Open-label placebo for insomnia (OPIN): study protocol for a cohort multiple randomised controlled trial.

ABSTRACT:

Introduction

Insomnia is a prevalent sleep disorder that causes substantial personal and societal harm. There is evidence that placebo interventions can reduce insomnia symptoms, but this research has involved deceptively administering the placebo under the guise of a real medication (conventional placebo, CP), which has obvious ethical constraints. Open-label placebo (OLP) treatment, in which a placebo is administered with full disclosure that there are no active ingredients, has been proposed as a method of using the placebo effect ethically, but the efficacy and acceptability of OLP for insomnia is currently unknown.

Methods and analysis

This study uses a cohort multiple randomised controlled trial design to compare OLP, CP and no treatment for insomnia. Two-hundred and s

SUBMITTER: Colagiuri B 

PROVIDER: S-EPMC7919597 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature