InsomniaRESTINGNCT03532282

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

A study testing ONLINE ONLY and STEPPED CARE in people with Insomnia, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Insomnia
What is being tested?: ONLINE ONLY and STEPPED CARE
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 388 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2019to 12 Jan 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

insomnia disorder

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Palo Alto, California, 94305

Other trials in United States

About this study

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

Read the 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.

Conditions: Insomnia
Being tested: ONLINE ONLY, STEPPED CARE
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ONLINE ONLYBehavioural
Access to an online cognitive behavioral therapy for insomnia
STEPPED CAREBehavioural
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

Study groups in NCT03532282
Study group	Role	What they receive
ONLINE ONLY	Active comparator	Online cognitive behavioral therapy for insomnia Receives: Behavioral: ONLINE ONLY
STEPPED CARE	Experimental	Cognitive behavioral therapy for insomnia online or therapist-led or sequentially both Receives: Behavioral: STEPPED CARE

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: at baseline and at months 2, 4, 6, 9, & 12

Secondary outcomes (2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201912 Jan 2023

First posted22 May 2018
Study start1 Feb 2019
Primary completion12 Jan 2023
Study completion12 Jan 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for InsomniaStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 388 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03532282
Sponsor's protocol ID: 45874
Other IDs: R01AG057500
Acronym: RESTING
Status last verified: Dec 2024
First submitted: 1 May 2018
Last updated: 19 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: The researchers will share fully de-identified data on: the two primary outcomes, allocation to arm, and demographic.

Publications

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.
PubMed 39115347
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.
PubMed 36883379
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.
PubMed 35367385

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Insomnia trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice
ClinicalTrials.gov ID: NCT03532282
Acronym / sponsor ID: RESTING / 45874
Conditions: Insomnia
Study type: Interventional
Recruitment status: Completed
Enrolment: 388 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 1 Feb 2019 (actual)
Primary completion: 12 Jan 2023 (actual)
Study completion: 12 Jan 2023 (actual)
First posted: 22 May 2018 (actual)
Results: Posted 19 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ONLINE ONLY	Active comparator	Behavioral: ONLINE ONLYOnline cognitive behavioral therapy for insomnia
STEPPED CARE	Experimental	Behavioral: STEPPED CARECognitive behavioral therapy for insomnia online or therapist-led or sequentially both

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

insomnia disorder

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ONLINE ONLYAccess to an online cognitive behavioral therapy for insomnia	Behavioural	ONLINE ONLY
STEPPED CAREA 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	Behavioural	STEPPED CARE

Primary outcome

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.
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.

2 secondary outcomes

Patient-Reported Outcomes Measurement Information System (PROMIS) - Sleep Related Impairment Questionnaire
Time frame: 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

Results and safety

Results posted to the registry on 19 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ONLINE ONLY (ONLN)	121	102
STEPPED CARE (STEP)	124	108

Primary outcome: Insomnia Severity Index (ISI)

Time frame: at baseline and at months 2, 4, 6, 9, & 12. Mean (Standard Deviation). Unit: score on a scale

Measure	ONLN n = 121	STEP n = 124
Baseline	15.9 (4.25)	15.4 (4.14)
2-month	12.7 (5.00)	11.6 (4.75)
4-month	11.6 (4.98)	10.0 (4.75)
6-month	11.3 (4.93)	9.45 (4.71)
9-month	10.8 (4.76)	9.12 (4.94)
12-month	10.8 (5.16)	8.23 (4.99)

ONLN vs STEP: coefficient beta for change trajectory: -0.15, p = 0.001, Mixed Models Analysis

Population analysed: Intent to treat sample; values for participants with available data at the respective time point

Primary outcome: Use of Prescription Sleep Medication

Time frame: at baseline and at months 2, 4, 6, 9, & 12. Mean (Standard Deviation). Unit: Average number of minimal doses

Measure	ONLN n = 121	STEP n = 124
Baseline	0.372 (0.756)	0.333 (0.817)
2-month	0.357 (0.792)	0.271 (0.660)
4-month	0.340 (0.780)	0.202 (0.842)
6-month	0.352 (0.752)	0.178 (0.638)
9-month	0.396 (0.929)	0.130 (0.372)
12-month	0.375 (0.872)	0.205 (0.874)

ONLN vs STEP: coefficient beta for change trajectory: -0.01, p = 0.01, Mixed Models Analysis

Population analysed: Intent to treat sample; values for participants with available data at the respective time point

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ONLN	1 of 121 (0.8%)	8 of 121 (6.6%)	1 of 121
STEP	1 of 124 (0.8%)	9 of 124 (7.3%)	1 of 124

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39115347Manber 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.
Derived from this study: PubMed 36883379Tully 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.
Derived from this study: PubMed 35367385Manber 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.
Individual participant dataSharing planned: Yes. The researchers will share fully de-identified data on: the two primary outcomes, allocation to arm, and demographic.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rachel Manber, PhD principal investigator

Stanford University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing ONLINE ONLY and STEPPED CARE in people with Insomnia, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) (time frame: at baseline and at months 2, 4, 6, 9, & 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532282, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2024.