A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health

Phase 4

Completed

Conditions: Post Traumatic Stress Disorder
Depression
Anxiety

Interventions: Combination Product: Ketamine-Assisted Psychotherapy (KAP)

Registration Number: NCT05604794

Lead Sponsor: Field Trip Health

Brief Summary: Ketamine-Assisted Psychotherapy (KAP) is a relatively new approach for the treatment of mental health issues, which involves the combination of ketamine, a dissociative anaesthetic with psychedelic properties, and psychotherapy to promote emotional wellbeing. In this study, we investigated the effectiveness of KAP in adult patients coping with mental health. We predicted that clients would experience lasting reductions in psychological distress over time, such as depression, anxiety, and post traumatic stress, that would be detectable up to 6 months after treatment. The results of this study may provide evidence of sustained real-world effects of Ketamine-Assisted Psychotherapy, of interest to patients, clinicians, researchers, and policymakers.

Detailed Description: Background: Ketamine-Assisted Psychotherapy (KAP) has shown positive effects within clinical trial settings and over short-term follow-ups, but sustained effects in real-world treatment settings remain unclear. In this study, we investigated the effectiveness of KAP in adult patients coping with mental health issues. We hypothesized that there would be significant reductions in psychological distress over time.

Objective: To examine treatment effects at 1, 3, and 6 months relative to baseline on depression, anxiety, and post traumatic stress outcomes.

Design: A retrospective intervention-only effectiveness trial.

Setting: KAP was administered across 11 Field Trip Health clinics in North America. Intervention: KAP consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.

Outcomes: Self-reported measures of symptoms of depression, anxiety, and post traumatic stress at 1, 3, and 6 months.

Statistical Analysis: Analyses were by intention to treat. Main analysis was a mixed linear model or growth curve model to estimate change over time per outcome, yielding estimates of mean changes at each endpoint relative to baseline. Secondary analyses included evaluating case reductions (identified by cut-off values) and minimal clinically important differences (MCIDs) at each endpoint relative to baseline.

Significance: This study may provide evidence of sustained real-world effects of Ketamine-Assisted Psychotherapy, of interest to patients, clinicians, researchers, and policymakers.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1806

Inclusion Criteria

Written informed consent
Over the age of 18
Should be psychologically and medically cleared by a psychiatrist, family physician, or treatment team
Diagnosed with Major Depressive Disorder (MDD), Bipolar Depression, Generalized Anxiety Disorder, Obsessive Compulsive Disorder (OCD), and Eating Disorder by a licensed healthcare practitioner (including Field Trip Consultants)
A significant history of trauma and/or formal diagnosis of PTSD as per the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5)
Individuals who have received Electroconvulsive Therapy (ECT) or other neuromodulatory treatments like Transcranial Magnetic Stimulation (TMS)
Individuals reporting suicidal ideation may be included, as suicidal ideation is a symptom of a Major Depressive Episode (MDE)

Exclusion Criteria

Individuals who are unable to consent to the treatment
Pregnant women and nursing mothers

--Note that Post Partum Depression (PPD) can be considered on a case-by-case basis in consultation with the National Medical Director.
There is a relative (not absolute) contraindication for individuals with a Body Mass Index (BMI) of above 35. These clients must be given thorough consideration by the medical team.
Any individual who has met DSM 5 criteria for a Substance Use Disorder in the past 3 months.
- Note that patients with alcohol, opioid, benzodiazepine, cocaine, and amphetamine use disorders need to go through detox (for alcohol/benzodiazepines) and be sober for 4 weeks.
- Note that mild active alcohol, cocaine, and cannabis use can be considered on a case-by-case basis at the comfort level of the treatment team if the client has demonstrated abstaining or significant reduction of use prior to starting treatment.
Daily use of moderate to high doses of benzodiazepines
Individuals who are experiencing psychotic symptoms as part of an MDE (mood congruent/ mood incongruent)
Psychosis: Schizophrenia, Schizoaffective disorder, Bipolar 1 with psychotic features during mania
Active Mania: Bipolar 1 (chronic non-disruptive hypomania is an exception at the discretion of the consultant)
Borderline Personality Disorder
Uncontrolled medical disorders
Physical conditions with negative interaction with ketamine (e.g., metabolic blood disorder)
Individuals with symptomatic acute brain injury within 90 days of serious injury
Individuals diagnosed with moderate to severe sleep apnea
Individuals who are unable to identify a person or service to assure their safe transport to home post treatment

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Clients	Ketamine-Assisted Psychotherapy (KAP)	Adult patients coping with symptoms of depression, anxiety, and post traumatic stress

Primary Outcome Measures

Name	Time	Method
6-item PTSD Checklist (PCL-6)	Change from 3 months compared to baseline	Self-reported measure of post traumatic stress, ranging from 6-30. Higher scores are worse.
9-item Patient Health Questionnaire (PHQ-9)	Change from 3 months compared to baseline	Self-reported measure of depression, ranging from 0-27. Higher scores are worse.
7-item Generalized Anxiety Disorder Measure (GAD-7)	Change from 3 months compared to baseline	Self-reported measure of anxiety, ranging from 0-21. Higher scores are worse.

Secondary Outcome Measures

Name	Time	Method
9-item Patient Health Questionnaire (PHQ-9)	Change from 6 months compared to baseline	Self-reported measure of depression, ranging from 0-27.
7-item Generalized Anxiety Disorder Measure (GAD-7)	Change from 6 months compared to baseline	Self-reported measure of anxiety, ranging from 0-21.
6-item PTSD Checklist (PCL-6)	Change from 6 months compared to baseline	Self-reported measure of post traumatic stress, ranging from 6-30.

Trial Locations

Locations (11): San Diego Centre
🇺🇸
San Diego, California, United States
Atlanta Centre
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Atlanta, Georgia, United States
Washington DC Centre
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Washington, District of Columbia, United States
LA Centre
🇺🇸
Los Angeles, California, United States
Chicago Centre
🇺🇸
Chicago, Illinois, United States
NYC Centre
🇺🇸
New York, New York, United States
Houston Centre
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Houston, Texas, United States
Seattle Centre
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Seattle, Washington, United States
Vancouver Centre
🇨🇦
Vancouver, British Columbia, Canada
Field Trip Health, Toronto Centre
🇨🇦
Toronto, Ontario, Canada
Fredericton Centre
🇨🇦
Fredericton, New Brunswick, Canada