Explore / Preregistration
Preregistration

Trustworthiness of systematic reviews with meta‑analyses of randomised controlled trials of psychedelic-assisted psychotherapy: a protocol

OSFOct 31, 2025

Abstract

This project aims to evaluate the trustworthiness of systematic reviews with meta‑analyses (SR-MAs) of randomised controlled trials (RCTs) of psychedelic-assisted psychotherapy (PAP) by: 1. assessing their risk of bias using the ROBIS tool (domain‑level and overall judgment) and, where applicable, the Risk of Bias in Network Meta-Analysis (RoB-NMA) tool; 2. documenting how authors identified and handled: 2.1. clinical diversity, reflecting differences across settings, populations, interventions, and outcomes among the included RCTs, with a particular focus on the psychotherapy component as well as any related contextual diversity (e.g., therapist involvement/credentials, preparation/support/integration, therapy dose/contact hours, group vs individual, manualisation, set/setting features); 2.2. methodological heterogeneity, operationalised as differences in risk of bias across included RCTs; 2.3. statistical heterogeneity, referring to variation in quantitative results across included RCTs, typically assessed within a meta-analysis using measures such as I² or τ²; 3. analysing the presence of spin in SR-MAs, defined as discrepancies between favourable abstract conclusions and primary outcome results; 4. documenting conflicts of interest (COI) and funding to verify whether the SR-MAs were independent of any commercial influence or obvious allegiance bias. Together, these elements provide a methods-first critique of PAP evidence syntheses that will clarify how authors assessed primary studies and synthesised evidence, making these methodological approaches more transparent and interpretable for users of this literature.

Topics & conditions

Detected automatically by Psychedelic Commons from the title and abstract, not labels from the source. They may be incomplete.

Psychedelics

Keywords

clinical diversityconflicts of interestevidence-based practiceevidence synthesisheterogeneitymental healthmeta-analysismeta-researchmethodological heterogeneityoverview of reviewsPAPpsychedelic-assisted psychotherapypsychotherapyrandomised controlled trialsreproducibility

Psychedelic Commons aggregates metadata from open sources and links back to the original. Rights remain with the authors and publishers. Something wrong with this record? Report a problem.