Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial (Preprint)
Aaron Emile Philipp-Muller, Taras Reshetukha, Gustavo Vazquez, Roumen Milev, Dawn Armstrong, Jasleen Jagayat, Nazanin Alavi
Study at a glance
AI-extracted from the abstract| Characteristics | Open-label randomized controlled trial protocol |
|---|---|
| Sample size | 20 |
| Population | Patients with refractory posttraumatic stress disorder recruited from a community clinic |
| Interventions | Ketamine electronically delivered cognitive behavioral therapy (e-CBT) |
| Dose | subanesthetic intravenous ketamine (exact dose not stated) |
| Duration | 14-week intervention, with assessments before treatment, at two midway points, and at the end of the experiment |
| Topics | Esketamine Ketamine PTSD |
| Registration | NCT04771767 |
| Key findings | The protocol proposes testing whether subanesthetic intravenous ketamine combined with therapist-administered internet-based cognitive behavioral therapy reduces PTSD symptoms more than a waitlist control condition in patients with refractory PTSD. The authors expect a significantly greater improvement in the experimental group with a large effect size (η2=0.14). No outcome data are reported; this is a registered protocol. |
Abstract
Background: Over one third of patients with posttraumatic stress disorder (PTSD) do not respond to current interventions. Ketamine presents a potential treatment option; however, its effects are temporary. Administering ketamine alongside psychotherapy is one potential means of prolonging its effects; however, only a few studies have investigated this treatment method to date, and none have tested ketamine with internet-based or electronically delivered cognitive behavioral therapy (e-CBT).
Objective: This open-label randomized controlled trial aims to assess the efficacy of a combined treatment method of subanesthetic intravenous ketamine and e-CBT for treating patients with PTSD.
Methods: In total, 20 patients with refractory PTSD recruited from a community clinic will be randomly assigned to either an experimental group (n=10), receiving a combination of ketamine and therapist-administered e-CBT over 14 weeks, or a waitlist control group (n=10), receiving the experimental treatment after 14 weeks. Both groups will be assessed for the symptoms of PTSD and comorbid disorders before treatment, at two midway points, and at the end of the experiment.
Results: PTSD symptoms of participants in the experimental group are expected to improve significantly more than those of participants in the waitlist control group (P=.05) with a large effect size (η2=0.14).
Conclusions: This is the first study to assess the relationship between e-CBT and ketamine and their combined ability to treat refractory PTSD. If successful, this study will open web-based, asynchronous therapeutic options for patients with PTSD and will provide new insights into the functional role of glutamate in trauma-related disorders as well as in learning, memory, and fear extinction. CLINICALTRIAL ClinicalTrials.gov NCT04771767; https://clinicaltrials.gov/ct2/show/NCT04771767. INTERNATIONAL REGISTERED REPORT PRR1-10.2196/30334
Comparable studies
Other randomized controlled trials on ketamine for PTSD, most cited first.
Citations in the library
Cites 5
- A Randomized Trial of an N-methyl-D-aspartate Antagonist in Treatment-Resistant Major Depression Archives of General Psychiatry August 1, 2006
- Antidepressant Efficacy of Ketamine in Treatment-Resistant Major Depression: A Two-Site Randomized Controlled Trial American Journal of Psychiatry August 28, 2013
- Efficacy of Intravenous Ketamine for Treatment of Chronic Posttraumatic Stress Disorder JAMA Psychiatry April 16, 2014
- A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders JAMA Psychiatry March 1, 2017
- d-Serine is a potential biomarker for clinical response in treatment of post-traumatic stress disorder using (R,S)-ketamine infusion and TIMBER psychotherapy: A pilot study. Biochimica et Biophysica Acta. Proteins and Proteomics March 18, 2018