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Adding Trauma-focused Psychotherapy to Ketamine Treatment for Chronic PTSD

NCT04889664 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-10-08

Study results available
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Summary

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.

Conditions

Interventions

DRUG

Ketamine

Repeated intravenous Ketamine infusions.

BEHAVIORAL

Written Exposure Therapy

WET is a brief, 5-session evidence-based written trauma-focused therapy

Sponsors & Collaborators

Principal Investigators

  • Adriana Feder, MD · Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai

  • Oneysha Brown, BA · Depression and Anxiety Center, Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-04
Primary Completion
2023-10-14
Completion
2023-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04889664 on ClinicalTrials.gov