Assessment of PTSD symptoms for diagnosis and severity; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 120.
Combined Ketamine and eCBT Intervention for PTSD
Brief Summary
An open label RCT assessing the efficacy of a combined treatment approach for PTSD, using Ketamine infusions and online Cognitive Behavioural Therapy.
Intervention / Treatment
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.
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Ketamine (DRUG)Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
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Online Trauma-Focused Cognitive Behavioural Therapy (BEHAVIORAL)Participants will enrol in a 12-week online CBT program mirroring in-person trauma-focused CBT.
Condition or Disease
- Post-Traumatic Stress Disorder
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Recruiting |
| Study results: | No Results Available |
| Age: | 18 Years to 65 Years |
| Enrollment: | 16 (ESTIMATED) |
| Allocation: | Non-Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Aug 01, 2021 | ACTUAL |
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| Primary Completion: | Mar 31, 2024 | ESTIMATED |
| Completion Date: | Mar 31, 2024 | ESTIMATED |
| Study First Posted: | Feb 25, 2021 | ACTUAL |
| Last Updated: | Aug 08, 2022 |
Sponsors / Collaborators
Lead Sponsor:
Queen's University
Responsible Party:
N/A
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.
(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.
Participant Groups
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Over 12 weeks, participants receive weekly sessions of asynchronous online cognitive-behavioural therapy as well as 6 sub-anesthetic infusions of Ketamine
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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.
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 65 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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.
* 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.
This clinical trial is recruiting
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Primary Outcomes
Secondary Outcomes
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Measure of depression; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 60.
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Measuring thoughts, feelings, and behaviours associated with suicide; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 6.
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A brief, patient rated measure of disability and impairment; score representing the mildest/lack of symptoms: 0; score representing the most severe symptoms: 44.
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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.
More Details
| NCT Number: | NCT04771767 |
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| Other IDs: | 14521759 |
| Study URL: | https://clinicaltrials.gov/study/NCT04771767 |
Last updated: Sep 29, 2023