ArticleEpidemiology and psychiatric sciences2013
A new generation of pragmatic trials of psychosocial interventions is needed.
Article in Epidemiology and psychiatric sciences, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 27 citations in OpenAlex.
- Effectiveness of implementing family involvement on patient outcomes in individuals with psychotic disorders: a pragmatic cluster randomised controlled trial.BMC psychiatry · 2025Trial
- Mind over Matter: Testing the Efficacy of an Online Randomized Controlled Trial to Reduce Distraction from Smartphone Use.International journal of environmental research and public health · 2020Trial
- Evaluation of a positive psychotherapy group intervention for people with psychosis: pilot randomised controlled trial.Epidemiology and psychiatric sciences · 2016Trial
- Feasibility and Effectiveness of a Multi-Element Psychosocial Intervention for First-Episode Psychosis: Results From the Cluster-Randomized Controlled GET UP PIANO Trial in a Catchment Area of 10 Million Inhabitants.Schizophrenia bulletin · 2015Trial
- Challenges to undertaking randomised trials with looked after children in social care settings.Trials · 2015Trial
- Virtual Reality for Patient Education about Hypertension: A Randomized Pilot Study.Journal of cardiovascular development and disease · 2023Article
- Conducting a Pragmatic Trial in Integrated Primary Care: Key Decision Points and Considerations.Journal of clinical psychology in medical settings · 2022Article
- Development of a peer support intervention to improve the experience and outcomes of discharge from inpatient mental health care: the role of experiential knowledge in a coproduced approach.BMC research notes · 2021Article
- Peer support for discharge from inpatient to community mental health services: Study protocol clinical trial (SPIRIT Compliant).Medicine · 2020Article
- An individually tailored behavioral medicine treatment in physical therapy for tension-type headache - two experimental case studies.Journal of pain research · 2016Article
- Developing a change model for peer worker interventions in mental health services: a qualitative research study.Epidemiology and psychiatric sciences · 2015Article
Corrections and comments
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Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This Editorial addresses the crucial issue of which research methodology is most suited for capturing the complexity of psychosocial interventions conducted in 'real world' mental health settings. It first examines conventional randomized controlled trial (RCT) methodology and critically appraises its strengths and weaknesses. It then considers the specificity of mental health care treatments and defines the term 'complex' intervention and its implications for RCT design. The salient features of pragmatic RCTs aimed at generating evidence of psychosocial intervention effectiveness are then described. Subsequently, the conceptualization of pragmatic RCTs, and of their further developments - which we propose to call 'new generation' pragmatic trials - in the broader routine mental health service context, is explored. Helpful tools for planning pragmatic RCTs, such as the CONSORT extension for pragmatic trials, and the PRECIS tool are also examined. We then discuss some practical challenges that are involved in the design and implementation of pragmatic trials based on our own experience in conducting the GET UP PIANO Trial. Lastly, we speculate on the ways in which current ideas on the purpose, scope and ethics of mental health care research may determine further challenges for clinical research and evidence-based practice.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.