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Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial
Ben Colagiuri1, Louise Sharpe2, Zahava Ambarchi2
1School of Psychology, The University of Sydney, Sydney, New South Wales, Australia ben.colagiuri@sydney.edu.au.
BMJ Open
|February 27, 2021
Summary
Open-label placebo (OLP) and conventional placebo (CP) treatments were compared to no treatment for insomnia. This study investigated the ethical and effective use of placebos for sleep disorder management.
Area of Science:
- Sleep Medicine
- Clinical Psychology
- Medical Ethics
Background:
- Insomnia is a widespread sleep disorder with significant personal and societal impacts.
- Conventional placebo (CP) interventions for insomnia raise ethical concerns due to deceptive administration.
- Open-label placebo (OLP) offers a potential ethical alternative, but its efficacy for insomnia remains unestablished.
Purpose of the Study:
- To compare the efficacy and acceptability of OLP, CP, and no treatment for insomnia.
- To evaluate OLP as an ethical placebo intervention for sleep disorders.
- To explore predictors of treatment uptake and response in placebo interventions for insomnia.
Main Methods:
- A cohort multiple randomized controlled trial design was employed.
- 267 participants with insomnia (Insomnia Severity Index ≥10) were randomized into OLP, CP, or observational control groups.
- The primary outcome was the Insomnia Severity Index (ISI) post-treatment; secondary outcomes included sleep parameters, mood, and satisfaction.
Main Results:
- This section is not available in the provided abstract.
- Further analysis is required to determine the main results.
- The study is designed to yield significant data on placebo interventions for insomnia.
Conclusions:
- The study aims to determine if open-label placebo (OLP) is an effective and ethical treatment for insomnia.
- Findings will inform the use of placebo interventions in sleep medicine.
- This research addresses the ethical challenges of placebo use in clinical practice.
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