- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07658157
Exposure by Assessment: Effects of Daily AMQ-Based EMA of an Intrusive Trauma Memory in PTSD
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
We test a home-based intervention requiring minimal clinician input that aims to reduce intrusive symptoms. Ecological momentary assessment (EMA) offers such 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. Their prompts were adapted from the Autobiographical Memory Questionnaire (AMQ; Rubin et al., 2003). However, in the absence of a control arm, 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 tests the mechanism in question as well as creating a different setting in which all participants answer the questionnaire every time. Adults with PTSD who report active intrusions will be randomized to one of two otherwise identical 10-days 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 .
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Yuval Heimann, MA Student
- Numer telefonu: +972545698181
- E-mail: yuvalheimann@mail.tau.ac.il
Kopia zapasowa kontaktu do badania
- Nazwa: Yair Bar-Haim, PhD
- Numer telefonu: 972-52-7346610
- E-mail: yair1@tauex.tau.ac.il
Lokalizacje studiów
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Tel Aviv, Izrael
- Rekrutacyjny
- Tel Aviv University
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Kontakt:
- Lital Kohn, MA
- Numer telefonu: +972556635268
- E-mail: litalkohn@tauex.tau.ac.il
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults aged 18-70 with symptoms of posttraumatic stress disorder and intrusive symptoms.
Exclusion Criteria:
- Psychotic disorder or bipolar disorder; heavy use of drugs or alcohol; prominent personality disorders; significant risk of harm to self or others; current trauma-focused treatment; reporting intrusions as thoughts only rather than as memories.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Potroić
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Pozorny komparator: Neutral Memory
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.
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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.
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Aktywny komparator: Intrusive Memories
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.
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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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Clinician-Rated PTSD Symptom Severity as Assessed by the CAPS-5 Total Severity Score at Post-Intervention and Follow-Up
Ramy czasowe: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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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.
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From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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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
Ramy czasowe: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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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.
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From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change from Baseline in Self-Reported PTSD Symptom Severity as Assessed by the PCL-5 Total Score at Post-Intervention and Follow-Up
Ramy czasowe: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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Self-reported PTSD symptom severity will be assessed using the PTSD Checklist for DSM-5 (PCL-5) total score.
The PCL-5 is a self-report measure assessing PTSD symptoms over the past specified time period.
Change from baseline will be evaluated at post-intervention and follow-up.
Higher PCL-5 total scores indicate greater PTSD symptom severity.
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From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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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
Ramy czasowe: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
|
Self-reported PTSD intrusion symptom severity will be assessed using the Cluster B score of the PTSD Checklist for DSM-5 (PCL-5).
Cluster B reflects intrusion symptoms, including intrusive memories, distressing dreams, dissociative reactions/flashbacks, emotional distress at reminders, and physical reactions at reminders.
Change from baseline will be evaluated at post-intervention and follow-up.
Higher PCL-5 Cluster B scores indicate greater self-reported intrusion symptom severity.
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From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Yair Bar Haim, Professor, Tel Aviv University
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Rubin DC, Schrauf RW, Greenberg DL. Belief and recollection of autobiographical memories. Mem Cognit. 2003 Sep;31(6):887-901. doi: 10.3758/bf03196443.
- 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.
- 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.
- 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.
- 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.
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EMA_Memories
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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