Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm phase II feasibility and proof-of-concept trial

Ashlee R Loughan; Autumn Lanoye; Kelcie D Willis; Amber Fox; Scott G Ravyts; Alicia Zukas; Youngdeok Kim

doi:10.1093/neuonc/noad193

Telehealth group Cognitive-Behavioral Therapy for Insomnia (CBT-I) in primary brain tumor: Primary outcomes from a single-arm phase II feasibility and proof-of-concept trial

Neuro Oncol. 2024 Mar 4;26(3):516-527. doi: 10.1093/neuonc/noad193.

Authors

Ashlee R Loughan^{1

2}, Autumn Lanoye^{2

3}, Kelcie D Willis⁴, Amber Fox⁴, Scott G Ravyts⁵, Alicia Zukas⁶, Youngdeok Kim⁷

Affiliations

¹ Department of Neurology, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
² Massey Comprehensive Cancer Center, Virginia Commonwealth University, Richmond, Virginia, USA.
³ Department of Internal Medicine, School of Medicine, Virginia Commonwealth University, Richmond, Virginia, USA.
⁴ Department of Psychology, Virginia Commonwealth University, Richmond, Virginia, USA.
⁵ Department of Physical Medicine and Rehabilitation, Johns Hopkins University, Baltimore, Maryland, USA.
⁶ Department of Neurosurgery, Medical College of South Carolina, Charleston, South Carolina, USA.
⁷ Department of Kinesiology and Health Sciences, Virginia Commonwealth University, Richmond, Virginia, USA.

PMID: 37796017
PMCID: PMC10911999 (available on 2024-10-05)
DOI: 10.1093/neuonc/noad193

Abstract

Background: Cognitive-Behavioral Therapy for Insomnia (CBT-I), the frontline treatment for insomnia, has yet to be evaluated among patients with primary brain tumors (PwPBT) despite high prevalence of sleep disturbance in this population. This study aimed to be the first to evaluate the feasibility, safety, and acceptability of implementing telehealth group CBT-I as well as assessing preliminary changes in subjective sleep metrics in PwPBT from baseline to follow-up.

Methods: Adult PwPBT were recruited to participate in six 90-min telehealth group CBT-I sessions. Feasibility was assessed by rates of screening, eligibility, enrollment, and data completion. Safety was measured by participant-reported adverse events. Acceptability was assessed by retention, session attendance, satisfaction, recommendation of program to others, and qualitative feedback. Participant subjective insomnia severity, sleep quality, and fatigue were assessed at baseline, post intervention, and 3-month follow-up.

Results: Telehealth group CBT-I was deemed safe. Following the 76% screening rate, 85% of interested individuals met study eligibility and 98% enrolled (N = 44). Ninety-one percent of enrolled participants completed measures at baseline, 79% at post intervention, and 73% at 3-month follow-up. Overall, there was an 80% retention rate for the 6-session telehealth group CBT-I intervention. All participants endorsed moderate-to-strong treatment adherence and 97% reported improved sleep. Preliminary pre-post intervention effects demonstrated improvements in subjective insomnia severity, sleep quality, and fatigue with large effect sizes. These effects were maintained at follow-up.

Conclusions: Results of this proof-of-concept trial indicate that telehealth group CBT-I is feasible, safe, and acceptable among PwPBT, providing support for future randomized controlled pilot trials.

Trial registration: ClinicalTrials.gov NCT04919993.

Keywords: Cognitive–Behavioral Therapy for Insomnia (CBT-I); insomnia; primary brain tumor; sleep disturbance.

Publication types

Clinical Trial, Phase II
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural

MeSH terms

Adult
Cognitive Behavioral Therapy* / methods
Fatigue
Feasibility Studies
Humans
Sleep Initiation and Maintenance Disorders* / therapy
Telemedicine*
Treatment Outcome

Associated data

ClinicalTrials.gov/NCT04919993

Grants and funding

UG1 CA189867/CA/NCI NIH HHS/United States