To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.

This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.

Tertiary care hospitals across metropolitan areas in India.

Adult trauma patients and residents managing these patients were included.

ATLS or PTC training was provided for residents in the intervention arms.

The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.

Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.

Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.

NCT05417243.

Psychosocial stress is a major public health concern, contributing to significant suffering and costs to society. There is a lack of effective interventions that could be offered at an early stage to people who need to reduce their stress in life. Recent advances in psychology have provided evidence-based exercises suitable for testing in an entirely digital intervention. This study aims to estimate the effectiveness of a 12-week digital course in mindfulness- and acceptance-based stress reduction.

The effectiveness of the 12-week digital course will be estimated in a parallel-groups randomised controlled trial, in which the control group will receive referrals to self-studies on mental health information found online. The study population will be individuals 15 or older, seeking help online for stress and who have access to a mobile phone. Employing a Bayesian sequential design, the primary outcome will be monitored monthly, after the 6-month follow-up, to calculate target criteria for when to stop recruiting. Perceived stress (Cohen’s 10-item version) will be the primary outcome, with estimands of interest being differences between groups at 3 (immediate), 6 (prolonged) and 12 months (maintained). Mediation analysis will reveal if differences between groups are mediated by acquired equanimity. Effectiveness will be analysed with Bayesian regression models, and mediation will be analysed by using a causal inference framework.

The research was approved by the Swedish Ethical Review Authority on 2024-05-07 (2024-01974-01). The study will reach out to a vulnerable population, and participation may displace efforts to seek professional help. We have built-in automatic advice to seek additional help for participants scoring high on the depression scale at baseline, before allocation to study groups. The findings from this study will be submitted to peer-reviewed journals and presented at relevant national and international meetings.

ISRCTN39222610.