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Emotion regulation-based internet-delivered cognitive behavioural therapy for premenstrual dysphoric disorder: study protocol for a randomised controlled trial in Sweden
Published 2025-01-01“…The current study aims to evaluate the effects and cost-effectiveness of an internet-delivered CBT (ICBT) intervention for PMDD incorporating skills training in emotion regulation and interpersonal effectiveness.Methods and analysis The study is a parallel two-group randomised controlled trial with 1:1 allocation to 8 weeks of therapist-guided ICBT or a waitlist control condition. …”
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Contamination and washing of cloth masks and risk of infection among hospital health workers in Vietnam: a post hoc analysis of a randomised controlled trial
Published 2020-09-01“…Background In a previous randomised controlled trial (RCT) in hospital healthcare workers (HCWs), cloth masks resulted in a higher risk of respiratory infections compared with medical masks. …”
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Blended digital health intervention for adolescents at high risk with digital media use disorders: protocol for a randomised controlled trial within the Res@t-Consortium
Published 2025-01-01“…The efficacy of the app will be evaluated in a randomised controlled trial with a waitlist control group. The primary outcome is the reduction of DMUD symptoms over a 20-week period following the onset of app training. …”
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Persistence of gastrointestinal symptoms in irritable bowel syndrome and ulcerative colitis: study protocol for a three-arm randomised controlled trial (SOMA.GUT-RCT)
Published 2022-06-01“…Our primary hypothesis is that persistent gastrointestinal symptoms in UC and IBS can be improved by modifying dysfunctional symptom expectations and illness-related anxiety using expectation management strategies.Methods and analysis To assess the extent to which persistent somatic symptoms are modifiable in adult patients with UC and IBS, we will conduct an observer-blinded, three-arm randomised controlled trial. A total of 117 patients with UC and 117 patients with IBS will be randomised into three groups of equal size: targeted expectation management aiming to reduce illness-related anxiety and dysfunctional symptom expectations in addition to standard care (SC, intervention 1), non-specific supportive treatment in addition to SC (intervention 2) or SC only (control). …”
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Smart phone-based transcutaneous electrical acupoint stimulation as adjunctive therapy for hypertension (STAT-H trial): protocol for a cluster randomised controlled trial
Published 2022-07-01“…The aim of this study is to evaluate the effectiveness and safety of the smart phone-based TEAS as adjunctive therapy for hypertension.Methods and analysis This study is a 52-week cluster randomised controlled trial with 1600 hypertension patients in 32 community health service centres. …”
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Economic and relationship-strengthening intervention to reduce alcohol use in couples living with HIV in Malawi: a study protocol for a randomised controlled trial of Mlambe
Published 2025-02-01“…We will conduct a full-scale, randomised controlled trial (RCT) to evaluate the efficacy and cost-effectiveness of Mlambe.Methods and analysis We will enrol 250 adult married couples having at least one partner living with HIV and reporting heavy alcohol use. …”
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Remote symptom monitoring with patient-reported outcomes and nudges during lung cancer immunotherapy in China (PRO-NET): protocol for a randomised controlled trial
Published 2025-01-01“…Secondary objectives include assessing the effect of PRO-symptom monitoring on survival, physical function, symptom control, mental health, cost-effectiveness and implementation fidelity.Methods and analysis The PRO-NET study is a two-arm, parallel randomised controlled trial. The study will enrol at least 300 advanced NSCLC patients undergoing immunotherapy in China. …”
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IMPACT-ICU feasibility study: pragmatic mixed-methods randomised controlled trial of a follow-up care intervention for survivors of critical illness and caregivers
Published 2025-01-01“…This study will assess the feasibility of a randomised controlled trial (RCT) evaluating an intensive care unit (ICU) follow-up care bundle versus standard-of-care for ICU patients and their caregivers.Methods and analysis This is a single-centre feasibility study. …”
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Safe, effective and cost-effective oxygen saturation targets for children and adolescents with respiratory distress: protocol for a randomised controlled trial (OxyKids study)
Published 2024-12-01“…This trial aims to test the hypothesis that a lower SpO2 threshold of 88% safely reduces the length of hospital stay in children admitted with respiratory distress when compared with a 92% SpO2 threshold and to assess its cost-effectiveness.Methods and analysis This is a multicentre, open-label, randomised controlled trial with two parallel arms. A total of 560 children aged 6 weeks to 12 years admitted with a diagnosis of bronchiolitis, viral wheeze or lower respiratory tract infection will be recruited and equally randomised into an intervention or usual care arm. …”
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DepRescribing inapprOpriate Proton Pump InhibiTors (DROPIT): study protocol of a cluster-randomised controlled trial in Swiss primary care
Published 2025-01-01“…This protocol describes a study to evaluate the effectiveness of a PPI deprescribing intervention in comparison to usual care in the Swiss primary care setting.Design An open-label, cluster randomised controlled trial.Setting Swiss primary care settings.Participants Included participants will be adults with inappropriate PPI treatment and will be recruited by general practitioners (GPs). …”
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Protocol for a mixed-methods randomised controlled trial evaluating the psychosocial effects of an expressive arts-based intervention on adults with age-related macular degeneration
Published 2024-12-01“…Given the limited studies addressing the psychosocial needs of adults with AMD and, in particular, using an expressive arts-based intervention (EXABI) as an intervention, this study aims to investigate the effectiveness of such an intervention in enhancing the psychosocial well-being of adults with AMD.Methods and analysis This study will employ a mixed-methods randomised controlled trial design. One hundred fifty-four participants with AMD will be recruited and randomised into either the EXABI or treatment-as-usual waitlist control group. …”
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Effects of manual osteopathic interventions on psychometric and psychophysiological indicators of anxiety, depression and stress in adults: a systematic review and meta-analysis of randomised controlled trials
Published 2025-02-01“…Objectives To evaluate whether osteopathic and related manual interventions improve adult mental health (depression, anxiety, stress) and psychophysiological measures (eg, heart rate variability, skin conductance).Design Systematic review and meta-analysis of randomised controlled trials (RCTs).Data sources PubMed, MEDLINE (Ovid), Scopus, Cochrane, and AMED, searched through September 2024.Eligibility criteria English-language RCTs with ≥30 participants investigating osteopathic or related manual therapies (eg, myofascial release, high-velocity low-amplitude thrusts) delivered by qualified practitioners, compared with no treatment or sham, and reporting immediate postintervention mental health or psychophysiological outcomes.Data extraction and synthesis Full-text screening, risk-of-bias assessment and data extraction were conducted independently by multiple reviewers using a standardised Joanna Briggs Institute (JBI) Extraction Form. …”
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