Tel Aviv University
Tel Aviv, Israel
Location status: Recruiting
NCT Number: NCT07658157
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.
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Request Info18 year–70 year
All sexes
Interventional
Not applicable
Tel Aviv, Israel
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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.
Time frame: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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.
Time frame: From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.
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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Yair Bar-Haim, PhD
CONTACT
Yuval Heimann, MA Student
CONTACT
Tel Aviv University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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