Psychotic or bipolar disorder
  • Heavy use of drugs or alcohol
  • Prominent personality disorder
  • Significant risk of harm to self or others
  • Current trauma-focused treatment
  • Reporting intrusions as thoughts only rather than as memories

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv University

Tel Aviv, Israel

RECRUITING

Related Publications (13)

  • Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.

    PMID: 28493729BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PMID: 9881538BACKGROUND
  • Rubin DC, Schrauf RW, Greenberg DL. Belief and recollection of autobiographical memories. Mem Cognit. 2003 Sep;31(6):887-901. doi: 10.3758/bf03196443.

    PMID: 14651297BACKGROUND
  • Levi, O., Ben-Yehuda, A., Pine, D. S., & Bar-Haim, Y. (2022). A sobering look at treatment effectiveness of military-related posttraumatic stress disorder. Clinical Psychological Science. Advance online publication.

    BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND
  • Goulart AC, Bismarchi D, Rienzo M, Syllos DH, Wang YP. Dimensions of Anger Reactions (DAR-5): a useful screening tool for anger in the general population. Int J Psychiatry Clin Pract. 2021 Nov;25(4):421-429. doi: 10.1080/13651501.2020.1821893. Epub 2020 Sep 25.

    PMID: 32975451BACKGROUND
  • Cloitre M, Shevlin M, Brewin CR, Bisson JI, Roberts NP, Maercker A, Karatzias T, Hyland P. The International Trauma Questionnaire: development of a self-report measure of ICD-11 PTSD and complex PTSD. Acta Psychiatr Scand. 2018 Dec;138(6):536-546. doi: 10.1111/acps.12956. Epub 2018 Sep 3.

    PMID: 30178492BACKGROUND
  • Bovin MJ, Marx BP, Weathers FW, Gallagher MW, Rodriguez P, Schnurr PP, Keane TM. Psychometric properties of the PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (PCL-5) in veterans. Psychol Assess. 2016 Nov;28(11):1379-1391. doi: 10.1037/pas0000254. Epub 2015 Dec 14.

    PMID: 26653052BACKGROUND
  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PMID: 11438246BACKGROUND
  • Bar-Haim Y, Stein MB, Bryant RA, Bliese PD, Ben Yehuda A, Kringelbach ML, Jain S, Dan O, Lazarov A, Wald I, Levi O, Neria Y, Pine DS. Intrusive Traumatic Reexperiencing: Pathognomonic of the Psychological Response to Traumatic Stress. Am J Psychiatry. 2021 Feb 1;178(2):119-122. doi: 10.1176/appi.ajp.2020.19121231. No abstract available.

    PMID: 33517759BACKGROUND
  • Azriel O, Britton JC, Gober CD, Pine DS, Bar-Haim Y. Development and validation of the Attention Bias Questionnaire (ABQ). Int J Methods Psychiatr Res. 2022 Jun;31(2):e1905. doi: 10.1002/mpr.1905. Epub 2022 Mar 17.

    PMID: 35297127BACKGROUND
  • Pollmann Y, Clancy KJ, Devignes Q, Ren B, Kaufman ML, Rosso IM. Specific symptom change associated with ecological momentary assessments of intrusive trauma memories. NPP Digit Psychiatry Neurosci. 2024 Oct 30;2(1):18. doi: 10.1038/s44277-024-00019-4.

    PMID: 41360934BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Yair Bar Haim, Professor

    Tel Aviv University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuval Heimann, MA Student

CONTACT

Yair Bar-Haim, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 14, 2026

First Posted

June 18, 2026

Study Start

June 14, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

June 25, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations