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.

IntroductionIt is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I.Methods and analysisIn this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model.Ethics and disseminationThe study protocol was approved by the Ethics Committee of the Medical Centre—University of Freiburg. The results of the study will be published irrespective of the outcome.Trial registration numberDRKS00021503.

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.

Background: The use of open-label placebos (OLPs) has been 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. Methods: We searched five electronic 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 effectiveness of OLPs. Results: Of 3,573 identified records, 20 studies comprising 1,201 participants were included. We found a significant effect of OLPs for self-reported outcomes (SMD=0.43; 95% CI=0.28, 0.58; I2=7.2%) but not for objective outcomes (SMD=-0.02; 95% CI=-0.25, 0.21; I2=43.6%). The level of suggestiveness of the instructions influenced the effectiveness of OLPs for objective outcomes (p=.02), but not for self-reported outcomes. Discussion: OLPs appear to be effective when examined in experimental studies. However, the small number of studies highlights the need for further research.