94 Participants Needed

RTM vs PE for PTSD

(RECONTROLPTSD Trial)

PB
MR
Overseen ByMichael Roy, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Uniformed Services University of the Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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, with and without TBI, must be developed and evaluated. RTM is safe and promising, but requires testing against evidence-based interventions in well-designed randomized clinical trials (RCTs). The full study can be conducted either in person or via secure video conferencing.

Are You a Good Fit for This Trial?

This trial is for active or retired service members with PTSD who experience nightmares or flashbacks. Participants must understand the consent process and be open to random treatment assignment. Those with a history of psychosis, bipolar disorder, or current suicidal/homicidal thoughts cannot join.

Inclusion Criteria

I understand the consent process after answering some questions.
I have PTSD with recent nightmares or flashbacks.
Willing to be randomly assigned to one of the two interventions and to complete all study measures.
See 1 more

Exclusion Criteria

You have a history of serious mental health issues like seeing or hearing things that aren't real.
You are currently thinking about hurting yourself or someone else.
You have been diagnosed with bipolar disorder in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive up to 10 sessions of either RTM or PE therapy, typically administered once per week for 10 weeks

10 weeks
10 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 2, 6, and 12 months

12 months
4 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Prolonged Exposure (PE)
  • Reconsolidation of Traumatic Memories (RTM)
Trial Overview The study compares Reconsolidation of Traumatic Memories (RTM), a new therapy that modifies traumatic memories to reduce their impact, against Prolonged Exposure (PE), an established PTSD treatment. The goal is to see if RTM can match PE's effectiveness while possibly offering faster relief.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Reconsolidation of Traumatic Memories (RTM)Experimental Treatment1 Intervention
Group II: Prolonged Exposure (PE)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Uniformed Services University of the Health Sciences

Lead Sponsor

Trials
130
Recruited
91,100+

Research and Recognition Project

Collaborator

Trials
1
Recruited
90+
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