Retrospective Review of Ketamine Assisted Psychotherapy Program on Mental Health at Field Trip Health Centres in North America
Phase: PHASE4
Conditions: Depression, Anxiety, Post Traumatic Stress Disorder
Sponsor: Field Trip Health

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Title: Proposal for Retrospective Review of Ketamine Assisted Psychotherapy Program on Mental 
Health at Field Trip Health Centres in North America 
 
Author(s): Ryan Yermus MD, Field Trip Health; Chris Lo PhD, University of Toronto  
Date: Oct 14, 2022 
Version: 1.4 
Funding: Field Trip Health 
 
Introduction 
Psychedelics are again at the forefront of psychiatric research as the search intensifies for more 
effective interventions to address emotional disturbances beyond conventional treatment 
(Carhart-Harris et al., 2017). Several psychedelics have been identified as having breakthrough 
potential when administered in combination with psychotherapy, including ketamine-assisted 
psychotherapy (KAP) (Ezquerra-Romano et al., 2018; Greenway et al., 2020; Luoma et al., 2020; 
Reiff et al., 2020). Overall the clinical trials evidence for psychedelic-assisted therapies is early 
(Wheeler et al., 2020) and multiple randomised controlled trials (RCTs) are underway around 
the world (see clinicaltrials.gov).  
 
Although RCTs can best answer questions of safety and efficacy, there remains an urgent need 
to clarify the real-world effectiveness of psychedelic-assisted therapies. Field Trip Health 
administers KAP for adult clients coping with mental health. KAP consists of 4-6 guided 
ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 
subsequent doses. 
This proposal is for a retrospective intervention-only effectiveness trial based on review of Field 
Trip Health patient outcomes across its North American centres. Its objectives are: 1. to 
characterise baseline patient characteristics; 2. to identify treatment variation; 3. to determine 
the trajectory of mental health outcomes; and 4. to estimate effect sizes associated with 
treatment. We hypothesized sustained reductions in depression, anxiety, and post traumatic 
stress over time.  
 
Method 
Sample and Procedure 
Patients treated at Field Trip Health are initially assessed by a psychiatrist or a psychiatric nurse 
practitioner to determine appropriateness for treatment. Eligibility criteria are as follows. 
 
• Inclusion Criteria: 
o Written informed consent 
o Over the age of 18 
o Should be psychologically and medically cleared by a psychiatrist, family 
physician, or treatment team 
o Diagnosed with Major Depressive Disorder (MDD), Bipolar Depression, 
Generalized Anxiety Disorder, Obsessive Compulsive Disorder (OCD), and Eating 

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Disorder by a licensed healthcare practitioner (including Field Trip Consultants) 
o A significant history of trauma and/or formal diagnosis of PTSD as per the 
Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) 
o Individuals who have received Electroconvulsive Therapy (ECT) or other 
neuromodulatory treatments like Transcranial Magnetic Stimulation (TMS) 
o Individuals reporting suicidal ideation may be included, as suicidal ideation is a 
symptom of a Major Depressive Episode (MDE) 
 
• Exclusion Criteria: 
o Individuals who are unable to consent to the treatment 
o 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. 
o 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. 
o 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. 
o Daily use of moderate to high doses of benzodiazepines 
o Individuals who are experiencing psychotic symptoms as part of an MDE (mood 
congruent/ mood incongruent) 
o Psychosis: Schizophrenia, Schizoaffective disorder, Bipolar 1 with psychotic 
features during mania 
o Active Mania: Bipolar 1 (chronic non-disruptive hypomania is an exception at the 
discretion of the consultant) 
o Borderline Personality Disorder 
o Uncontrolled medical disorders 
o Physical conditions with negative interaction with ketamine (e.g., metabolic 
blood disorder) 
o Individuals with symptomatic acute brain injury within 90 days of serious injury 
o Individuals diagnosed with moderate to severe sleep apnea 
o Individuals who are unable to identify a person or service to assure their safe 
transport to home post treatment 

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As a part of the intake process of the program, patients provide written informed consent and 
complete questionnaires via a Health Insurance Portability and Accountability Act (HIPAA) and 
Personal Health Information Protection Act (PHIPA) compliant Electronic Medical Records 
(EMR) system.  
 
Questions include information on demographics, past medical history as well as standardized 
mental health questionnaires. Patients are also encouraged to complete these scales at several 
additional points during the treatment program and then at 1, 3, and 6 months after program 
completion. Data will be reviewed from patients who were treated with KAP across 11 Field 
Trip Health locations across North America from March 2020 to June 2022.  
 
These locations include:  
1) Toronto, ON, Canada 
2) Vancouver, BC, Canada 
3) Fredericton, NB, Canada 
4) New York City, NY, USA 
5) Atlanta, GA, USA 
6) Chicago, IL, USA 
7) Houston, TX, USA 
8) Seattle, WA, USA 
9) Santa Monica, CA, USA 
10) San Diego, CA, USA 
11) Washington, DC, USA 
 
Data Handling 
The full clinical dataset is managed by a data administrator who will collate the assessments 
and de-identify the data so that no personal identifying information remains. This de-identified 
dataset will then be analysed by research team members. Full clinical data is held on encrypted 
servers with password protection and accessible only to internal clinical staff. Only research 
team members will be allowed access to the de-identified research dataset which will also be 
kept on password protected servers and computers.  
 
Should a data breach or leak should occur, our data mitigation plan is to contact Veritas Internal 
Review Board (IRB) to inform them of the breach, assess the extent of the breach, and 
determine what steps can be taken to address the situation. We will also plan to inform 
affected clients of the event and the actions being taken. 
 
Measures of Interest 
a) Demographic variables, including age and gender.  
b) Medical variables, including main diagnosis and length of illness. 
c) Treatment-related variables, including number and timing of ketamine sessions, number 
and timing of psychotherapeutic sessions, and site.  
d) Primary clinical outcomes were:  

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i. 
Change in depression at 3 months relative to baseline assessed by 9-item Patient 
Health Questionnaire (PHQ-9) (Kroenke et al., 2001);  
ii. 
Change in anxiety at 3 months relative to baseline assessed by 7-item 
Generalized Anxiety Disorder measure (GAD-7) (Spitzer et al., 2006);  
iii. 
Change in post traumatic stress at 3 months relative to baseline by 6-item Post 
Traumatic Stress Disorder (PTSD) Checklist (PCL-6) (Lang & Stein., 2005). 
e) Secondary clinical outcomes were: 
i. 
Change in depression at 1 month relative to baseline assessed by  PHQ-9;  
ii. 
Change in anxiety at 1 month relative to baseline assessed by GAD-7; 
iii. 
Change in post traumatic stress at 1 month relative to baseline assessed by PCL-6; 
iv. 
Change in depression at 6 months relative to baseline assessed by PHQ-9;  
v. 
Change in anxiety at 6 months relative to baseline assessed by GAD-7; 
vi. 
Change in post traumatic stress at 6 months relative to baseline assessed by PCL-6. 
 
Statistical Analysis 
Descriptive statistics will characterize the sample. This will include an analysis of variations in 
treatment delivery and the extent of missing values across measurement occasions. Analysis of 
treatment effects is by intention to treat. The main analysis will be mixed linear models to plot 
the normative patient trajectories or growth curves for each outcome, producing estimates of 
mean changes at each endpoint (i.e. 1, 3, and 6 months) relative to baseline (Bell et al., 2013). 
Cohen's d will be our standardised measure of effect size. By convention, values of d = 0.2, 0.5, 
and 0.8 correspond to small, medium, and large effects.  
Secondary analyses will include evaluating case reductions (identified by validated cut-off 
values relevant to each measure) and proportions of patients reporting minimal clinically 
important differences (MCIDs) at each endpoint relative to baseline. Additional analyses may 
include a sensitivity analysis involving multiple imputation of missing values to examine the 
stability of estimates. Demographic, medical, and treatment-related variables may be tested as 
predictive factors.  
 
Impact 
Field Trip Health's large-scale dataset may provide real-world benchmarks concerning the 
sustained benefits of ketamine-assisted psychotherapy. Given the scale of interest by 
policymakers, clinicians, researchers, and patients, these findings may be suitable for 
publication in a high impact journal, offering scientific validation of Field Trip Health's 
therapeutic product.  
 
References 
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South Carolina. 
 

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