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?

<p>A clear idea of the intervention's potential pathways to produce expected effects (B)</p> Signup and view all the answers

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

<p>The Theory of Planned Behaviour (A)</p> Signup and view all the answers

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

<p>Short follow-up times (C)</p> Signup and view all the answers

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

<p>Highly regulated and monitored trials of medicinal products (B)</p> Signup and view all the answers

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

<p>Publication bias (C)</p> Signup and view all the answers

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

<p>Complexity of psychosocial treatments (D)</p> Signup and view all the answers

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

<p>Standardization as a research paradigm (A)</p> Signup and view all the answers

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

<p>To provide a fair comparison unaffected by initial differences between groups (B)</p> Signup and view all the answers

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

<p>Gathering anecdotal evidence from service leaders (B)</p> Signup and view all the answers

What is a significant limitation of conducting Randomized Controlled Trials?

<p>They can be a slow process that takes over 15 years to yield definitive evidence (A)</p> Signup and view all the answers

Which component is essential for achieving objectivity in RCTs?

<p>Involving independent observers who are blind to participant groups (C)</p> Signup and view all the answers

What factor can potentially influence the outcomes of a trial?

<p>Contextual factors relevant to the trial setting (D)</p> Signup and view all the answers

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

<p>Identical treatment of groups except for intervention (A)</p> Signup and view all the answers

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

<p>Obtain informed consent from all participants (C)</p> 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?

<p>Intention-to-treat analysis (B)</p> Signup and view all the answers

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

<p>Long-term follow-up (A)</p> Signup and view all the answers

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

<p>Safety monitoring committee (D)</p> Signup and view all the answers

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

<p>A detailed data management plan (C)</p> Signup and view all the answers

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

<p>Conducting multi-center trials (A)</p> Signup and view all the answers

What is a consideration when including economic evaluation in research?

<p>It should be included alongside clinical outcomes when appropriate (A)</p> Signup and view all the answers

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

<p>Health gain related to expenditure (C)</p> Signup and view all the answers

What does the term QALY stand for in health economics?

<p>Quality Adjusted Life Year (A)</p> Signup and view all the answers

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

<p>Qualitative research (B)</p> Signup and view all the answers

How do qualitative research methods contribute to understanding interventions?

<p>By exploring mechanisms and why interventions may fail (D)</p> Signup and view all the answers

What is a key characteristic of mixed methods in research?

<p>Combining both qualitative and quantitative methods (B)</p> Signup and view all the answers

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

<p>They ensure a fair comparison of treatment effects (C)</p> Signup and view all the answers

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

<p>The balance between intervention costs and financial benefits (C)</p> Signup and view all the answers

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

<p>RCTs require extensive co-production efforts which may not be feasible (C)</p> Signup and view all the answers

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

<p>Development and evaluation of complex interventions (A)</p> Signup and view all the answers

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

<p>Co-production and co-design among stakeholders (A)</p> Signup and view all the answers

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

<p>The clinical problem the intervention addresses (C)</p> Signup and view all the answers

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

<p>Who will deliver the intervention to whom? (B)</p> Signup and view all the answers

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

<p>Government regulations (A)</p> Signup and view all the answers

What does the framework suggest regarding existing evidence for interventions?

<p>Existing evidence should guide the development process. (B)</p> Signup and view all the answers

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

<p>By offering insights on what may be acceptable and workable (D)</p> Signup and view all the answers

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

<p>A justification for why the intervention will succeed (A)</p> Signup and view all the answers

Flashcards

Randomized Controlled Trial (RCT)

A research method that compares two groups, one receiving the intervention and one not, to see if the intervention has a real effect.

Pathway for Developing Psychosocial Interventions

A systematic approach for developing and testing mental health interventions using a series of steps, starting with research and ending with implementation.

Feasibility Study

A study that tests the feasibility and acceptability of a new intervention before conducting a full-blown trial.

Implementation Study

A study that examines how well a fully developed intervention works in a real-world setting, after it has been tested in a randomized controlled trial.

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Slow Process of Intervention Development

The process of carefully developing and testing new interventions can be very time-consuming, sometimes taking 15 years or more to gather definitive evidence.

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Cost-effectiveness

Measures how much health improvement is achieved compared to the cost of achieving it. For example, cost per Quality Adjusted Life Year (QALY) gained.

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Qualitative Research

A type of research that uses words and text to explore people's experiences, opinions, and perspectives. It helps understand individual needs and preferences.

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Mixed Methods

A research design that combines both quantitative and qualitative methods. This helps provide a more comprehensive understanding of an intervention's effectiveness and how it works in real-world settings.

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Naturalistic Studies

Research that focuses on studying interventions in real-world settings, without controlled experimental conditions. This helps understand how interventions work in practice.

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Quasi-experiments

Research methods that are not fully controlled experiments, but still try to establish a cause-and-effect relationship. Often used when random assignment is not feasible.

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Big Data

The use of large datasets to analyze patterns and trends in health data. This can be used to understand health outcomes and develop more efficient interventions.

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Co-production

The process of involving service users in the design, delivery, and evaluation of interventions. This helps ensure interventions are relevant to people's needs and preferences.

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Identical Treatment of Groups

Equal treatment of groups except for the intervention being studied, ensuring any differences observed are likely due to the intervention.

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Blinding

Participants, researchers, and those assessing outcomes are unaware of who receives the intervention. Helps prevent bias in measurement.

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Intention-to-Treat Analysis

Analyzing all participants based on their original group assignment, even if they drop out or change treatment. Provides a more realistic picture of the intervention's effect.

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A Priori Hypothesis

Focusing on the specific hypothesis stated before the study begins. Helps prevent finding patterns in data that weren't planned for.

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Informed Consent

Ensuring participants understand the risks and benefits of the study before they decide to participate. It's ethical and protects participants.

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Ethical Approval

Having an independent group review the research plan to ensure it ethically respects participants and scientific integrity.

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Adverse Event Reporting

Systematically tracking and reporting any negative effects of the intervention on study participants. Helps ensure safety and transparency.

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Long-term Follow-up

Following up with study participants after the intervention ends to see if the effects last over time. Important for understanding long-term effects.

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Program Theory

An expected causal link between an intervention and its intended outcomes, outlining how the intervention is supposed to work.

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Refinement of Program Theory

A process where the intervention is refined and adapted based on feedback, data, and experiences gathered throughout the research.

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Existing Frameworks in Program Theory

The use of pre-existing frameworks in psychology or sociology to explain the mechanisms behind an intervention's impact.

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Practical Ideas in Program Theory

Incorporating practical, often informal ideas about how an intervention might achieve its goal.

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Importance of Program Theory

A critical requirement for research is to start with a clear understanding of how an intervention is expected to work.

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Co-production/Co-design

An important aspect of intervention development that involves actively integrating the perspectives of those involved, such as service users, clinicians, and researchers.

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MRC/NIHR Framework for Developing and Evaluating Interventions

A framework that guides the development and evaluation of complex interventions, highlighting the importance of understanding the intervention's content, delivery, and context.

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Publication Bias

The tendency for studies with positive results to be more likely to be published, creating a biased view of the evidence. This can lead to an overestimation of the effectiveness of treatments.

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Mixed Methods Research

A research design that combines qualitative and quantitative methods. This helps provide a more comprehensive understanding of an intervention's effectiveness and how it works in real-world settings.

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Complex Psychosocial Treatments

Complex interventions that involve a combination of different components beyond just a therapist and patient. Examples include crisis care, support groups, and skills training. These interventions are difficult to study due to their complexity.

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CTIMPs (Clinical Trials of Medicinal Products)

Clinical Trials of Medicinal Products are highly regulated and monitored to ensure scientific rigor and the safety of participants. They follow strict guidelines and ethical standards.

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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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Related Documents

Session 8: Developing and Evaluating Interventions PDF

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.

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