Paradoxical intention as a treatment for insomnia disorder: study protocol for a mixed-methods pilot trial.

INTRODUCTION

Paradoxical intention (PI) is an insomnia treatment developed in the 1970s, which instructs patients to gently attempt to remain awake while in bed at night with the lights off. Previous research indicates PI's potential in improving insomnia, although no study has been conducted in the last few decades during which the insomnia diagnostic criteria have changed. Additionally, there are knowledge gaps regarding outcomes related to wake after sleep onset, the treatment mechanisms as well as the acceptability and feasibility of the treatment. This study therefore aims to address these gaps by assessing the potential mechanisms, preliminary efficacy, and patient experience and acceptability of PI.

METHODS AND ANALYSIS

We aim to include 40 adult participants with insomnia, aged 18 and above, from the Swedish general population. In this uncontrolled pilot study using a mixed-methods approach, both qualitative and quantitative data will be collected. The trial will be conducted on a self-help online platform, accessible from participants' homes, with weekly phone call support by therapists. Process and outcome measures will be assessed weekly across a 4-week intervention period and at a 3-month follow-up. A subset of participants will be asked to participate in qualitative semistructured interviews regarding the treatment.

ETHICS AND DISSEMINATION

Ethical approval for this project has been granted by the Swedish Ethical Review Authority (Dnr: 2023-06594-01). All participants will sign informed consent forms on a web service application prior to enrolment. From this mixed-methods study, we anticipate insights into the preliminary efficacy and mechanisms of paradoxical intention for treating insomnia, enriched by patient experience data. Results will be disseminated through peer-reviewed publications. The findings will inform adaptations to the treatment protocol and serve as groundwork for a possible larger scale randomised controlled trial.

TRIAL REGISTRATION NUMBER

NCT06259682.