The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy
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About
This project aims to compare the effectiveness and implementation potential of two primary care friendly approaches to delivering an effective non-pharmacological intervention - cognitive behavioral therapy - for insomnia to middle aged and older adults.
Full description
All participants will receive cognitive behavioral therapy for insomnia, either through an online program or through visit with a therapist specializing in behavioral sleep medicine, and is some cases both. Participants will be randomized with equal probability to an ONLINE ONLY treatment arm or to a STEPPED CARE arm, whereby they will be assigned to on line or therapist-led treatment, based on their clinical presentation; but those assigned to this arm who start treatment with an online program and do not have sufficient response after 2 months will be switched over to a therapist-led treatment.
Enrollment
Sex
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Volunteers
Inclusion criteria
- insomnia disorder
Exclusion criteria
- Unable to be consented in English without an interpreter
- In poor physical or mental that limits capacity to participate in study treatment (e.g., Mini-Mental State Examination score < 25)
- Unable to use the internet
- Study physician determines participation is not medically advised for any reason
Trial design
Primary purpose
Allocation
Interventional model
Masking
388 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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