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Combined Ketamine and eCBT Intervention for PTSD

Primary Purpose

Post-Traumatic Stress Disorder

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Ketamine

Online Trauma-Focused Cognitive Behavioural Therapy

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Ketamine, Cognitive Behavioral Therapy, Online Cognitive Behavioral Therapy, Pharmacologically enhanced psychotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation.
Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms.
Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate.
Participants must speak and read English, and will have consistent and reliable access to the internet.
Patients with suicidal ideation will be included.
Patients with a history of substance abuse will be included (except for opioid use disorder).

Exclusion Criteria:

Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.

Sites / Locations

Queen's UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ketamine + eCBT

Control

Arm Description

Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine

Participants are in a control condition receiving treatment as usual, during which time they will not receive the experimental treatment and will have no change in their treatment regimen.

Outcomes

Primary Outcome Measures

Change in Scores on the Clinician Administered PTSD Scale for DSM-5

Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.

Secondary Outcome Measures

Change in Scores on the Montgomery Asberg Depression Rating Scale

Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.

Change in Scores on the Columbia Suicide Severity Rating Scale

Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.

Change in Scores on the Sheehan Disabilities Scale

A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.

Change in Scores on the Global Assessment of Functioning

Assessing the patient's overall capacity to handle life's challenges; score representing the mildest/lack of symptoms: 100; score representing the most severe symptoms: 1.

Full Information

NCT ID

NCT04771767

First Posted

November 19, 2020

Last Updated

August 8, 2022

Sponsor

Queen's University

1. Study Identification

Unique Protocol Identification Number

NCT04771767

Brief Title

Combined Ketamine and eCBT Intervention for PTSD

Official Title

Assessing a Combined Ketamine and Online Cognitive Behavioural Therapy Intervention for Treatment Resistant Post-Traumatic Stress Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 1, 2021 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Queen's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.

Detailed Description

OBJECTIVES (i) To introduce a previously untreated patient population with PTSD to new therapeutic options. (ii) To provide new insights into the functional role of Glutamate in affective disorders as well as in learning and memory. (iii) To explore the utility of pharmacologically-enhanced psychotherapy. OUTLINE The present study is an open label randomized control trial assessing the efficacy of a combined treatment of sub-anaesthetic IV Ketamine in conjunction with online CBT (eCBT). In the study, 16 participants with refractory PTSD will be assigned either to an experimental group receiving a combination of Ketamine and eCBT over 12 weeks, or they will be assigned to a 12-week control group. Both groups will be assessed for symptoms of PTSD and comorbid disorders before treatment, at 2 midway points (4 and 8 weeks), and at the end of the 12 week experimental period. Symptoms of PTSD and comorbid disorders for participants in the experimental group are expected to improve significantly more than participants in the control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-Traumatic Stress Disorder

Keywords

Ketamine, Cognitive Behavioral Therapy, Online Cognitive Behavioral Therapy, Pharmacologically enhanced psychotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Participants diagnosed with PTSD will be assigned either to the experimental treatment or a control. Data will be collected from participants in both groups at the same 4 time-points.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ketamine + eCBT

Arm Type

Experimental

Arm Description

Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants are in a control condition receiving treatment as usual, during which time they will not receive the experimental treatment and will have no change in their treatment regimen.

Intervention Type

Drug

Intervention Name(s)

Ketamine

Other Intervention Name(s)

Ketalar

Intervention Description

Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.

Intervention Type

Behavioral

Intervention Name(s)

Online Trauma-Focused Cognitive Behavioural Therapy

Other Intervention Name(s)

eCBT, TF-CBT

Intervention Description

Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.

Primary Outcome Measure Information:

Title

Change in Scores on the Clinician Administered PTSD Scale for DSM-5

Description

Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.

Time Frame

0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start

Secondary Outcome Measure Information:

Title

Change in Scores on the Montgomery Asberg Depression Rating Scale

Description

Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.

Time Frame

0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start

Title

Change in Scores on the Columbia Suicide Severity Rating Scale

Description

Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.

Time Frame

0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start

Title

Change in Scores on the Sheehan Disabilities Scale

Description

A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.

Time Frame

0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start

Title

Change in Scores on the Global Assessment of Functioning

Description

Assessing the patient's overall capacity to handle life's challenges; score representing the mildest/lack of symptoms: 100; score representing the most severe symptoms: 1.

Time Frame

0 weeks from start, 4 weeks from start, 8 weeks from start, and 12 weeks from start

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of PTSD by a psychiatrist on the team using the Clinician Administered PTSD Scale (CAPS-5) with a score of at least 50 and a medium presentation. Patients will have received at least 2 different types of prior treatment, both of which produced less than a 50% reduction in the participant's symptoms. Participants with hypertension or cardiovascular disease must be receiving stable treatment to participate. Participants must speak and read English, and will have consistent and reliable access to the internet. Patients with suicidal ideation will be included. Patients with a history of substance abuse will be included (except for opioid use disorder). Exclusion Criteria: Hypomanic/manic episodes, bipolar disorder, acute psychosis, opioid use disorder, treatment with Naltrexone, pregnancy, postpartum, breastfeeding, untreated hypertension, cardiovascular disease, ASPD, active homicidal ideation, and general noncompliance with the study protocol.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Aaron E Philipp-Muller, B.Sc.

Phone

416-939-3164

19aepm1@queensu.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Taras Reshetukha, MD

Organizational Affiliation

Queen's University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Queen's University

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 3N6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aaron Philipp-Muller, B.Sc.

Phone

4169393164

19aepm1@queensu.ca

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All participant screening and assessment data will be made available once deidentified.

IPD Sharing Time Frame

Made available in June 2024. No end date.

IPD Sharing Access Criteria

Open access

Citations:

PubMed Identifier

30532790

Citation

Alavi N, Stefanoff M, Hirji A, Khalid-Khan S. Cognitive Behavioural Therapy through PowerPoint: Efficacy in an Adolescent Clinical Population with Depression and Anxiety. Int J Pediatr. 2018 Nov 8;2018:1396216. doi: 10.1155/2018/1396216. eCollection 2018.

Results Reference

background

PubMed Identifier

24740528

Citation

Feder A, Parides MK, Murrough JW, Perez AM, Morgan JE, Saxena S, Kirkwood K, Aan Het Rot M, Lapidus KA, Wan LB, Iosifescu D, Charney DS. Efficacy of intravenous ketamine for treatment of chronic posttraumatic stress disorder: a randomized clinical trial. JAMA Psychiatry. 2014 Jun;71(6):681-8. doi: 10.1001/jamapsychiatry.2014.62.

Results Reference

background

PubMed Identifier

28043916

Citation

Girgenti MJ, Ghosal S, LoPresto D, Taylor JR, Duman RS. Ketamine accelerates fear extinction via mTORC1 signaling. Neurobiol Dis. 2017 Apr;100:1-8. doi: 10.1016/j.nbd.2016.12.026. Epub 2016 Dec 30.

Results Reference

background

PubMed Identifier

24338345

Citation

Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.

Results Reference

background

PubMed Identifier

29563072

Citation

Pradhan B, Mitrev L, Moaddell R, Wainer IW. 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. Biochim Biophys Acta Proteins Proteom. 2018 Jul;1866(7):831-839. doi: 10.1016/j.bbapap.2018.03.006. Epub 2018 Mar 18.

Results Reference

background

PubMed Identifier

34092549

Citation

Philipp-Muller AE, Reshetukha T, Vazquez G, Milev R, Armstrong D, Jagayat J, Alavi N. Combining Ketamine and Internet-Based Cognitive Behavioral Therapy for the Treatment of Posttraumatic Stress Disorder: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 20;10(7):e30334. doi: 10.2196/30334.

Results Reference

derived

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Combined Ketamine and eCBT Intervention for PTSD

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