Investigating Treatments in Mental Health

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Questions and Answers

What is the primary purpose of having a clear programme theory in an intervention?

To eliminate the need for stakeholder involvement

To limit the scope of research findings

To ensure the intervention is based on anecdotal evidence

To establish an intended causal link between the intervention and its outcomes (correct)

At what stage should a programme theory ideally be developed?

During the data collection phase

When analyzing intervention outcomes

At the outset of the research (correct)

After the initial intervention is implemented

Which approach is NOT primarily associated with developing programme theories for interventions?

Incorporating existing psychological frameworks

Relying solely on expert opinions (correct)

Including stakeholder input

Refining the theory based on findings and experiences

What basic requirement should be met before starting an investigation into an intervention?

A clear idea of the intervention's potential pathways to produce expected effects Signup and view all the answers

Which framework can be utilized to enhance programme theories in interventions?

The Theory of Planned Behaviour Signup and view all the answers

What is a significant issue that arises in Randomized Controlled Trials (RCTs) within the pharmaceutical industry?

Short follow-up times Signup and view all the answers

What are Clinical Trials of Medicinal Products (CTIMPs) primarily focused on?

Highly regulated and monitored trials of medicinal products Signup and view all the answers

What is considered the greatest hazard in the publication of clinical trial results?

Publication bias Signup and view all the answers

Why is there more suspicion regarding RCT methodology in areas beyond standard therapies?

Complexity of psychosocial treatments Signup and view all the answers

What aspect of RCTs is particularly emphasized for Cognitive Behavioral Therapy (CBT) and similar treatments?

Standardization as a research paradigm Signup and view all the answers

What is the primary objective of Randomized Controlled Trials (RCTs)?

To provide a fair comparison unaffected by initial differences between groups Signup and view all the answers

Which of the following is NOT part of the recommended pathway for developing and testing interventions?

Gathering anecdotal evidence from service leaders Signup and view all the answers

What is a significant limitation of conducting Randomized Controlled Trials?

They can be a slow process that takes over 15 years to yield definitive evidence Signup and view all the answers

Which component is essential for achieving objectivity in RCTs?

Involving independent observers who are blind to participant groups Signup and view all the answers

What factor can potentially influence the outcomes of a trial?

Contextual factors relevant to the trial setting Signup and view all the answers

What is a crucial method to limit bias in randomized controlled trials?

Identical treatment of groups except for intervention Signup and view all the answers

Which factor is essential for ensuring the ethical conduct of a study?

Obtain informed consent from all participants Signup and view all the answers

What type of analysis aims to include all randomized participants in the groups to which they were assigned, regardless of whether they completed the treatment?

Intention-to-treat analysis Signup and view all the answers

Which analysis is advised to assess the durability of effects in a study?

Long-term follow-up Signup and view all the answers

What should researchers establish to monitor and manage adverse effects during a trial?

Safety monitoring committee Signup and view all the answers

In the context of data management for RCTs, which plan should be developed?

A detailed data management plan Signup and view all the answers

Which aspect is important to enhance the external validity of a trial's results?

Conducting multi-center trials Signup and view all the answers

What is a consideration when including economic evaluation in research?

It should be included alongside clinical outcomes when appropriate Signup and view all the answers

What is the primary focus of cost-effectiveness in mental health innovations?

Health gain related to expenditure Signup and view all the answers

What does the term QALY stand for in health economics?

Quality Adjusted Life Year Signup and view all the answers

Which research method explores individual experiences, preferences, and needs of service users?

Qualitative research Signup and view all the answers

How do qualitative research methods contribute to understanding interventions?

By exploring mechanisms and why interventions may fail Signup and view all the answers

What is a key characteristic of mixed methods in research?

Combining both qualitative and quantitative methods Signup and view all the answers

What is the main benefit of using Randomized Controlled Trials (RCTs) in testing new treatments?

They ensure a fair comparison of treatment effects Signup and view all the answers

In health economics, what does a cost-benefit analysis evaluate?

The balance between intervention costs and financial benefits Signup and view all the answers

What is one reason some studies might use quasi-experiments over RCTs?

RCTs require extensive co-production efforts which may not be feasible Signup and view all the answers

What is the primary focus of the MRC/NIHR framework for developing interventions?

Development and evaluation of complex interventions Signup and view all the answers

Which aspect is emphasized in the development of interventions as per the framework?

Co-production and co-design among stakeholders Signup and view all the answers

What should be considered first when developing an intervention for a study?

The clinical problem the intervention addresses Signup and view all the answers

In understanding the context of an intervention, which question should be prioritized?

Who will deliver the intervention to whom? Signup and view all the answers

What perspective is NOT typically considered when evaluating interventions according to the framework?

Government regulations Signup and view all the answers

What does the framework suggest regarding existing evidence for interventions?

Existing evidence should guide the development process. Signup and view all the answers

How do stakeholders contribute to the intervention development process as emphasized in the framework?

By offering insights on what may be acceptable and workable Signup and view all the answers

Which of the following is a key element of the 'programme theory' within the intervention framework?

A justification for why the intervention will succeed Signup and view all the answers

Study Notes

Developing and Evaluating Interventions (Workshop)

Lead teachers: Sonia Johnson, Becky Appleton, Bryn Lloyd-Evans, Maev Conneely
Topics covered: Theory of Behaviour Change, How Interventions are Developed, Methods of Evaluation, including RCTs.
Reading list: PSBS0002: Core Principles of Mental Health Research, University College London (talis.com).

Preliminary Lectures - Investigating Treatments in Mental Health

Basic Principles of RCTs:
- RCTs involve a process of Randomisation, allocating participants to either Treatment A or Treatment B.
- Both groups are monitored and assessed for the outcomes of the intervention, then compared.
- The goal is a fair evaluation unaffected by participant characteristics.
- Key elements in RCTs include:
  - Sample population: The group of individuals targeted for the study.
  - Randomisation: Allocating participants to groups using a random procedure.
  - Treatment A, Treatment B: Different experimental conditions.
  - Outcomes: The results measured to identify the effect of each treatment.

Evidence before RCTs

Expert opinion
Clinical Judgement
Case series
Hierarchy and Power

Evidence-Based Health Care

Evidence-based Practice - arose in opposition to standard practice.
Hierarchy of evidence:
- Systematic reviews (generally of RCTs)
- Randomised Controlled Trials (RCTs)
- Other controlled studies/cohort designs
RCTs prioritised in research due to being the gold standard.

The Point of RCTs

Fair comparison, not affected by initial participant differences.
Objective evaluation using replicable measures.
Arguing for innovations that work (e.g., CBT) versus those that don't (Community Treatment Orders).
Pathway for developing/testing psychosocial interventions.

Stages of Development and Evaluation of Complex Interventions:

NIHR/MRC framework
Limitations of Trials:
- Time-consuming process (15+ years for definitive evidence)
- Contextual factors strongly affect outcomes e.g. "treatment as usual."
- Difficulties in delivering intervention to whole services.

Quasi-Experiments and Naturalistic Studies

Quasi-experiments: Non-randomised comparative studies.
Types: Pre-post comparison, area/service comparison, cohort study.
Examples: TIPS Study

Classical Quasi-Experimental Design

Diagram depicting pre-intervention, intervention, and post-intervention data collection.

Naturalistic Studies

Research questions addressed without changing the care people receive.

Current thinking about quasi-experiments

Previously considered biased, now gaining a more neutral perspective.
Modern statistical methods improve quality.
Routine data (especially "big data") are gaining popularity.
Routine data includes national monitoring data (e.g., NHS Digital data on admissions).

The Rise of "Big Data"

National monitoring data e.g. NHS Digital data.
Anonymised extracts from patient records.

The Role of Health Economists

Cost-effectiveness: relating health gain to cost expenditure
QALYs (Quality Adjusted Life Years): outcome measure, expenditure per QALY.

Understanding individual views and experiences: Qualitative Research

Service users' perspectives in RCTs are frequently overlooked.
Qualitative research explores words/text, rather than numbers.
Methods: interviews, focus groups, diaries, observation.
Interventions often co-produced with service users.

Key Points for Validity

Representative sample of target population
Adequate sample size
Effective concealment of randomization
Identical treatment of groups (except intervention)
Blinding of patients, investigators, and outcome assessors
Intention-to-treat analysis

Additional Considerations

Ethical considerations (informed consent, IRB approval).
Data management and analysis (detailed plan, appropriate methods, interim evaluations.)
Adverse event reporting (safety monitoring committee).
Long-term follow-up (consideration of effects' durability).

Key: Designing a Research Project: Randomised Controlled Trials and Their Principles

RCTs considered the gold standard for cause-effect relationships between interventions and outcomes.
Random assignment of participants to experimental and control groups.
Intervention applied to the experimental group only.
Comparison of outcomes between groups.
Minimizing Errors: Bias (selection, observer/information), confounding, chance.
Strategies to reduce errors: large sample sizes

Protocol Development

Specific, a priori hypothesis (e.g., drug A more effective than drug B).
Literature review.
Define study design elements:
- Population sampling.
- Randomisation method.
- Intervention application.
- Outcome measures (analysis plan).

Randomization

Importance of equally distributing confounding variables.
Random allocation for fair comparison.
- Computer-generated random allocations.
- Sealed, opaque, numbered envelopes.
- Remote randomization facility.
Advanced techniques:
- Blocked randomization.
- Stratified randomization.

Baseline Measurements

Demographic information and prognostic factors are collected.
Equal distribution of variables between groups should be demonstrated.

Conducting the Trial

Apply intervention to the experimental group.
Measure pre-defined outcomes.
Implement quality control measures.

Reporting

Follow CONSORT guidelines for reporting RCTs.
Include population sampling methods, randomization process, baseline characteristics.

Cluster Randomized Trials

Randomization at a higher level (e.g., staff, teams, areas).
Useful in scenarios where individual randomization isn't feasible or practical.

Summary

RCT remains the gold standard for intervention testing.
RCTs are often resource-intensive and time-consuming.
Quasi-experiments and naturalistic studies are valuable options for rapid data collection.
Other forms of data including "big data" are increasingly important in research.

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Description

This workshop focuses on developing and evaluating mental health interventions, including the theory of behaviour change and methods of evaluation. Participants will learn about the principles of Randomised Controlled Trials (RCTs) and their applications in assessing treatment outcomes. Join us to deepen your understanding of intervention strategies and their effectiveness.