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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,806
KAP consisting of 4-6 guided ketamine sessions with psychotherapy-only visits after dose 1 and 2 and then after every 2 subsequent doses.
LA Centre
Los Angeles, California, United States
San Diego Centre
San Diego, California, United States
Washington DC Centre
Washington D.C., District of Columbia, United States
Atlanta Centre
Atlanta, Georgia, United States
Chicago Centre
Chicago, Illinois, United States
NYC Centre
New York, New York, United States
Houston Centre
Houston, Texas, United States
Seattle Centre
Seattle, Washington, United States
Vancouver Centre
Vancouver, British Columbia, Canada
Fredericton Centre
Fredericton, New Brunswick, Canada
...and 1 more locations
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27. Higher scores are worse.
Time frame: Change from 3 months compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21. Higher scores are worse.
Time frame: Change from 3 months compared to baseline
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30. Higher scores are worse.
Time frame: Change from 3 months compared to baseline
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27.
Time frame: Change from 1 month compared to baseline
9-item Patient Health Questionnaire (PHQ-9)
Self-reported measure of depression, ranging from 0-27.
Time frame: Change from 6 months compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21.
Time frame: Change from 1 month compared to baseline
7-item Generalized Anxiety Disorder Measure (GAD-7)
Self-reported measure of anxiety, ranging from 0-21.
Time frame: Change from 6 months compared to baseline
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30.
Time frame: Change from 1 month compared to baseline
6-item PTSD Checklist (PCL-6)
Self-reported measure of post traumatic stress, ranging from 6-30.
Time frame: Change from 6 months compared to baseline
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