Efficacy of synchronous, virtual cognitive behavioral therapy for insomnia across phases of cancer survivorship: a study protocol

Kelcie D. Willis; Emma G. Balkind; Caleb Bolden; Alona Muzikansky; Mark J. Gorman; Amy Comander; Lynne Wagner; Joe Kossowsky; Elyse R. Park; Timur Mukhammadov; Tolulope Adewumi; Brandon Nies; Daniel L. Hall

doi:10.18203/2349-3259.ijct20253337

Authors

Kelcie D. Willis Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
Emma G. Balkind Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
Caleb Bolden Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
Alona Muzikansky Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
Mark J. Gorman Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
Amy Comander Harvard Medical School, Boston, MA, USA; Department of Medicine, Massachusetts General Hospital, Boston, MA, USA
Lynne Wagner Department of Health Policy and Management Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA
Joe Kossowsky Harvard Medical School, Boston, MA, USA; Department of Anaesthesia, Boston Children’s Hospital, Boston, MA, USA
Elyse R. Park Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA
Timur Mukhammadov Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
Tolulope Adewumi Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
Brandon Nies Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA
Daniel L. Hall Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA;Harvard Medical School, Boston, MA, USA

DOI:

https://doi.org/10.18203/2349-3259.ijct20253337

Keywords:

Insomnia, Cancer, Survivorship, Randomized Controlled Trial, Cognitive behavioral therapy, Sleep

Abstract

Background: Chronic insomnia affects up to 50% of cancer survivors, contributing to emotional distress, fatigue, and reduced quality of life. Cognitive behavioral therapy for insomnia (CBT-I) is the recommended first-line treatment, yet access remains limited, particularly for cancer survivors across different phases of survivorship. This study evaluates the efficacy of a synchronous, virtual CBT-I intervention targeted for cancer survivors survivorship sleep program (SSP) across curvivors, those in active treatment, and metavivors.

Methods: This randomized controlled efficacy trial will enroll 198 cancer survivors with clinically significant insomnia and will randomize participants 1:1 to the SSP (n=99) or enhanced usual care (EUC; n=99). SSP consists of four weekly 45-minute sessions and one booster session at week 6. The primary outcome is change in insomnia severity (ISI) from baseline (T0) to week 10 (T2). Secondary outcomes include subjective (sleep diary) and objective (Fitbit) sleep metrics, emotional distress, fatigue, sleep medication use, perceived cognitive functioning, work presenteeism/absenteeism, and health behaviors, assessed acutely (week 6; T1) and 3-months post-SSP (week 18; T0-T3). Exploratory outcomes include acceptability metrics and treatment effects by survivorship phase.

Conclusions: This trial addresses major gaps in the CBT-I literature by evaluating key subjective and objective sleep outcomes for cancer survivors across various phases of treatment. Findings will inform the scalable delivery of CBT-I in oncology, advancing access to evidence-based insomnia care.

Trial registration: NCT06181643.

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