Digital Cognitive-Behavioral Therapy for Insomnia in Cancer Survivors: Protocol for a Pragmatic Clinical Trial

Maria Inês Clara; Annemieke van Straten; Maria Cristina Canavarro; Ana Allen Gomes

doi:10.20344/amp.21094

Authors

Maria Inês Clara Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC). Universidade de Coimbra. Coimbra; Faculty of Psychology and Educational Sciences. Universidade de Coimbra. Coimbra; Chronopsychology and Cognitive Systems Lab (ChronCog). Universidade de Coimbra. Coimbra. https://orcid.org/0000-0002-9099-033X
Annemieke van Straten Department of Clinical, Neuro and Developmental Psychology & Amsterdam Public Health Research Institute. Vrije Universiteit Amsterdam. Amsterdam. https://orcid.org/0000-0001-6875-2215
Maria Cristina Canavarro Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC). Universidade de Coimbra. Coimbra; Faculty of Psychology and Educational Sciences. Universidade de Coimbra. Coimbra. https://orcid.org/0000-0002-5083-7322
Ana Allen Gomes Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC). Universidade de Coimbra. Coimbra; Faculty of Psychology and Educational Sciences. Universidade de Coimbra. Coimbra; Chronopsychology and Cognitive Systems Lab (ChronCog). Universidade de Coimbra. Coimbra. https://orcid.org/0000-0002-8221-6985

DOI:

https://doi.org/10.20344/amp.21094

Keywords:

Cognitive Behavioral Therapy, Digital Health, Neoplasms/complications, Sleep Initiation and Maintenance Disorders

Abstract

Introduction: Insomnia is one of the most prevalent, persistent, and distressing conditions associated with cancer, affecting almost half of all cancer survivors. Although cognitive-behavioral therapy for insomnia is well established as the gold-standard treatment for insomnia, its accessibility is very limited in routine care. We aim to examine the real-world effectiveness and acceptability of a digital cognitive-behavioral therapy for insomnia for cancer survivors with insomnia symptoms through a randomized controlled trial in Portugal.
Methods and Analysis: Our cancer trial will test the effects and acceptability of an accessible internet-delivered self-administered cognitive-behavioral therapy for insomnia digital intervention with clinician support, OncoSleep. This online program includes six interactive, personalized weekly sessions featuring evidence-based techniques targeting psychophysiological hyperarousal and maladaptive conditioning, tailored for cancer survivors. Research study procedures include screening for eligibility in the general population and randomization into one of two arms: the digital CBT-I program or a waitlist control group. Insomnia severity (primary outcome), fatigue, sleep diary outcomes, psychological distress, and quality of life (secondary outcomes) will be assessed at baseline and post-intervention.

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