Anxiety disorders are very prevalent and often persistent mental disorders, with a considerable rate of treatment resistance which requires regulatory clinical trials of innovative therapeutic interventions. However, an explicit definition of treatment-resistant anxiety disorders (TR-AD) informing such trials is currently lacking. We used a Delphi method-based consensus approach to provide internationally agreed, consistent and clinically useful operational criteria for TR-AD in adults. Following a summary of the current state of knowledge based on international guidelines and an available systematic review, a survey of free-text responses to a 29-item questionnaire on relevant aspects of TR-AD, and an online consensus meeting, a panel of 36 multidisciplinary international experts and stakeholders voted anonymously on written statements in three survey rounds. Consensus was defined as ≥75% of the panel agreeing with a statement. The panel agreed on a set of 14 recommendations for the definition of TR-AD, providing detailed operational criteria for resistance to pharmacological and/or psychotherapeutic treatment, as well as a potential staging model. The panel also evaluated further aspects regarding epidemiological subgroups, comorbidities and biographical factors, the terminology of TR-AD vs. "difficult-to-treat" anxiety disorders, preferences and attitudes of persons with these disorders, and future research directions. This Delphi method-based consensus on operational criteria for TR-AD is expected to serve as a systematic, consistent and practical clinical guideline to aid in designing future mechanistic studies and facilitate clinical trials for regulatory purposes. This effort could ultimately lead to the development of more effective evidence-based stepped-care treatment algorithms for patients with anxiety disorders.
The use of open-label placebos (OLPs) has shown to be effective in clinical trials. We conducted a systematic review and meta-analysis to examine whether OLPs are effective in experimental studies with non-clinical populations. We searched five databases on April 15, 2021. We conducted separate analyses for self-reported and objective outcomes and examined whether the level of suggestiveness of the instructions influenced the efficacy of OLPs. Of the 3573 identified records, 20 studies comprising 1201 participants were included, of which 17 studies were eligible for meta-analysis. The studies investigated the effect of OLPs on well-being, pain, stress, arousal, wound healing, sadness, itchiness, test anxiety, and physiological recovery. We found a significant effect of OLPs for self-reported outcomes (k = 13; standardized mean difference (SMD) = 0.43; 95% CI = 0.28, 0.58; I2 = 7.2%), but not for objective outcomes (k = 8; SMD = - 0.02; 95% CI = - 0.25, 0.21; I2 = 43.6%). The level of suggestiveness of the instructions influenced the efficacy of OLPs for objective outcomes (p = 0.02), but not for self-reported outcomes. The risk of bias was moderate for most studies, and the overall quality of the evidence was rated low to very low. In conclusion, OLPs appear to be effective when examined in experimental studies. However, further research is needed to better understand the mechanisms underlying OLPs.
Arousal , Pain , Humans , Databases, Factual , Sadness , Self Report
INTRODUCTION: Videoconferencing psychotherapy (VCP) delivers treatment to individuals with limited access to face-to-face mental healthcare. VCP's effectiveness has been demonstrated for various disorders and therapeutic interventions. However, there is contradictory evidence regarding the therapeutic alliance in VCP as compared to psychotherapy in person (PIP). This meta-analysis examines whether therapeutic alliance differs by psychotherapy's delivery format, namely VCP versus PIP. METHODS: We searched five databases for trials comparing the therapeutic alliance in VCP and PIP, wherein the therapeutic alliance was rated by either patients or therapists or both. Eighteen publications were included, and the difference between VCP and PIP was assessed. Furthermore, we tested possible moderators of the difference in therapeutic alliance between VCP and PIP by meta-regression, and we assessed the risk of bias of this meta-analysis. RESULTS: The meta-analysis revealed no statistically significant difference in the therapeutic alliance between VCP and PIP for alliance ratings by patients (SMD = -0.09; 95% CI = -0.26; 0.07) as well as by therapists (SMD = 0.04; 95% CI = -0.17; 0.25). No significant moderators were found. DISCUSSION: In this meta-analysis, VCP and PIP did not differ with respect to the therapeutic alliance as rated by either patients or therapists. Further research is required into mechanisms driving the therapeutic alliance in VCP and PIP.
