At a glance
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Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
In Brief
A Phase 2 clinical trial evaluating Psychotherapy plus Methylene Blue, USP, Psychotherapy plus Placebo, and 1 other intervention for Chronic Posttraumatic Stress Disorder. Completed, enrolled 42 participants across 3 sites.
Detailed Summary
Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a traumatic event and intense, persistent feelings of anxiety. There are several effective therapies for PTSD, but they are often time consuming. The investigators want to see if the investigators can shorten treatment time while keeping therapy effective by adding a medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To examine whether medication plus psychotherapy helps with depression, trauma-related cognitions, and functioning.
Study Details
Timeline
Interventions
This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).