RCTs in psychotherapy Flashcards
Introduce the role of RCTs in psychotherapy outcomes research
- Randomised control trials (RCTs) are currently deemed the gold-standard research for producing evidence
- Sitting just below the systemic review and meta-analysis/synthesis in the hierachy of evidence
- Outcome data from RCTs is utilised by NICE to determine which psychotherapies are recommended
- RCTs are not without criticism
- This essay will discuss some of the advantages and disadvantages when applied to psychotherapy outcome research, and how research can be more inclusive for the best interests of the patients
Why is it important to clarify EBT and EBP?
- Important to clarify evidence-based treatment and evidence-based practice as they are innappriopriately used interchangably, introducing confusion into their discussion
- EBTs are interventions that have produced therapeutic change in controlled trials
- EBP is clinical practice that is influenced by evidence, clinical expertise, and patient considerations (Kazdin, 2018)
What study designs are utilised in evidence-based treatment?
- It is a misconception that EBT is only produced by RCTs
- Whilst the gold standard, other control studies include non-randomised study designs such as cohort studies and case-control studies
- Both of which can be used in quantitiative and qualitative analysis
Discuss the role of meta-synthesis in the hierarch of evidence
- Each study design has its benefits and weaknesses and should be evaluated accordingly
- Murad et al (2016) propose a modified hierarchy of evidance to account for this
- Example, poorly rated RCTs are less robust that highly rated cohort studies
- The top of the hierarchy consists of systematic reviews anda meta-analyses
- Qualitative data can be similarly meta-synthesised, producing a higher hierarchal position than RCTs
Outline RCT study design
- Random allocation of individuals within the sample to one of at least two groups
- Large sample to ensure randomisation equally distributes a variety of known and unknown confounders
- One group is given the treatment/intervention of choice
- Other is typically a wait-list control (WLC) or treatment as usual (TAU)
- This design allows findings of causation, as any differentiating results should be due to intervention
Discuss the challenges RCTs face in psychotherapy research
- Whilst RCTs have greatly enhanced knowledge in areas such as drug effect, its implementation in psychotherapy research is contested
- It is difficult if not impossible to blind therapists
- Certain factors exist only in psychotherapy, such as allegiance bias
- Aetiology and explanatory models continue to be debated for many mental illnesses
- Complex psychosocial interactions means that specfic factors which bring about change are harder to isolate or control (Burgess, 2018)
What is the major problem with RCTs from a clinical standpoint
- Central concern for use of RCTs is the potential lack of generalisable findings
- Two studies will be used to demonstrate this
- Watson et al (2003): allegiance-balanced RCT comparing CBT and process-experiential therapy (PET) in the treatment of derpession
- Fonagy et al (2015): RCT comparing long-term psychoanalytic psychotherapy (LTPP) plus (TAU) vs TAU alone for treatment-resistant depression
Outline the criticisms of RCTs
- Generalisability of RCT
- Therapist factors
- Patient factors
- Technique factors
- Methodology
- Randomisation
- Outcome measures
- Statistical power
Discuss how therapist factors impact the generalisability of RCT
- Therapist factors include interpersonal skills, training, experience, and allegiance bias
- Watson et al (2013) used counselling masters/doctorate students from a single univeristy and a couple of psychologists
- All adhered to either CBT or PET
- Received equal training as per treatment manuals, from respective experts
- Average experience just over 5 years
- Can be argues that use of a single university limits generalisability to other training backgrounds
- Fonagy et al (2015) used therapists qualified with the British Psychoanalytic Council
- Average experience of 17 years
- LTPP is not explicitely recommended in NICE guidelines for depression
- Potential for negative allegiance bias towards TAU only group
Discuss how patient factors impact the generalisability of RCTs
- Patient factors include demographic, social factors, individual depression presentation, and prior treatment
- Currently these do not appear to consistently predict treatment outcomes, except fro chronicity and severity of depression (NICE, 2018)
- Practice-based individualised evidence is best to identify the releveant factors in each patient
- This evidence will best inform personal care plans
Discuss concerns over representative samples in RCTs
- Common concern is that study samples are not representative of clinical patients
- Suicidality and intellectual disability are often excluded from depression studies, but this is not invariably true (Kazdin, 2008)
- Important to remember research is also dictated by practicality, public interest, ethics approval, and cost-effectiveness
- Empirical testing has shown that severity, complexity, and comborbidity do not impede the therapeutic change in EBT (Kazdin, 2008)
- It will always be possible to state “my patients are worse, different, more complex”, and no amount of studies will absolutely resolve this (Kazdin, 2008)
What is the problem with criticisng the generalisability of RCTs?
- Criticisms over generalisability based on therapist and patient factors is a double-edged sword (Kazdin, 2008)
- This very same argument can be placed on clinical practice
- The uniqueness of patients creates non-generalisable results from both research and prior clinical experience
- Clinical judgement has not fared well over decades of evaluation (Kazdin, 2008)
How do technique factors impact generalisability of RCTs?
- RCTs often utilise a more-structured approach to assessment and intervention compared to clinical practice
- Fonagy et al (2015) prohibite the use of short-term psychotherapy, normally featured in the guidelines
Critique how outcomes are measures in psychotherapy RCTs
- Results are reported in terms of statistical significance and clinical significance
- Former ascertains if outcome was due to chance, and requires a quantitative element
- Quantification of human nature uses arbitary cut-offs
- Solution: appreciate pitfalls of RCTs and adopt more qualitative research to exist alongside
- Meta-synthesis sits at a higher positon in the hierarchy of evidence
- Clinical significance does not necessarily equate to improvements in everday life
- Due to arbitary cut-offs in research (Kazdin, 2008)
- Solution: utilise EBP whihc incoporates clinican expertise, and session-by-session analysis to best improve individual circumstance
Outline NICE’s stance on clinical guidelines
NICE acknowledges and explicitely states:
- Lack of evidence does not equate to evidence of no effect
- Recommendations do not replace for clinical judgement