Development and cross‑national investigation of a model explaining participation in WHO‑recommended and placebo behaviours to prevent COVID‑19 infection

To protect themselves from COVID-19, people follow the recommendations of the authorities, but they also resort to placebos. To stop the virus, it is important to understand the factors underlying both types of preventive behaviour. This study examined whether our model (developed based on the Health Belief Model and the Transactional Model of Stress) can explain participation in WHO-recommended and placebo actions during the pandemic. Model was tested on a sample of 3346 participants from Italy, Japan, Poland, Korea, Sweden, and the US. It was broadly supported: objective risk and cues to action showed both direct and indirect (through perceived threat) associations with preventive behaviours. Moreover, locus of control, decision balance, health anxiety and preventive coping moderated these relationships. Numerous differences were also found between countries. We conclude that beliefs about control over health and perceived benefits of actions are critical to the development of interventions to improve adherence to recommendations

Sub-types of emotion dysregulation in youth with nonsuicidal self-injury: Latent class analysis of a randomized controlled trial

Psychological treatments targeting emotion dysregulation in adolescents are effective in reducing nonsuicidal self-injury (NSSI) but predicting treatment outcome remains difficult. Identifying sub-groups based on repeated measurements of emotion dysregulation pre-treatment may guide personalized treatment recommendations. We used data from a recent trial evaluating internet-delivered emotion regulation therapy for adolescents with NSSI (n = 138). Latent class analysis was used to identify sub-groups based on pre-treatment responses on the 16-item version of the Difficulties in Emotion Regulation Scale. The primary outcome was self-rated NSSI frequency during treatment, and secondary outcome was the proportion of participants with no NSSI 1-month post-treatment. Three sub-groups of emotion dysregulation were identified: Low variability and low mean (Group 1), Low variability and high mean (Group 2), and High variability and low mean (Group 3). Sub-groups did not differ in NSSI frequency during treatment (Group 2 IRR = 1.06 [95% CI 0.49 – 2.29], p = .88; Group 3 IRR = 1.22 [95% CI 0.31 – 4.76], p = .77). However, more participants in Group 1 compared to Group 2 abstained from NSSI at 1-month post-treatment (OR = 3.63 [95% CI 1.16 – 11.33], p = 0.01). Latent class analysis identified sub-groups predictive of NSSI absence post-treatment, demonstrating clinical utility

Sharing clinical notes, and placebo and nocebo effects : Can documentation affect patient health?

This paper connects findings from the field of placebo studies with research into patients' interactions with their clinician's visit notes, housed in their electronic health records. We propose specific hypotheses about how features of clinicians' written notes might trigger mechanisms of placebo and nocebo effects to elicit positive or adverse health effects among patients. Bridging placebo studies with (a) survey data assaying patient and clinician experiences with portals and (b) randomized controlled trials provides preliminary support for our hypotheses. We conclude with actionable proposals for testing our understanding of the health effects of access to visit notes.PACESS (2016-00623

Efficacy of mecobalamin (vitamin B12) in the treatment of long-term pain in women diagnosed with fibromyalgia : protocol for a randomised, placebo-controlled trial

INTRODUCTION: Fibromyalgia causes long-term pain. It affects at least 2% of the population, the majority being women. In addition, extended symptoms corresponding to vitamin B12 deficiency occur. Findings from several studies have indicated that vitamin B12 may be a possible treatment for pain in fibromyalgia. The aim of the proposed study is to evaluate whether vitamin B12 decreases pain sensitivity and the experience of pain (ie, hyperalgesia and allodynia) in women with fibromyalgia. METHODS AND ANALYSIS: The study is a randomised, placebo-controlled, single-blind, clinical trial with two parallel groups which are administered mecobalamin (vitamin B12) or placebo over 12 weeks. 40 Swedish women aged 20-70 years with an earlier recorded diagnosis of fibromyalgia are randomised into the placebo group or the treatment group, each consisting of 20 participants. Outcomes consist of questionnaires measured at baseline and after 12 weeks of treatment. A final re-evaluation will then follow 12 weeks after treatment ends. The primary outcome is tolerance time, maximised to 3 min, which is assessed using the cold pressor test. In order to broaden the understanding of the lived experience of participants, qualitative interviews will be conducted using a phenomenological approach on a lifeworld theoretical basis (reflective lifeworld research approach). ETHICS AND DISSEMINATION: The protocol for the study is approved by the local ethical committee at Linkoping (EPM; 2018/294-31, appendices 2019-00347 and 2020-04482). The principles of the Helsinki Declaration are followed regarding oral and written consent to participate, confidentiality and the possibility to withdraw participation from the study at any time. The results will primarily be communicated through peer-reviewed journals and conferences. TRIAL REGISTRATION NUMBER: NCT05008042