Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD

This interventional pilot study (n=16) was conducted by the Icahn School of Medicine at Mount Sinai. The study aimed to evaluate the efficacy of adding Written Exposure Therapy (WET) to repeated intravenous ketamine infusions in improving PTSD symptoms and maintaining symptom improvement in patients with chronic PTSD.

Participants aged 18 to 70 years who met DSM-5 criteria for chronic PTSD were enrolled. They received a total of six ketamine infusions and participated in WET consisting of five sessions. WET sessions were interleaved with the last two ketamine infusions to take advantage of increased neuroplasticity potentially. The primary outcome measure was the change in PTSD symptom severity from baseline to 12 weeks from the start of WET, assessed using the Clinician-Administered PTSD Scale for DSM-5. The study also evaluated whether extinction learning ability predicted maintenance of ketamine response over time and explored potential predictors of treatment response.

The study, which started on June 4, 2021, and was completed on October 14, 2023, involved 16 participants. It was designed as an open-label pilot study with a single-group assignment. The study location was Manhattan, New York, United States.

Trial Details

The current pilot project will evaluate the efficacy of adding Written Exposure Therapy (WET) to a course of repeated IV ketamine infusions in improving PTSD symptoms and maintaining symptom improvement in patients with chronic PTSD. WET is a brief, 5-session evidence-based written trauma-focused therapy without in between-session assignments, with demonstrated efficacy and low dropout rates in patients with PTSD. WET will be administered to all eligible participants; the first WET sessions will be interleaved with the last two ketamine infusions to take advantage of a window of increased neuroplasticity potentially induced by repeated ketamine infusions. WET will be administered on different days as the ketamine infusions.

NCT Number NCT04889664

Data attribution

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