← Back to Search

RTM vs PE for PTSD (RECONTROLPTSD Trial)

Phase 2 & 3

Waitlist Available

Research Sponsored by Uniformed Services University of the Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets criteria for PTSD on the CAPS5, with past month nightmares or flashbacks.

Able to exhibit capacity to understand the informed consent process, by completion of a corresponding series of questions

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 10, and 2, 6 and 12 months later, compared to baseline

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a novel treatment for PTSD called reconsolidation of memories (RTM) versus the current best treatment, prolonged exposure (PE). The goal is to see if RTM is better at reducing symptoms, improving cognitive function, and achieving remission.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed for RTM and PE therapies in this summary, psychological interventions may sometimes cause temporary increases in distress due to confronting traumatic memories.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have PTSD with recent nightmares or flashbacks.

Select...

I understand the consent process after answering some questions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 10, and 2, 6 and 12 months later, compared to baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 10, and 2, 6 and 12 months later, compared to baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 10, and 2, 6 and 12 months later, compared to baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)

Secondary study objectives

Change in Neurobehavioral Symptom Inventory (NSI) Score

Change in PTSD Checklist for DSM5 (PCL5) Score

Change in Patient Health Questionnaire (PHQ-9) Score

+2 more

Other study objectives

Change in NIH Toolbox Cognition Battery (NIH-TB) Neurocognitive Assessment Composite Score

Change in plasma interleukin-10 level

Change in plasma interleukin-6 level

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Reconsolidation of Traumatic Memories (RTM)Experimental Treatment1 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 Control1 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.

0 / 2Eligibility criteria met