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Record W4317207628 · doi:10.1101/2023.01.11.23284248

Ketamine-assisted psychotherapy provides lasting and effective results in the treatment of depression, anxiety and post traumatic stress disorder at 3 and 6 months: Findings from a large single-arm retrospective effectiveness trial

2023· preprint· en· W4317207628 on OpenAlexaff
Ryan Yermus, Michael Verbora, Sidney H. Kennedy, Robert McMaster, Sarah Kratina, Elizabeth Wolfson, Ben Medrano, Nathan Bryson, Nabid Zaer, John Bottos, Varun Setlur, Christopher Lo

Bibliographic record

VenuemedRxiv · 2023
Typepreprint
Languageen
FieldMedicine
TopicTreatment of Major Depression
Canadian institutionsSeneca PolytechnicPublic Health OntarioUniversity of TorontoMcMaster University
Fundersnot available
KeywordsAnxietyDepression (economics)Psychological interventionMedicineKetamineMental healthPsychiatryRandomized controlled trialClinical psychologyInternal medicine

Abstract

fetched live from OpenAlex

Abstract IMPORTANCE Ketamine-Assisted Psychotherapy (KAP) is an emerging treatment option to alleviate treatment resistant affective disorders, but its long term effectiveness remains unclear. OBJECTIVE To examine the treatment effects of KAP on anxiety, depression, and post traumatic stress disorder (PTSD) at 1, 3, and 6 months post treatment. DESIGN, SETTING, AND PARTICIPANTS This retrospective single-arm effectiveness trial included self-reported outcomes from 1806 adults with a history of depression, anxiety, or PTSD who had not responded to prior treatment interventions and received KAP administered across 11 Field Trip Health clinics in North America between March 13, 2020 and June 16, 2022. INTERVENTION KAP consisting of 4-6 guided ketamine sessions (administered via intramuscular injection or sublingual lozenge) with psychotherapy-only visits after doses 1 and 2 and then after every 2 subsequent doses. Mean number of doses administered was 4, SD=3, and mean number of psychotherapy sessions was 3, SD=2. MAIN OUTCOMES AND MEASURES Primary outcomes were changes in depression, anxiety, and PTSD at 3 months relative to baseline, assessed respectively using the 9-item Patient Health Questionnaire (PHQ-9), the 7-item Generalized Anxiety Disorder measure (GAD-7), and the 6-item PTSD Checklist (PCL-6). Secondary outcomes were changes at 1 and 6 months relative to baseline. RESULTS Large treatment effects were detected at 3 months (d’s=0.75-0.86) that were sustained at 6 months (d’s=0.61-0.73). Case reductions (identified based on cut-off values) ranged from 39-41% at 3 months and 29-37% at 6 months. 50-75% reported a minimal clinically important difference at 3 months and 48-70% at 6 months. CONCLUSIONS AND RELEVANCE KAP produced sustained reductions in anxiety, depression, and PTSD, with symptom improvement lasting well beyond the duration of dosing sessions. These effects extended to as much as 5 months after the last KAP session. Given the growing mental health care crises and the need for effective therapies and models of care, especially for intractable psychiatric mood related disorders, these data would support the consideration of KAP as a viable alternative. Further prospective clinical research should be undertaken to provide further evidence on the safety and effectiveness of ketamine within a psychotherapeutic context. TRIAL REGISTRATION Clinicaltrials.gov Identifier NCT05604794 Key Points Question What are the lasting effects of Ketamine-Assisted Psychotherapy on psychological distress? Findings In this retrospective single-arm effectiveness trial that included 1806 adults, there were large effect sizes at 3 months on depression, anxiety, and post traumatic stress (d’s=0.75-0.86) that were sustained at 6 months. Meaning These findings suggest that Ketamine-Assisted Psychotherapy is an effective treatment option with substantial clinical benefits detected up to half a year.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame machine prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.

metaresearch head score (Codex)0.008
metaresearch head score (Gemma)0.013
Version: metacan-v3-hybrid-931329e0061cValidation status: machine_predicted_unvalidated
Candidate categoriesnone
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Non-randomized trial · Consensus signal: none
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.008
Threshold uncertainty score0.042

Distilled classifier scores by category (both heads)

CategoryCodexGemma
Metaresearch0.0080.013
Meta-epidemiology (narrow)0.0010.000
Meta-epidemiology (broad)0.0020.002
Bibliometrics0.0000.001
Science and technology studies0.0010.001
Scholarly communication0.0010.001
Open science0.0010.000
Research integrity0.0010.001
Insufficient payload (model declined to judge)0.0020.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.026
GPT teacher head0.298
Teacher spread0.272 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.

The models applied no category: nothing in the taxonomy fit this work.
Study designNon-randomized trial
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations2
Published2023
Admission routes1
Has abstractyes

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