The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy

Not Applicable

Completed

• Conditions: Insomnia
• Interventions: Behavioral: STEPPED CARE; Behavioral: ONLINE ONLY

• Registration Number: NCT03532282
• Lead Sponsor: Stanford University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-05-01
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-22
• Study Start: 2019-02-01
• Primary Completion: 2023-01-12
• Study Completion: 2023-01-12
• Status Verified: 2024-12
• Results First Submitted: 2024-12-09
• Results First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Results First Posted: 2024-12-19
• Last Update Posted: 2024-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 388

Inclusion Criteria

• insomnia disorder

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEPPED CARE	STEPPED CARE	Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
ONLINE ONLY	ONLINE ONLY	Online cognitive behavioral therapy for insomnia

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI)	at baseline and at months 2, 4, 6, 9, & 12	The ISI is an empirically validated 7-item questionnaire, with each item rated on a 0 to 4 scale. The score is the sum of the 7 items. scores range between 0 and 28 (higher score corresponds with greater insomnia severity), with 10 as a cutoff score for identifying individuals in the community who are likely to meet criteria for insomnia disorder and 8 as a cutoff for defining remission.
Use of Prescription Sleep Medication	at baseline and at months 2, 4, 6, 9, & 12	The average number of minimal effective doses of prescription sleep medications taken; A greater number means that the person was taking number of minimal effective doses of prescription sleep medications, with a value of 0 meaning that the person is not taking any prescription sleep medication.

Secondary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire	at baseline and at months 2, 4, 6, 9, & 12	Questionnaire measuring sleep related impairment using T-scores, with a population mean of 50 and a standard deviation of 10. T-scores of 55-60 represent mild impairment; 60-70 represent moderate impairment; 70-80 represent severe impairment.
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)	at baseline and at months 2, 4, 6, 9, & 12	A validated questionnaire measuring depressive and anxiety symptom severity. The total score ranges between 0 and 12. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States