RTM vs PE for PTSD

(RECONTROLPTSD Trial)

Overseen By Michael Roy, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Uniformed Services University of the Health Sciences

Disqualifiers: Psychosis, Bipolar, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 15

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better treatments for Posttraumatic Stress Disorder (PTSD) in military veterans. It compares two therapies: Reconsolidation of Traumatic Memories (RTM), which alters the experience of a traumatic memory, and Prolonged Exposure (PE), a well-established therapy. The goal is to determine if RTM can be as effective as PE in reducing PTSD symptoms like nightmares and flashbacks. Veterans with PTSD who experience these symptoms and are open to trying new treatments might be suitable for this trial. Participants will be randomly assigned to one of the therapies and attend up to 10 sessions, either in person or online. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Reconsolidation of Traumatic Memories (RTM) is generally easy for patients to handle. Studies indicate that 87% to 100% of participants complete the treatment, with few dropping out, suggesting that most people manage the treatment well. Some patients even notice quick improvements in PTSD symptoms after just a few sessions.

Prolonged Exposure (PE) is a well-known therapy for PTSD. It has undergone extensive testing and is generally considered safe. Most patients do not experience serious side effects, although some might feel uncomfortable when discussing traumatic memories.

Both treatments have proven to be safe, making them good options for those considering joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Reconsolidation of Traumatic Memories (RTM) and Prolonged Exposure (PE) as treatments for PTSD because they offer unique approaches to healing trauma. RTM is distinctive because it seeks to alter the way traumatic memories are stored in the brain, potentially reducing their emotional impact. This contrasts with most current treatments that focus on managing symptoms rather than changing the memory itself. Meanwhile, PE is a well-established therapy that involves gradually facing trauma-related memories and situations in a controlled way to decrease fear and anxiety. Both treatments are being explored for their potential to provide faster and more sustained relief from PTSD symptoms compared to standard care options like medication or traditional talk therapy.

What evidence suggests that this trial's treatments could be effective for PTSD?

Research has shown that Reconsolidation of Traumatic Memories (RTM), one of the treatments studied in this trial, holds promise for treating PTSD. In one study with veterans, 71% of those who completed RTM no longer had PTSD. Another study found that 48% of participants were free of PTSD after RTM treatment. Additionally, some reports indicate that 95% of people scored below the minimal criteria for PTSD after RTM. These results suggest RTM could quickly reduce PTSD symptoms for many people.

Prolonged Exposure (PE) therapy, the other treatment studied in this trial, is currently one of the most proven treatments for PTSD. It involves gradually facing trauma memories in a safe environment, which helps reduce symptoms over time. This trial compares both treatments to determine the most effective option for those with PTSD. ^{2 3 4 6 7}

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.

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?

Group I: Reconsolidation of Traumatic Memories (RTM) Experimental Treatment 1 Intervention

Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. RTM will follow a manual developed by the Research and Recognition Project, who will also train and supervise the therapists. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 \<34, can decide with their therapist whether early cessation of therapy is appropriate.

Group II: Prolonged Exposure (PE) Active Control 1 Intervention

Participants in each arm of the study will receive up to 10 90-minute manualized treatment sessions. PE will follow a manual written by the Foa and colleagues, and the therapists will be trained by expert trainers from the Center for Deployment Psychology. It is anticipated that these treatments will most often be administered once per week for 10 weeks. To best meet participant needs, we will allow therapy in either arm to be "massed" in the pattern recently reported by Foa et al. for PE, with sessions separated by at least 24 hours over two weeks. This schedule has been used with both RTM and PE without hurting response rates, and may reduce drop-out rates. Participants who achieve remission of their PTSD before 10 sessions, measured by a PCL5 \<34, can decide with their therapist whether early cessation of therapy is appropriate.

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29241423/

A randomized controlled trial of 74 male veterans Sixty-five volunteers completed the treatment. Results: Of those treated, 46 (71%) lost DSM diagnosis for post-traumatic stress disorder (PTSD) by one of the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03827057

RECONsolidation of Traumatic Memories to ResOLve Post ... Open and waitlist studies of RTM have reported high response rates and rapid remission, setting the stage for this randomized, controlled, single-blind trial ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37833734/

Reconsolidation of traumatic memories protocol compared ... TFCBT group participants experienced a mean reduction of eight points. Forty-eight percent of the RTM group no longer met diagnostic criteria for PTSD compared ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468749924001030

The effectiveness of Reconsolidation of Traumatic ... This quasi-experimental pilot study aimed to assess the effectiveness of the RTM intervention for individuals with CPTSD at a wellness centre in India.

5. thertmprotocol.com thertmprotocol.com/assets/pdf/research-pdf/1-research.pdf

Reconsolidation of Traumatic Memories, The ... Pre- post- PSS-I-5 or PCL-5 results found that 80 (95%) scored below minimal diagnostic criteria for PTSD, exceeding previously reported success rates.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10571284/

Reconsolidation of traumatic memories protocol compared ... Results show high completion rates (ranging from 87 to 100%) and low participant dropout [13–15]. Furthermore, after a mean of three sessions a ...

7. scholar.usuhs.edu scholar.usuhs.edu/en/projects/reconsolidation-of-traumatic-memories-to-resolve-posttraumatic-st

RECONSOLIDATION OF TRAUMATIC MEMORIES TO ... Recent waitlist RCTs of RTM report remission of PTSD in ≥ 65% of completers, with symptom reductions ~40 points (PSS-I and PCL-M). The stage is now set for a ...