Exposure by Assessment: Effects of Daily AMQ-Based EMA of an Intrusive Trauma Memory in PTSD
ConditionPTSD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTel Aviv University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18-70
Posttraumatic stress disorder
intrusive symptoms.
Disqualifiers
Psychotic or bipolar disorder
Heavy use of drugs or alcohol
Prominent personality disorder
Significant risk of harm to self or others
Trial design
Design model
Parallel
Treatments tested in this trial
AMQ-based ecological momentary assessment of an intrusive memory
Other interventionParticipants 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.
AMQ-based ecological momentary assessment of an emotionally neutral memory
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Neutral MemorySham comparator 1 intervention
Group B: Intrusive MemoriesActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.2
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.
Time frame
From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.Secondary outcomes
1
Change from Baseline in Self-Reported PTSD Symptom Severity as Assessed by the PCL-5 Total Score at Post-Intervention and Follow-Up
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.2
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
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.
Time frame
From baseline to post-intervention - 10 days; Follow-up data will be collected 15-30 days following the post-intervention assessment.Sponsors and contacts
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Source ClinicalTrials.gov