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Background Cognitive behavioural therapy (CBT) is the recommended first-line treatment for children and adolescents with obsessive-compulsive disorder (OCD), but evidence concerning treatment-specific benefits and harms compared with other interventions is limited. Furthermore, high risk-of-bias in most trials prevent firm conclusions regarding the efficacy of CBT. We investigate the benefits and harms of family-based CBT (FCBT) versus family-based psychoeducation and relaxation training (FPRT) in youth with OCD in a trial designed to reduce risk-of-bias. Methods This is an investigator-initiated, independently funded, single-centre, parallel group superiority randomised clinical trial (RCT). Outcome assessors, data managers, statisticians, and conclusion drawers are blinded. From child and adolescent mental health services we include patients aged 8–17 years with a primary OCD diagnosis and an entry score of ≥16 on the Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We exclude patients with comorbid illness contraindicating trial participation; intelligence quotient Discussion In our trial design we aim to reduce risk-of-bias, enhance generalisability, and broaden the outcome measures by: 1) conducting an investigator-initiated, independently funded RCT; 2) blinding investigators; 3) investigating a representative sample of OCD patients; 3) using an active control intervention (FPRT) to tease apart general and specific therapy effects; 4) using equal dosing of interventions and therapist supervision in both intervention groups; 5) having therapists perform both interventions decided by randomisation; 6) rating fidelity of both interventions; 7) assessing a broad range of benefits and harms with repeated measures. The primary study limitations are the risk of missing data and the inability to blind participants and therapists to the intervention. Trial registration ClinicalTrials.gov: NCT03595098, registered July 23, 2018.

To evaluate the possible association between pressure pain sensitivity of the chest bone (PPS) and cardiovascular physiological factors related to persistent stress in connection with a three-month PPS-guided stress-reducing experimental intervention programme.Forty-two office workers with an elevated PPS (≥ 60 arbitrary units) as a sign of increased level of persistent stress, completed a single-blinded cluster randomized controlled trial. The active treatment was a PPS (self-measurement)-guided stress management programme. Primary endpoints: Blood pressure (BP), heart rate (HR) and work of the heart measured as Pressure-Rate-Product (PRP); Secondary endpoints: Other features of the metabolic syndrome.PPS decreased and changes in PPS after the intervention period were significantly associated with HR, PRP, body mass index (BMI) and visceral fat index (all correlation coefficients0.2, p0.05). Compared to the control cluster group, the active cluster group obtained a significant reduction in PPS, Low-density lipoprotein (LDL) cholesterol and total number of elevated risk factors (p0.05). On an individual level, significant and clinically relevant between-group reductions were observed in respect to BP, HR, PRP, total and LDL cholesterol, and total number of elevated risk factors (p0.05).The stress intervention method applied in this study induced a decrease in PPS which was associated with a clinically relevant decrease in resting blood pressure, heart rate, work of the heart and serum cholesterols.

Background: During sports competitions, the performance of athletes may be negatively affected by persistent stress and autonomic nervous system (ANS) dysfunction, both of which can be assessed by pressure pain sensitivity (PPS) at the chest bone. Objectives: To test the association between PPS and sports performance; does a reduction of an elevated PPS improve performance stability and overall performance in Olympic sailors? Methods: The case study included two male athletes during eight months of observation prior to and during Olympic sailing. The daily PPS self-measurements served as feedback guide for persistent stress and ANS dysfunction. Performance stability, overall performance and PPS measure were assessed at three intervals. Results: At baseline, the median PPS was 83, the performance stability was inferior to the mean top 10 competitors, and the overall performance was rank eight. During the observation period, PPS, performance stability and overall performance improved incrementally and significantly. This eventually led the sailors to achieve an Olympic Gold. The PPS, performance stability, and overall performance were all internally closely associated (correlation coefficients: r > 0.70; p < 0.001). Conclusion: The study may suggest a link between persistent stress and ANS dysfunction as assessed by PPS on one side and performance stability and overall performance on the other side.