Combined Ketamine and eCBT Intervention for PTSD

Queen's University16 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Post-Traumatic Stress Disorder

Interventions

KetamineDRUG

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

Online Trauma-Focused Cognitive Behavioural TherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Queen's University

Kingston, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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.