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

NCT ID: NCT03532282

Last Updated: 2024-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

388 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2023-01-12

Brief Summary

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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

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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

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Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors

Study Groups

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ONLINE ONLY

Online cognitive behavioral therapy for insomnia

Group Type ACTIVE_COMPARATOR

ONLINE ONLY

Intervention Type BEHAVIORAL

Access to an online cognitive behavioral therapy for insomnia

STEPPED CARE

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

Group Type EXPERIMENTAL

STEPPED CARE

Intervention Type 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

Interventions

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ONLINE ONLY

Access to an online cognitive behavioral therapy for insomnia

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Rachel Manber

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rachel Manber, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Palo Alto, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 39115347 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36883379 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35367385 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01AG057500

Identifier Type: NIH

Identifier Source: secondary_id

View Link

45874

Identifier Type: -

Identifier Source: org_study_id