Background: The classical psychedelics, psilocybin, peyote, ayahuasca/ N,N-dimethyltryptamine, and lysergic acid diethylamide are considered promising new treatments for psychiatric illnesses, such as depression, anxiety, addiction, and obsessive-compulsive disorders. However, their profound and characteristic subjective effects raise concern for distinctive biases in randomized clinical trials. Methods: We performed a systematic literature search to identify all clinical trials on classical psychedelics with patient populations to examine descriptive data and determine the risk of bias. Two independent reviewers searched three databases (PubMed, Embase, and APA PsycNet) and extracted information on study design, study population, use of active or inactive placebo, dropouts, evaluation of blinding of intervention, and reporting of expectancy and therapeutic alliance. Results: We included 10 papers reporting on 10 unique trials. The trials generally included populations that were predominantly white and highly educated. The trials had small samples and considerable dropout. Blinding was either unsuccessful or not reported regardless of type of placebo. Few trials published protocols, statistical analysis plans (SAPs), and outcomes relating to psychotherapy fidelity. All trials but one were rated as high risk of bias. Conclusion: Successful blinding of intervention is a significant challenge in this field. To better accommodate this, we suggest that future trials use a parallel-group design and utilize an active placebo on a psychedelic-naïve population. Future trials should publish trial protocol and SAPs, use clinician-rated outcomes accessed by a blinded rater, evaluate blinding of intervention, and consider measuring expectancy and therapeutic fidelity.
Background Evasive personality disorder (AvPD) and social phobia (SP) have substantial costs for patients and their families and great economic costs to the society. While psychotherapy can be an efficacious treatment, many patients drop out during treatment. Increased knowledge on how to decrease dropout from psychotherapy is warranted, including how to increase a patient’s readiness for psychotherapy. Methods We describe a randomized controlled feasibility and superiority trial of 42 individuals with a clinical diagnosis of either SP or AvPD, who are to initiate psychotherapeutic treatment in Danish outpatient mental health services. They will be randomized in a 1:1 ratio to either assessment-as-usual and receive no further assessment or to a Modified Collaborative Assessment (MCA) provided as a pre-treatment intervention before psychotherapy initiation. MCA will include a battery of psychological tests designed to thoroughly assess the patients’ psychopathology. The tests are administered in collaboration with the patient, including detailed oral and written feedback. We hypothesize that the intervention is feasible regarding patient’s acceptance and adherence. We further hypothesize that patients randomized to MCA will reach higher levels of readiness for psychotherapy as assessed with the University of Rhode Island Change Assessment Scale (URICA). Discussion This protocol assesses the feasibility, efficacy, acceptability, and safety of an intervention aimed at changing the readiness for participation in psychotherapy of patients with SP and AvPD. Results from this feasibility study could guide the development of future large-scale trials of MCA and procedures for MCA treatment fidelity assessment. Trial registration NCT2021001.
Background Clinicians usually conduct diagnostic assessments in order to establish a diagnosis or to evaluate the effect of treatment. One meta-analysis suggests that diagnostic assessment administered in collaboration with the patient along with personalized feedback might have a therapeutic effect. Methods We wish to carry out a systematic-review and meta-analysis of the effect on symptomatology when using assessment as a therapeutic intervention for patients with psychiatric illness. We will search in five relevant electronic databases. Two reviewers will independently conduct article selection against pre-defined eligibility criteria, data extraction and quality assessment of included studies. Randomized studies that report on the use of psychological assessment as an intervention will be included in the meta-analysis. We will extract data on symptom-related outcomes, quality of life, dropout and re-diagnoziation and use meta-analysis techniques to compute the effect size of assessmentrelated psychotherapeutic interventions. The review will be conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analysis statement (PRISMA). Risk of bias will be assessed by using the Risk of Bias tool RoB 2.0 of the Cochrane Collaboration. Discussion The results will be able to inform clinicians and policymakers on the effect of assessment, and, depending on the results, could lead to a recommendation for modified assessment procedures and approaches in the mental health services. Ultimately, it might improve the outcome of treatment in the mental health services. Registration Registered in PROSPERO: Registration number CRD42021270567.
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