Psychotherapy plus Methylene Blue, USP
DrugThis 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.
NCT Number: NCT01188694
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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 2
University of Pennsylvania, Philadelphia, Pennsylvania, United States
The psychotherapy the investigators are offering in this study is a type of cognitive behavioral therapy called imaginal exposure. In imaginal exposure, the investigators encourage the client to approach the memory of the trauma by recounting the trauma story to the therapist and discussing his or her reactions to the memory.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Time frame: Pre-treatment, post-treatment (4 weeks from pre-), 1-month follow-up (from post-), and 3-month follow-ups (from post-)
PTSD Symptom Scale - Interview Version, higher scores represent higher PTSD severity (range 0 - 51)
University of Washington
Other
Acronym: HELP
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