Clinical trial NCT03532282: The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy
Official title: Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2018-05-22
Enrollment: 388
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: at baseline and at months 2, 4, 6, 9, & 12
measure: Use of Prescription Sleep Medication
timeFrame: at baseline and at months 2, 4, 6, 9, & 12
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
timeFrame: at baseline and at months 2, 4, 6, 9, & 12
measure: PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
timeFrame: at baseline and at months 2, 4, 6, 9, & 12
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Rachel Manber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Manber R, Gumport NB, Tully IA, Kim JP, Kim B, Simpson N, Rosas LG, Zulman DM, Goldhaber-Fiebert JD, Rangel E, Dietch JR, Tutek J, Palaniappan L. Effects of a Triage Checklist to optimize insomnia treatment outcomes and reduce hypnotic use: the RCT of the effectiveness of stepped-care sleep therapy in general practice study. Sleep. 2025 Jan 13;48(1):zsae182. doi: 10.1093/sleep/zsae182.
citation: Manber R, Tully IA, Palaniappan L, Kim JP, Simpson N, Zulman DM, Goldhaber-Fiebert JD, Rangel E, Dietch JR, Rosas LG. RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol. Contemp Clin Trials. 2022 May;116:106749. doi: 10.1016/j.cct.2022.106749. Epub 2022 Mar 30.