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RTM vs PE for PTSD (RECONTROLPTSD Trial)
Phase 2 & 3
Recruiting
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
RECONTROLPTSD Trial 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.Check my eligibility
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.See study design
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.
RECONTROLPTSD Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have PTSD with recent nightmares or flashbacks.
Select...
I understand the consent process after answering some questions.
RECONTROLPTSD Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinician Administered PTSD Symptom Scale for DSM5 (CAPS-5)
Secondary outcome measures
Change in Neurobehavioral Symptom Inventory (NSI) Score
Change in PTSD Checklist for DSM5 (PCL5) Score
Change in Patient Health Questionnaire (PHQ-9) Score
+2 moreOther outcome measures
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 moreRECONTROLPTSD 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.
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Who is running the clinical trial?
Uniformed Services University of the Health SciencesLead Sponsor
116 Previous Clinical Trials
91,505 Total Patients Enrolled
Research and Recognition ProjectUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of serious mental health issues like seeing or hearing things that aren't real.I understand the consent process after answering some questions.I have PTSD with recent nightmares or flashbacks.You are currently thinking about hurting yourself or someone else.You have been diagnosed with bipolar disorder in the past.I am willing to be randomly assigned to a treatment and follow all study requirements.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Reconsolidation of Traumatic Memories (RTM)
- Group 2: Prolonged Exposure (PE)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are the most that will be used in this clinical trial?
"Yes, the trial is currently ongoing and is recruiting patients. The listing on clinicaltrials.gov says that the study was first posted on June 12th, 2019 and was last edited on August 9th, 2021. They are looking for 108 patients total, at a single location."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Michigan
How old are they?
18 - 65
What site did they apply to?
Uniformed Services University of Health Sciences (USUHS)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
i have been on Prozac, Paxil, Remeron, Welbutrin, Adderall, and effexor from early teens until now.
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Uniformed Services University of Health Sciences (USUHS): < 24 hours
Average response time
- < 1 Day
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