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Recruiting NCT07658157

Exposure by Assessment: Effects of Daily AMQ-Based EMA of an Intrusive Trauma Memory in PTSD

No phase Interventional PTSD

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AMQ-based ecological momentary assessment of an intrusive memory, AMQ-based ecological momentary assessment of an emotionally neutral memory.
Who it may be relevant to
Registry conditions: PTSD. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Israel
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

Intrusive re-experiencing is a defining burden for many people with PTSD, often disrupting routines and making it hard to participate in care. Intrusion symptoms tend to be resistant to change, even when broader PTSD symptoms improve (Bar-Haim et al., 2021; Levi et al., 2022). This pattern underscores the need for brief, remote approaches tuned to everyday intrusion dynamics.

The study tests a home-based intervention requiring minimal clinician input that aims to reduce intrusive symptoms. Ecological momentary assessment (EMA) offers such an opportunity. Although typically used for data collection, Pollmann et al. (2024) reported preliminary evidence suggesting that two weeks of EMA focused on a traumatic intrusive memory (TR-IM) were followed by reductions in intrusion symptoms, while other symptom clusters remained comparatively unchanged. Pollmann et al. used prompts adapted from the Autobiographical Memory Questionnaire (AMQ; Rubin et al., 2003). However, in the absence of a control condition, it remains uncertain whether the observed change reflects targeted, safe-context activation of the traumatic memory, a general cognitive-distancing effect from repeated ratings regardless of target, or a different process altogether. A further methodological limitation is that EMA completion depended on participants' spontaneous recollection of the TR-IM in the preceding hours. As a result, responses were intermittent and varied across days and individuals, leading to uneven exposure and data gaps.

The present study aims to test the mechanism in question as well as to create a different setting in which all participants answer the questionnaire at each EMA prompt. Adults with PTSD who report active intrusions will be randomized to one of two otherwise identical 10-day EMA protocols: (1) daily AMQ-based prompts that explicitly target a personally identified TR-IM, or (2) the same prompts targeting a neutral, non-intrusive memory. Primary outcomes will be baseline to post-treatment change and baseline to follow-up change on clinician-rated CAPS-5 total score and CAPS-5 Cluster B indices. Secondary outcomes will be self-reported PCL-5 total score and cluster B scores.

Interventions

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

Primary outcome measures

  • Change from Baseline in Clinician-Rated PTSD Symptom Severity as Assessed by the CAPS-5 Total Severity Score at Post-Intervention and Follow-Up [Time frame: 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 [Time frame: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.]
Secondary outcome measures (2)
  • Change from Baseline in Self-Reported PTSD Symptom Severity as Assessed by the PCL-5 Total Score at Post-Intervention and Follow-Up [Time frame: 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 [Time frame: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Israel · 1 center
  • Tel Aviv University — Tel Aviv

Publications

  • 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 28493729
  • 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 16717171
  • 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 9881538
  • 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 14651297
  • 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.
  • 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 11556941
  • 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 32975451
  • 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 30178492

Identifiers

NCT: NCT07658157 · EMA_Memories

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗