Evidence map›Paper›PMID 35367385›Full record

ArticleContemporary clinical trials2022

RCT of the effectiveness of stepped-care sleep therapy in general practice: The RESTING study protocol.

Rachel Manber, Isabelle A Tully, Latha Palaniappan, Jane P Kim, Norah Simpson, Donna M Zulman, Jeremy D Goldhaber-Fiebert, Elizabeth Rangel, Jessica R Dietch, Lisa G Rosas

Registry-linked trialOpen access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03532282 (Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03532282 nacompletednot on this map

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

TypeinterventionalSponsorStanford UniversityRan2019 to 2023Enrolled388ConditionsInsomniaArmsONLINE ONLY, STEPPED CARE
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Rachel ManberDepartment of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA. Electronic address: Rmanber@stanford.edu.
Isabelle A TullyDepartment of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA.
Latha PalaniappanDepartment of Health Policy, Stanford University School of Medicine, Stanford, CA 94305, USA.
Jane P KimDepartment of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA.
Norah SimpsonDepartment of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA.
Donna M ZulmanDepartment of Medicine, Stanford University School of Medicine, Stanford, CA 94305, USA.
Jeremy D Goldhaber-FiebertDepartment of Health Policy, Stanford University School of Medicine, Stanford, CA 94305, USA; Center for Health Policy, Freeman Spogli Institute, Stanford University, Stanford, CA 94305, USA.
Elizabeth RangelDepartment of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA; SDSU/ UC San Diego Joint Doctoral Program in Clinical Psychology, University of California, San Diego, San Diego State University, San Diego, CA 92120, USA.
Jessica R DietchDepartment of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA; School of Psychological Science, Oregon State University, Corvallis, OR 97331, USA.
Lisa G RosasCenter for Health Policy, Freeman Spogli Institute, Stanford University, Stanford, CA 94305, USA.
Stanford University · USOregon State University · US

Funding

Stanford Center for Clinical & Translational Education and Research (Spectrum)UL1TR003142 · NCATS · STANFORD UNIVERSITY · PI O'HARA, RUTH M · 2019 to 2023
$45.0M
Spectrum Stanford Center for clinical and Translational Research and EducationUL1TR001085 · NCATS · STANFORD UNIVERSITY · PI CULLEN, MARK RICHARD, GREENBERG, HARRY BERNARD · 2013 to 2017
$37.1M
RCT of the Effectiveness of Stepped-Care Sleep Therapy In General Practice (RESTING)R01AG057500 · NIA · STANFORD UNIVERSITY · PI MANBER, RACHEL · 2018 to 2022
$2.4M
NCATS NIH HHS UL1 TR001085NCATS NIH HHS UL1 TR003142NIA NIH HHS R01 AG057500
6 · The paper itself

Abstract

Cognitive behavioral therapy for insomnia (CBT-I) is an effective, non-pharmacological intervention, designated by the American College of Physicians as the first-line treatment of insomnia disorder. The current randomized controlled study uses a Hybrid-Type-1 design to compare the effectiveness and implementation potential of two approaches to delivering CBT-I in primary care. One approach offers therapy to all patients through an automated, digital CBT-I program (ONLINE-ONLY). The other is a triaged STEPPED-CARE approach that uses a simple Decision Checklist to start patients in either digital or therapist-led treatment; patients making insufficient progress with digital treatment at 2 months are switched to therapist-led treatment. We will randomize 240 individuals (age 50 or older) with insomnia disorder to ONLINE-ONLY or STEPPED-CARE arms. The primary outcomes are insomnia severity and hypnotic medication use, assessed at baseline and at months 2, 4, 6, 9, and 12 after randomization. We hypothesize that STEPPED-CARE will be superior to ONLINE-ONLY in reducing insomnia severity and hypnotic use. We also aim to validate the Decision Checklist and explore moderators of outcome. Additionally, guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, we will use mixed methods to obtain data on the potential for future dissemination and implementation of each approach. This triaged stepped-care approach has the potential to improve sleep, reduce use of hypnotic medications, promote safety, offer convenient access to treatment, and support dissemination of CBT-I to a large number of patients currently facing barriers to accessing treatment. Clinical trial registration:NCT03532282.

Indexed as

Cognitive Behavioral TherapyGeneral PracticeSleep Initiation and Maintenance DisordersHumansHypnotics and SedativesMiddle AgedRandomized Controlled Trials as TopicSleepTreatment OutcomeHypnotics and SedativesCognitive behavioral therapy for insomniaDigital therapyInsomniaRandomized controlled studyStepped-care

Identifiers

PMID35367385
PMCPMC10159730
OpenAlexW4220967049

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.