Ignite Creation Date:
2024-05-06 @ 6:15 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05604794
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2022-10-12
Brief Title:
A Retrospective Effectiveness Trial of Ketamine-Assisted Psychotherapy in Adult Patients Coping With Mental Health
Sponsor:
Field Trip Health
Organization:
Field Trip Health
Study Overview
Official Title:
Retrospective Review of Ketamine Assisted Psychotherapy Program on Mental Health at Field Trip Health Centres in North America
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None