Clinical trial NCT07009158: Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD
Official title: Ketamine Assisted Psychotherapy to Improve Quality of Life in Veterans and Civilians With Comorbid Chronic Pain and Posttraumatic Stress Disorder: an Open-label Randomized Controlled Trial.
Conditions: Chronic Pain
Posttraumatic Stress Disorder (PTSD)
Summary: The goal of this pilot study is to evaluate the feasibility of conducting a clinical trial assessing if ketamine infusions combined to mindfulness therapy works better than psychotherapy alone to treat chronic pain and PTSD in adults living with both conditions. The objectives of the pilot study are to 1) assess the feasibility of the trial methods and 2) assess the feasibility and tolerability of ketamine treatment in combination with psychotherapy. The main questions the future full trial would aim to answer are:
* Does the combination of ketamine infusion treatment and mindfulness therapy improve the quality of life in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?"
* Does the combination of ketamine infusion treatment and mindfulness therapy improve disability, and depressive, PTSD and pain symptoms in adults living with both chronic pain and PTSD more effectively than mindfulness therapy alone?"
* Does implementing a brief ketamine infusion protocol safe and tolerable to treat chronic pain and PTSD?
Researchers will compare ketamine infusion treatment combined with mindfulness therapy to mindfulness therapy alone to see if the combined treatment works better to treat chronic pain and PTSD.
Participants will:
* Attend 6 visits with a research team member to complete assessments and questionnaires.
* Attend 4 ketamine treatment over 2 weeks, if allocated to the experimental group.
* Attend 8 mindfulness therapy group sessions online (1 per week).
* Log mindfulness exercises completed during the study period.
Interventions:
description: Ketamine hydrochloride (DIN: 02246795, 02246796) will be administered over 40-min intravenous (IV) infusion twice per week on non-consecutive days for the first two weeks of study treatment (four treatment sessions in total). We will use a standard dose of 0.5mg/kg which has demonstrated efficacy in safety in individuals with PTSD.
name: Ketamine Infusion
type: Drug
description: The Mindfulness-based cognitive therapy (MBCT) will be an 8-week group program adapted from a protocol developed to treat PTSD to include psychoeducation about chronic pain and mutual maintenance factors through which chronic pain and PTSD facilitate each other. The MBCT group will be delivered by trained professionals in weekly 2-hour sessions through Microsoft Teams. The 8-week program will include 1) mindfulness techniques; 2) psychoeducation regarding chronic pain, PTSD and stress responses; 3) psychoeducation on mutual maintenance factors that contribute to negative interactions between pain and PTSD symptoms, 4) promoting mindful awareness of these factors' impact on daily life and 5) feedback and supportive group discussion of exercises. Participants will be asked to complete daily mindfulness exercises between sessions to practice skills learned for a recommended minimum of 20 minutes per day.
name: Mindfulness-based cognitive therapy
type: Behavioral
Study arms:
design_group_description: The Ketamine-assisted psychotherapy (KAP) group will receive 4 ketamine infusion treatments and 8 sessions of mindfulness therapy.
design_group_title: KAP group
design_group_type: Experimental
design_group_description: The mindfulness therapy (MT) group will receive only the psychotherapy treatment (8 sessions mindfulness therapy).
design_group_title: MT group
design_group_type: Active Comparator
Sponsor: Queen's University
Collaborators: Kingston Health Sciences Centre
Providence Care Hospital
Drug name mappings:
name: 盐酸氯胺酮
lang: CN
name: Ketamine Hydrochloride
lang: EN
name: ケタミン塩酸塩
lang: JP