RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol.
Contemp Clin Trials
; 116: 106749, 2022 05.
Article
in En
| MEDLINE
| ID: mdl-35367385
ABSTRACT
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 registrationNCT03532282.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Cognitive Behavioral Therapy
/
General Practice
/
Sleep Initiation and Maintenance Disorders
Type of study:
Clinical_trials
/
Evaluation_studies
/
Guideline
/
Prognostic_studies
Limits:
Humans
/
Middle aged
Language:
En
Journal:
Contemp Clin Trials
Journal subject:
MEDICINA
/
TERAPEUTICA
Year:
2022
Document type:
Article