About this trial
This is a prospective randomized controlled trial comparing two ways of delivering Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) therapy for posttraumatic stress disorder (PTSD). The study seeks 60 volunteers who have PTSD and are eligible for care in the Department of Defense healthcare system. There will be 10-14 therapy sessions that are 60-90 minutes long, about once a week, and symptoms will be assessed before and after the therapy as well as 3 and 6 months after completing therapy. 3MDR asks you to choose pictures and music that are integrated into a virtual reality environment. You will be walking on a treadmill throughout each therapy session, while the therapist stands next to the treadmill and asks you questions about the pictures you chose.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Service member, veteran, retiree, or DEERS-eligible dependent, male or female, at least 18 years or older
Diagnosis of PTSD, as confirmed by the CAPS-5
Able to ambulate with contact guard assistance or less, and walk unassisted on a treadmill, at a normal pace, for up to 90 minutes continuously
Disqualifiers
History of epilepsy or a seizure disorder, other than febrile seizures that occurred during childhood and have not recurred since
History of a psychotic disorder, bipolar disorder, or active suicidal or homicidal ideation
Use of benzodiazepines on a regular basis within the previous 30 days
Trial design
Parallel
Treatments tested in this trial
Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR)
Other intervention"Walk and talk" therapy, walking on a treadmill while talking with a therapist about self-chosen pictures representative of one's trauma; 3MDR also includes some features of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR) therapy.
Treatment groups
Trial outcomes
Primary outcomes
Clinician Administered PTSD scale for DSM5 (CAPS-5)
The primary outcome measure will be the Clinician Administered PTSD scale for DSM5 (CAPS-5), the gold standard measure for PTSD diagnosis, to assess PTSD symptom severity.
PTSD Checklist for DSM5 (PCL5)
The PTSD Checklist for DSM5 (PCL5), a well-validated 20-item self-report measure of PTSD symptom severity.
Secondary outcomes
Patient Health Questionnaire Depression module (PHQ-9)
The Patient Health Questionnaire Depression module (PHQ-9) is a well-validated instrument for assessing depression symptom severity.
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a validated method with which to evaluate insomnia and sleep difficulties.
Neurobehavioral Symptom Inventory (NSI)
The Neurobehavioral Symptom Inventory (NSI) is a validated instrument for assessing postconcussive symptom severity.
Brief Resilience Scale (BRS)
The Brief Resilience Scale (BRS) is a validated instrument used to assess resilience.
Sponsors and contacts
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Uniformed Services University of the Health Sciences
Lead sponsor
Military Traumatic Brain Injury Initiative, USUHS
Collaborator
Center for Rehabilitation Sciences Research, USUHS
Collaborator