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

NCT03532282 | Completed Results DMC

• 2 other identifiers: 45874R01AG057500
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index (ISI)

  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.

  at baseline and at months 2, 4, 6, 9, & 12

• Use of Prescription Sleep Medication

  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.

  at baseline and at months 2, 4, 6, 9, & 12

Secondary Outcomes (2)

• Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire

  at baseline and at months 2, 4, 6, 9, & 12

• PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)

  at baseline and at months 2, 4, 6, 9, & 12

Study Arms (2)

ONLINE ONLY

ACTIVE COMPARATOR

Online cognitive behavioral therapy for insomnia

Behavioral: ONLINE ONLY

STEPPED CARE

EXPERIMENTAL

Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both

Behavioral: STEPPED CARE

Interventions

ONLINE ONLY BEHAVIORAL

Access to an online cognitive behavioral therapy for insomnia

ONLINE ONLY

STEPPED CARE BEHAVIORAL

A two step treatment that starts with either an online or therapist led cognitive behavioral therapy for insomnia, depending on a decision algorithm (checklist). Those with insufficient progress to the online treatment after 8 weeks are switched to a therapist-led treatment

STEPPED CARE

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• insomnia disorder

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

Related Publications (3)

• 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.

  PMID: 39115347 RESULT

• Tully IA, Kim JP, Simpson N, Palaniappan L, Tutek J, Gumport NB, Dietch JR, Manber R. Beliefs about prescription sleep medications and interest in reducing hypnotic use: an examination of middle-aged and older adults with insomnia disorder. J Clin Sleep Med. 2023 Jul 1;19(7):1247-1257. doi: 10.5664/jcsm.10552.

  PMID: 36883379 DERIVED

• 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.

  PMID: 35367385 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Results Point of Contact

• Title: Rachel Manber, PhD
• Organization: Stanford University

rmanber@stanford.edu

(650) 498-9111

Study Officials

• Rachel Manber, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 22, 2018
• Study Start: February 1, 2019
• Primary Completion: January 12, 2023
• Study Completion: January 12, 2023
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available 2 years after the publication of the results pertaining to the primary aims. Data will be available for 2 years after its release
• Access Criteria: Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with Stanford University.

Locations

US (1)