RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol.
Cognitive behavioral therapy for insomnia
Digital therapy
Insomnia
Randomized controlled study
Stepped-care
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
received:
25
10
2021
revised:
07
03
2022
accepted:
28
03
2022
pubmed:
4
4
2022
medline:
25
5
2022
entrez:
3
4
2022
Statut:
ppublish
Résumé
Cognitive behavioral therapy for insomnia (CBT-I) is an effective, non-pharmacological intervention, designated by the American College of Physicians as the first-line treatment of insomnia disorder. The current randomized controlled study uses a Hybrid-Type-1 design to compare the effectiveness and implementation potential of two approaches to delivering CBT-I in primary care. One approach offers therapy to all patients through an automated, digital CBT-I program (ONLINE-ONLY). The other is a triaged STEPPED-CARE approach that uses a simple Decision Checklist to start patients in either digital or therapist-led treatment; patients making insufficient progress with digital treatment at 2 months are switched to therapist-led treatment. We will randomize 240 individuals (age 50 or older) with insomnia disorder to ONLINE-ONLY or STEPPED-CARE arms. The primary outcomes are insomnia severity and hypnotic medication use, assessed at baseline and at months 2, 4, 6, 9, and 12 after randomization. We hypothesize that STEPPED-CARE will be superior to ONLINE-ONLY in reducing insomnia severity and hypnotic use. We also aim to validate the Decision Checklist and explore moderators of outcome. Additionally, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, we will use mixed methods to obtain data on the potential for future dissemination and implementation of each approach. This triaged stepped-care approach has the potential to improve sleep, reduce use of hypnotic medications, promote safety, offer convenient access to treatment, and support dissemination of CBT-I to a large number of patients currently facing barriers to accessing treatment. Clinical trial registration:NCT03532282.
Identifiants
pubmed: 35367385
pii: S1551-7144(22)00075-1
doi: 10.1016/j.cct.2022.106749
pmc: PMC10159730
mid: NIHMS1888761
pii:
doi:
Substances chimiques
Hypnotics and Sedatives
0
Banques de données
ClinicalTrials.gov
['NCT03532282']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106749Subventions
Organisme : NIA NIH HHS
ID : R01 AG057500
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR001085
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR003142
Pays : United States
Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
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