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

December 17, 2024 updated by: Rachel Manber, Stanford University

Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

388

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ONLINE ONLY
Online cognitive behavioral therapy for insomnia
Behavioral: ONLINE ONLY
Access to an online cognitive behavioral therapy for insomnia
Experimental: STEPPED CARE
Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both
Behavioral: STEPPED CARE
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: 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.
at baseline and at months 2, 4, 6, 9, & 12
Use of Prescription Sleep Medication
Time Frame: 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.
at baseline and at months 2, 4, 6, 9, & 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
Time Frame: 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.
at baseline and at months 2, 4, 6, 9, & 12
PHQ-4 (The 4 Item Patient Health Questionnaire For Anxiety and Depression)
Time Frame: 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).
at baseline and at months 2, 4, 6, 9, & 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Rachel Manber, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2019

Primary Completion (Actual)

January 12, 2023

Study Completion (Actual)

January 12, 2023

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45874
  • R01AG057500 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The researchers will share fully de-identified data on: the two primary outcomes, allocation to arm, and demographic.

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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