Pilot randomized controlled trial of eHealth cognitive-behavioral therapy for insomnia among Spanish-speaking breast cancer survivors

Laura B Oswald, Jennifer Morales-Cruz, Sarah L Eisel, Jocelyn Del Rio, Aasha I Hoogland, Vanessa Ortiz-Rosado, Grace Soto-Lopez, Edgar Rodriguez-Rivera, Josée Savard, Eida Castro, Heather S L Jim, Brian D Gonzalez, Laura B Oswald, Jennifer Morales-Cruz, Sarah L Eisel, Jocelyn Del Rio, Aasha I Hoogland, Vanessa Ortiz-Rosado, Grace Soto-Lopez, Edgar Rodriguez-Rivera, Josée Savard, Eida Castro, Heather S L Jim, Brian D Gonzalez

Abstract

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy.ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019).

Keywords: Breast cancer; Hispanic Americans; Insomnia; Randomized controlled trial; Sleep.

Conflict of interest statement

Dr. Jim is a paid consultant for RedHill BioPharma, Janssen Scientific Affairs, and Merck, and receives research support from Kite Pharma. Dr. Gonzalez is a paid consultant for SureMed Compliance, KemPharm, Elly Health. The other authors have no relevant conflicts of interest.

© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Figures

Fig. 1
Fig. 1
CONSORT diagram of study flow and retention
Fig. 2
Fig. 2
Average scores for (A) insomnia symptoms, (B) global sleep disturbance, and (C) sleep efficiency by study group at each time point. Error bars represent one standard deviation
Fig. 3
Fig. 3
Change in the proportion of participants meeting established thresholds for clinically significant insomnia symptoms (ISI score ≥ 8), sleep disturbance (PSQI score ≥ 5), and low sleep efficiency (

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Source: PubMed

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