N/A
N=245
The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT03532282 ↗Enrolled (actual)
245
Serious AEs
0.8%
Results posted
Dec 2024
Primary outcome: Primary: Insomnia Severity Index (ISI) — 15.9; 15.4; 12.7; 11.6 score on a scale — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ONLINE ONLY (Behavioral); STEPPED CARE (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Insomnia Severity Index (ISI) |
15.9; 15.4; 12.7; 11.6; 11.6; 10.0 | 0.001 sig |
| PRIMARY Use of Prescription Sleep Medication |
0.372; 0.333; 0.357; 0.271; 0.340; 0.202 | 0.01 sig |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire |
56.8; 56.8; 53.7; 53.4; 53.1; 52.1 | 0.0006 sig |
| SECONDARY PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression) |
2.21; 2.46; 2.63; 2.46; 2.64; 2.59 | 0.05 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03532282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.