Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial

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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 ( η ² =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

Related collections

Most cited references 54

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A new depression scale designed to be sensitive to change

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The construction of a depression rating scale designed to be particularly sensitive to treatment effects is described. Ratings of 54 English and 52 Swedish patients on a 65 item comprehensive psychopathology scale were used to identify the 17 most commonly occurring symptoms in primary depressive illness in the combined sample. Ratings on these 17 items for 64 patients participating in studies of four different antidepressant drugs were used to create a depression scale consisting of the 10 items which showed the largest changes with treatment and the highest correlation to overall change. The inner-rater reliability of the new depression scale was high. Scores on the scale correlated significantly with scores on a standard rating scale for depression, the Hamilton Rating Scale (HRS), indicating its validity as a general severity estimate. Its capacity to differentiate between responders and non-responders to antidepressant treatment was better than the HRS, indicating greater sensitivity to change. The practical and ethical implications in terms of smaller sample sizes in clinical trials are discussed.

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The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.

Kelly Posner, Gregory Brown, Barbara Stanley … (2011)

Research on suicide prevention and interventions requires a standard method for assessing both suicidal ideation and behavior to identify those at risk and to track treatment response. The Columbia-Suicide Severity Rating Scale (C-SSRS) was designed to quantify the severity of suicidal ideation and behavior. The authors examined the psychometric properties of the scale. The C-SSRS's validity relative to other measures of suicidal ideation and behavior and the internal consistency of its intensity of ideation subscale were analyzed in three multisite studies: a treatment study of adolescent suicide attempters (N=124); a medication efficacy trial with depressed adolescents (N=312); and a study of adults presenting to an emergency department for psychiatric reasons (N=237). The C-SSRS demonstrated good convergent and divergent validity with other multi-informant suicidal ideation and behavior scales and had high sensitivity and specificity for suicidal behavior classifications compared with another behavior scale and an independent suicide evaluation board. Both the ideation and behavior subscales were sensitive to change over time. The intensity of ideation subscale demonstrated moderate to strong internal consistency. In the adolescent suicide attempters study, worst-point lifetime suicidal ideation on the C-SSRS predicted suicide attempts during the study, whereas the Scale for Suicide Ideation did not. Participants with the two highest levels of ideation severity (intent or intent with plan) at baseline had higher odds for attempting suicide during the study. These findings suggest that the C-SSRS is suitable for assessment of suicidal ideation and behavior in clinical and research settings.

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A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression.

Carlos A Zarate, Jaskaran Singh, Paul Carlson … (2006)

Existing therapies for major depression have a lag of onset of action of several weeks, resulting in considerable morbidity. Exploring pharmacological strategies that have rapid onset of antidepressant effects within a few days and that are sustained would have an enormous impact on patient care. Converging lines of evidence suggest the role of the glutamatergic system in the pathophysiology and treatment of mood disorders. To determine whether a rapid antidepressant effect can be achieved with an antagonist at the N-methyl-D-aspartate receptor in subjects with major depression. A randomized, placebo-controlled, double-blind crossover study from November 2004 to September 2005. Mood Disorders Research Unit at the National Institute of Mental Health. Patients Eighteen subjects with DSM-IV major depression (treatment resistant). After a 2-week drug-free period, subjects were given an intravenous infusion of either ketamine hydrochloride (0.5 mg/kg) or placebo on 2 test days, a week apart. Subjects were rated at baseline and at 40, 80, 110, and 230 minutes and 1, 2, 3, and 7 days postinfusion. Main Outcome Measure Changes in scores on the primary efficacy measure, the 21-item Hamilton Depression Rating Scale. Subjects receiving ketamine showed significant improvement in depression compared with subjects receiving placebo within 110 minutes after injection, which remained significant throughout the following week. The effect size for the drug difference was very large (d = 1.46 [95% confidence interval, 0.91-2.01]) after 24 hours and moderate to large (d = 0.68 [95% confidence interval, 0.13-1.23]) after 1 week. Of the 17 subjects treated with ketamine, 71% met response and 29% met remission criteria the day following ketamine infusion. Thirty-five percent of subjects maintained response for at least 1 week. Robust and rapid antidepressant effects resulted from a single intravenous dose of an N-methyl-D-aspartate antagonist; onset occurred within 2 hours postinfusion and continued to remain significant for 1 week.

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Author and article information

Contributors

Aaron Emile Philipp-Muller:

ORCID: https://orcid.org/0000-0002-9974-8726

Centre for Neuroscience StudiesQueen's UniversityBotterell Hall, 18 Stuart St.Kingston, ON, K7L 3N6Canada1 (613) 544 33101 (613) 544 966619aepm1@queensu.ca

Journal

Journal ID (nlm-ta): JMIR Res Protoc

Journal ID (iso-abbrev): JMIR Res Protoc

Journal ID (publisher-id): ResProt

Title: JMIR Research Protocols

Publisher: JMIR Publications (Toronto, Canada )

ISSN (Electronic): 1929-0748

Publication date Collection: July 2021

Publication date (Electronic): 20 July 2021

Volume: 10

Issue: 7

Electronic Location Identifier: e30334

Affiliations

[1 ] Centre for Neuroscience Studies Queen's University Kingston, ON Canada

[2 ] Department of Psychiatry Queen's University Kingston, ON Canada

Author notes

Corresponding Author: Aaron Emile Philipp-Muller 19aepm1@ 123456queensu.ca

Author information

Aaron Emile Philipp-Muller https://orcid.org/0000-0002-9974-8726

Taras Reshetukha https://orcid.org/0000-0003-0494-8053

Gustavo Vazquez https://orcid.org/0000-0002-2918-3336

Roumen Milev https://orcid.org/0000-0001-6884-171X

Dawn Armstrong https://orcid.org/0000-0001-7907-9740

Jasleen Jagayat https://orcid.org/0000-0002-1709-0773

Nazanin Alavi https://orcid.org/0000-0001-8710-6067

Article

Publisher ID: v10i7e30334

DOI: 10.2196/30334

PMC ID: 8335614

PubMed ID: 34092549

SO-VID: 80acc5d0-0d13-4fe6-a833-f11be9f6fbcc

Copyright © ©Aaron Emile Philipp-Muller, Taras Reshetukha, Gustavo Vazquez, Roumen Milev, Dawn Armstrong, Jasleen Jagayat, Nazanin Alavi. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 20.07.2021.

License:

This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

History

Date received : 11 May 2021

Date revision requested : 17 May 2021

Date revision received : 31 May 2021

Date accepted : 1 June 2021

Custom metadata

ext-peer-rev This paper was peer reviewed by the Queen’s University (Canada) Department of Psychiatry Internal Research Grant Review Board. See the Multimedia Appendix for the peer-review report;

Keywords: mental health,ptsd,psychotherapy,cognitive behavioral therapy,online,internet,electronic,virtual,mental health care,ketamine

Data availability:

Keywords: mental health, ptsd, psychotherapy, cognitive behavioral therapy, online, internet, electronic, virtual, mental health care, ketamine

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Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial

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Abstract

Background

Objective

Methods

Results

Conclusions

Trial Registration

International Registered Report Identifier (IRRID)

Related collections

JMIR: Research Protocols

Most cited references 54

A new depression scale designed to be sensitive to change

The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.

A randomized trial of an N-methyl-D-aspartate antagonist in treatment-resistant major depression.

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Contributors

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Affiliations

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Article

History

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Custom metadata

Comments

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Cited by 2

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