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: Unknown

94 Participants Needed

Trial Summary

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.

Eligibility Criteria

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.

Treatment Details

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.

Participant Groups

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+