UQx PSYC1030.3x 1-4-2 Randomised controlled trials

Summary

Randomised Controlled Trials (RCTs) are the gold standard for evaluating interventions, requiring registration and a detailed protocol. Participants are randomly assigned to conditions like active intervention or a wait-list control, ensuring unbiased results. Assessments are conducted pre and post-intervention, with follow-ups at specified intervals. RCTs must be statistically powered to detect differences. An example illustrates RCTs where participants are assigned to 'Psychotherapy' or 'no treatment', with the latter receiving treatment post-assessment to avoid ethical issues.

Takeaways

• 🔬 Randomized Controlled Trials (RCTs) are considered the highest level of evidence for evaluating interventions.
• 📝 RCTs should be registered on a clinical trials register with a full protocol outlined for transparency.
• 🚫 Clear criteria for participant inclusion and exclusion must be defined to ensure the study's validity.
• 📈 Random assignment of participants to conditions is crucial for the study's integrity.
• 💊 Conditions may include active interventions, placebos, or wait list controls, with the latter providing a comparison to the passage of time.
• 📝 Assessments are conducted pre- and post-intervention, with additional follow-ups to measure long-term effects.
• 🕒 Follow-up points are typically specified at intervals, such as 6 and 12 months post-intervention, to evaluate sustained effects.
• 📉 Adequate power is necessary for an RCT to detect differences between conditions statistically.
• 📊 The example provided illustrates a trial comparing 'Psychotherapy' as an active intervention to a 'wait list control'.
• ⏳ In a wait list control, participants receive no treatment for the duration of the intervention period, allowing for the assessment of time's effect on symptoms.
• 👥 Ethical considerations mandate that after the trial, participants in the wait list control receive the active intervention.

Q & A

What is considered the 'gold standard' in evaluating an intervention?

Randomised Controlled Trials (RCTs) are typically regarded as the 'gold standard' in evaluating an intervention.

Where should Randomised Controlled Trials be registered?

They should be registered on a national or international clinical trials register.

What should be outlined in the clinical trials register for a Randomised Controlled Trial?

The full protocol for the trial, including criteria for participant inclusion and exclusion, recruitment, and procedures, should be outlined.

How are participants assigned to conditions in a Randomised Controlled Trial?

Participants must be randomly assigned to conditions, ensuring the study's objectivity and reliability.

What are the possible conditions in a Randomised Controlled Trial?

Conditions may include an active intervention, a placebo, or a wait list control where participants receive no treatment.

Why is it important to conduct assessments both before and after the intervention in an RCT?

Assessments are conducted to measure the effectiveness of the intervention and to compare the results with the initial state of the participants.

What is the purpose of follow-up points in a Randomised Controlled Trial?

Follow-up points, such as 6 and 12 months after the intervention, are specified to evaluate the long-term effects and sustainability of the intervention.

Why is it necessary to have enough participants in a Randomised Controlled Trial?

Adequate participant numbers are needed to ensure the trial is statistically powered to detect a difference between conditions if such a difference exists.

What is the ethical consideration for participants in the wait list control condition?

It is unethical to withhold treatment, so participants in the wait list control condition eventually receive an active intervention after the initial assessment.

Can you provide an example of a condition in a Randomised Controlled Trial as described in the script?

An example given in the script is the active intervention 'Psychotherapy' versus a 'no treatment' or wait list control condition.

What happens to the participants in the wait list control condition after the initial intervention period?

After the initial intervention period, such as 12 weeks of psychotherapy, participants in the wait list control condition are re-assessed and then receive an active intervention.