Clinical Mental Health Investigating Studies PDF

**[Clinical Mental Health]** **[Investigating Studies]** [Basic Principles of RCT:] [Evidence-Based Health Care:] - Evidence-based medicine -- a revolt against tradition and unsupported clinical intuition - Establishes a hierarchy of evidence: - Systematic Reviews - Random...

**[Clinical Mental Health]** **[Investigating Studies]** [Basic Principles of RCT:] [Evidence-Based Health Care:] - Evidence-based medicine -- a revolt against tradition and unsupported clinical intuition - Establishes a hierarchy of evidence: - Systematic Reviews - Randomised Controlled Trials - Other Controlled/Cohort Designs - 1980s: case study gives way to RCT - RCTs prioritised by funders, reviewers and guideline developers as the gold standard for research [How are interventions developed:] Main questions that should be addressed in developing an intervention for a study - What clinical problem is the intervention meant to address? Is there a demonstrable unmet need and what is the relevant population? - What evidence is already available? Are there interventions that could be used/adapted? - What are the views of the relevant stakeholders (service users, carers, clinicians, researchers, experts) on what may be acceptable and workable and fits their priorities? Increasing emphasis on co-production, involvement (not just consultation) at every stage - What is the programme theory underpinning the intervention? Can you describe how and why it's supposed to achieve change? - What is the exact content of the intervention, who will deliver it to whom and in what context? [The point of RCTs:] - Fair comparison, not affected by initial differences between groups - Everything possible to achieve objectivity -- replicable measures, independent observers and analysts who do not know what group participants are in - Ammunition to argue for innovations that really work (CBT for psychosis) against ones that don't [RCTs in the pathway for developing and testing psychosocial interventions:] - Recommended pathway for developing and testing interventions: - Develop theoretical framework - Assemble relevant evidence - Look for elements to adapt or incorporate - Model components of intervention - Test Feasibility & Acceptability - Full pilot of intervention and trial proceedings - Definitive RCT - Implementation Study - But in practice, new interventions often developed by enthusiastic service leaders [Programme Theories:] *Interventions should be theory-driven, in the sense that they are based on a **programme theory** which articulates the intended causal link between an intervention and its outcomes* - Consensus is that there should be a clear programme theory underpinning any intervention tested in research (though this varies in practice) - Ideally programme theory should be developed at the outset, refined in the light of subsequent findings and experiences - Programme theories may incorporate existing psychological or sociological frameworks (e.g. the Theory of Planned Behaviour) - They often also include more practical *ad hoc* ideas about the pathways by which an intervention may achieve an effect, incorporating previous research and stakeholder input - Basic requirement: to start an investigation with a clear idea of the potential pathway by which an intervention is hypothesised to produce its expected effect. [Theories of Behaviour Change:] - Theories of behaviour change are among the most frequently used pre-existing theoretical frameworks in intervention development - Seen as central to many health interventions -- many grant applications/major studies include a relevant expert, often health psychologist - Intervention development often involves adapting/applying well-established theoretical frameworks to a specific study context along with evidence about pathways, stakeholder views - Result: a study-specific theory of change or logic model [Limitations of Trials:] - Slow process -- 15 years + to definitive evidence - Contextual factors can affect outcome e.g., the content of treatment as usual - Tricky for interventions delivered to whole services or whole areas - Do not tend to prioritise service user experience or preference [What's the place of RCTs in current mental health research? Drugs:] - RCT is main paradigm -- would you want to take a new drug without one? - High proportion in industry -- issues of partial disclosure & short follow-up times, selection of unfavourable controls that make new therapy look more successful - Trials of medicinal products - highly regulated and monitored as CTIMPs (Clinical Trials of Medicinal Products -- some digital tools included in this) - Publication biases the greatest hazard -- commentaries on excess of positive published results [What's the place of RCT's in current mental health research? Psychological Treatment:] - RCT's standard for CBT and 3^rd^ wave psychological treatments - Manualising interventions - Therapists trained to right level - Monitoring of delivery fidelity -- often by taping sessions - Assessment of cost-effectiveness usually included [What's the place of RCTs in current mental health research? Complex psychosocial interventions:] - Many RCTs of complex interventions with components beyond a therapist/patient interaction (e.g. crisis care, supported employment, early intervention) - Quality improved by multicentre design, co-production, theory development, thorough feasibility & pilot studies, manualisation, rigorous conduct overseen by CTUs, fidelity measurement. - Challenges: - Many local factors relating to participating individuals, & organisational & cultural context affect content & impact, of both experimental and control interventions. - Individual randomisation may be challenging e.g. where an intervention affects practice of a team or organisation. - Implementing interventions fully and consistently is often challenging, the more so where they are complex team-level interventions. - Still an aspiration to do a randomised trial of a novel intervention if you can [Cluster Randomised Trials:] - Randomise at a level higher than individual -- e.g., staff or team caseloads areas - Useful in some circumstances where its hard to randomise individuals - Challenges: - Having enough clusters for randomisation to produce similar groups - Bigger overall numbers are needed - Logistics, especially of assessment pre-randomisation - New variants e.g., stepped wedge designs [Quasi-Experiments & Naturalistic Studies:] - Quasi-Experiments: Non-Randomised Comparative study - Pre-post comparison - Area by area, or service by service comparison - Naturalistic Studies: - Investigate research questions that can be addressed without changing the care people receive [Observational research on drugs:] - Observational designs used to compare patterns of adherence and discontinuations, outcomes, side effects between drugs - Some of the most successful studies based on routine data address questions in psychopharmacology Advantages: - Longer follow-up than most RCT's - Unselected samples -- estimated \