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NCT03827057 · ClinicalTrials.gov registry record · Phase 2
RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)
A Phase 2 study, sponsored by Uniformed Services University of the Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT03827057 is a Phase 2 study that has completed, run by Uniformed Services University of the Health Sciences. The registered enrollment target is 94 participants.
The verdict
NCT03827057, a Phase 2 study, has completed, sponsored by Uniformed Services University of the Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspective) to make it less impactful, and reduce nightmares, flashbacks, and other features of PTSD. The memory is reviewed in the context of an imaginal movie theater, presenting a fast (\~45 sec) black and white movie of the trauma memory, with further adjustment as needed so the patient can comfortably watch it. Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial comparing RTM versus prolonged exposure (PE), the PTSD therapy with the strongest current evidence base. The investigators hypothesize that RTM will be non-inferior to PE in reducing PTSD symptom severity post-treatment and at 1-year follow up; will achieve faster remission, with fewer dropouts; will improve cognitive function; and that epigenetic markers will correlate with treatment response. The investigators will randomize 108 active or retired service members (SMs) with PTSD to ≤10 sessions of RTM or PE, affording power to test our hypotheses while allowing for ≤ 25% dropouts. The investigators will use an intent to treat analysis, and the Clinician Administered PTSD Scale for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, or DSM5 (CAPS-5), conducted by blinded assessors, will be the primary outcome measure. Secondary measures of depression (PHQ-9), anxiety (GAD-7), sleep (PSQI), and functional status (WHOQOL-100), will be assessed pre- and post-treatment, and at 2, 6, and 12 months. ANOVA will compare symptom severity over time within and between groups. The investigators will track comorbid TBI, anticipating it will not adversely impact response. More effective therapies for PTSD,
Interventions
- BEHAVIORAL Prolonged Exposure (PE)
- BEHAVIORAL Reconsolidation of Traumatic Memories (RTM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2019-06-12 |
| Est. Completion | 2025-05-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03827057
The ClinicalTrials.gov registry entry for NCT03827057 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Uniformed Services University of the Health Sciences, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Prolonged Exposure (PE) is the first listed.
NCT03827057 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03827057 about?
NCT03827057 is a clinical study titled "RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)". Posttraumatic Stress Disorder (PTSD) is a common cause of morbidity in combat veterans, but current treatments are often inadequate. Reconsolidation of Traumatic Memories (RTM) is a novel treatment that seeks to alter key aspects of the target memory (e.g., color, clarity, speed, distance, perspecti...
What is the current status of trial NCT03827057?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2019-06-12. Estimated completion is 2025-05-06.
What interventions are being tested in trial NCT03827057?
The interventions under investigation include: Prolonged Exposure (PE) (BEHAVIORAL), Reconsolidation of Traumatic Memories (RTM) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03827057?
This trial is sponsored by Uniformed Services University of the Health Sciences, which has 27 total clinical trials registered on ClinicalTrials.gov.
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