Efficacy and safety of digital therapeutic application of Sleep Index-Based Treatment for Insomnia (dSIBT-I): a pilot study.
J Sleep Res
; 33(1): e14039, 2024 Feb.
Article
en En
| MEDLINE
| ID: mdl-37704214
ABSTRACT
The aim of this study was to evaluate the safety and efficacy of digital therapeutic application of Sleep Index-Based Treatment for Insomnia (dSIBT-I) and compare them with those of digital application of Cognitive Behavioural Therapy for Insomnia (dCBT-I). This randomised prospective pilot study was conducted at the Asan Medical Center. A total of 50 patients with insomnia were recruited between December 2022 and January 2023 and randomly allocated to the dSIBT-I or dCBT-I group. The study was carried out for one month. The primary outcome was the significant reduction in Insomnia Severity Index score at Week 4 compared to baseline, while the secondary outcome was proportion of participants whose Insomnia Severity Index scores were reduced to <15 at Week 4. We performed linear mixed model and generalised estimating equation analyses. Both dSIBT-I and dCBT-I groups showed significant improvements in Insomnia Severity Index scores at Week 4. There was no significant difference between two groups in terms of Insomnia Severity Index scores at Week 4 (group × time effect, F = 1.07, p = 0.382) and proportion of participants whose Insomnia Severity Index scores were reduced to <15 at Week 4 (group × time effects, F = 1.80, p = 0.615). However, at Week 2, the dSIBT-I group showed better results than the dCBT-I group in terms of both Insomnia Severity Index scores (p = 0.044) and proportion of participants whose Insomnia Severity Index scores were reduced to <15 (82.6% vs. 48.0%, p = 0.017). No treatment-emergent adverse events were reported in either group. The dSIBT-I is a safe and effective therapy for insomnia, with rapid treatment effects.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Trastornos del Inicio y del Mantenimiento del Sueño
Tipo de estudio:
Clinical_trials
/
Prognostic_studies
Límite:
Humans
Idioma:
En
Revista:
J Sleep Res
Asunto de la revista:
PSICOFISIOLOGIA
Año:
2024
Tipo del documento:
Article
País de afiliación:
Corea del Sur