Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial
A. Philipp-Muller, Taras Reshetukha, Gustavo Vazquez, Roumen Milev, D. Armstrong, Jasleen Jagayat, Nazanin Alavi
JMIR Research Protocols May 11, 2021 DOI: 10.2196/30334 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Randomized controlled trial (open-label, waitlist-controlled; study protocol) Peer reviewed |
|---|---|
| Sample size | 20 |
| Population | Patients with refractory posttraumatic stress disorder recruited from a community clinic |
| Intervention | Ketamine |
| Dose | subanesthetic intravenous ketamine |
| Duration | 14 weeks |
| Topics | Esketamine Ketamine PTSD |
| Registration | NCT04771767 |
| Key findings | The protocol proposes that combining subanesthetic intravenous ketamine with therapist-administered internet-based cognitive behavioral therapy will reduce PTSD symptoms more than a waitlist control over 14 weeks, with an expected large effect size (η2=0.14). The authors contend this is the first study to assess e-CBT combined with ketamine for refractory PTSD. |
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.
Trial Registration: ClinicalTrials.gov NCT04771767; https://clinicaltrials.gov/ct2/show/NCT04771767. International Registered Report Identifier (IRRID) PRR1-10.2196/30334
Comparable studies
Other randomized controlled trials on ketamine for PTSD, most cited first.
Citations in the library
Cited by 3
- Toward Synergies of Ketamine and Psychotherapy Frontiers in Psychology March 25, 2022
- Ketamine for Treatment of Posttraumatic Stress Disorder: State of the Field. FOCUS: The Journal of Lifelong Learning in Psychiatry July 2023
- Invisible wounds: Suturing the gap between the neurobiology, conventional and emerging therapies for posttraumatic stress disorder. European Neuropsychopharmacology August 2022
Cites 9
- 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
- The effect of a single dose of intravenous ketamine on suicidal ideation: a systematic review and individual participant data meta-analysis American Journal of Psychiatry October 3, 2017
- 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
and 4 more in the library