RECONsolidation of Traumatic Memories to ResOLve Post Traumatic Stress Disorder (RECONTROLPTSD)

Summary

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.

Conditions

• Posttraumatic Stress Disorder
• Traumatic Brain Injury

Interventions

BEHAVIORAL

Reconsolidation of Traumatic Memories (RTM)

RTM is a trauma-focused, but not cognitive behavioral, therapy: it involves brief exposure to the trauma memory, but does rely on conscious responses to correct the symptoms of PTSD. RTM was first used to treat phobias in the 1970s, and has more recently been refined to focus on reconsolidation to update long-term memories, reconfiguring the salience structure of the original memory, and incorporating those changes into the overall memory structure. Reconsolidation is a neural mechanism for updating long-term memory, inserting new information that contradicts an essential element of the memory, which makes it possible to change the emotional tone and salience of the memory. It is hypothesized that RTM can thereby achieve quicker, greater, and more durable responses than with "traditional" exposure therapies.

BEHAVIORAL

Prolonged Exposure (PE)

PE is a trauma-focused cognitive behavioral therapy (TFCBT) that depends on exposure to the feared stimulus as a central effector of change, utilizing extinction, which theorizes that if a trigger that previously elicited a fear response is presented enough times without reinforcement, the response fades. Previous researchers have shown that extinction involves the creation of a new blocking memory which prevents expression of the original fear memory. While PE has more evidence to support its efficacy in PTSD than other approaches, and a majority achieve a clinical response (e.g., decrease in CAPS score of 10 or more), many do not achieve complete remission of symptoms, and the blocking memory may be fragile, so subsequent triggers may result in relapse.

Sponsors & Collaborators

• Research and Recognition Project

  collaborator UNKNOWN

• Uniformed Services University of the Health Sciences

  lead FED

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-12

Primary Completion

2024-04-30

Completion

2025-05-06

Countries

• United States

Study Locations