Ketamine Assisted Psychotherapy for Treating Comorbid Chronic Pain and PTSD

ConditionsChronic Pain Posttraumatic Stress Disorder (PTSD)

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18-64

SponsorDr. Yuliya Knyahnytska

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Ketamine Infusion
Drug
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.
Mindfulness-based cognitive therapy
Behavioral
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.

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: KAP groupExperimental treatment 2 interventions

Group B: MT groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Health-Related Quality of Life

Measured using the Short-Form-12 Health Survey (SF-12v2)

Time frame

Enrollment, 1 week pre-treatment, mid-treatment (1month), post-treatment (2months) and follow-up (3months)

Secondary outcomes

Depressive symptoms

Measured using the Montgomery-Asberg Depression Rating Scale (MADRS)

Time frame

At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)

Suicide risk

Suicide risk will be measured using the Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame

At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)

PTSD symptoms

Measured using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5).

Time frame

At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)

Pain Severity

Pain Severity will be measured using the Brief Pain Inventory - Short Form (BPI)

Time frame

At enrollment, 1 week pre-treatment, mid-treatment (1 month), post-treatment (2 month), follow-up (3 months)

Other outcomes

Baseline Characteristics

To describe the study population, the investigators will capture the following through the survey: age, sex, gender, duration of pain, locations of pain, current work status, military status, education, income, and ethnicity.

Time frame

Enrollment

Concomitant medication

A list of medication currently used will be provided by the participants. Participants will be asked to talk the the research team before making any changes or start new medications during study period.

Time frame

At enrollment and follow-up (3 months)