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Trial record 1 of 455 for:    insomnia RESTING
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The RESTING Insomnia Study: Randomized Controlled Study on Effectiveness of Stepped-Care Sleep Therapy (RESTING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03532282
Recruitment Status : Active, not recruiting
First Posted : May 22, 2018
Last Update Posted : December 10, 2021
Sponsor:
Information provided by (Responsible Party):
Rachel Manber, Stanford University

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.

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: ONLINE ONLY Behavioral: STEPPED CARE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors
Primary Purpose: Treatment
Official Title: Randomized Controlled Study of the Effectiveness of Stepped-Care Sleep Therapy In General Practice
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : May 30, 2024

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. Those with insufficient progress to the online treatment after 8 weeks are switched to a therapist-led treatment




Primary Outcome Measures :
  1. Change in the Insomnia Severity Index (ISI) [ Time Frame: at baseline and at months 2, 4, 6, 9, & 12 ]
    Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity

  2. Change in the use of prescription sleep medication [ Time Frame: at baseline and at months 2, 4, 6, 9, & 12 ]
    the number of minimal effective doses of a given sleep medication over 7 nights; A greater number means that a person is taking more sleep medication, with a value of 0 meaning that the person is not taking any sleep medication.


Secondary Outcome Measures :
  1. Change in the 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. The range of scores is 8 to 40, with higher score representing greater perceived impairment in function related to sleep.

  2. Change in the 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532282


Locations
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United States, California
Stanford University
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Rachel Manber, PhD Stanford University
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Responsible Party: Rachel Manber, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT03532282    
Other Study ID Numbers: 45874
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: December 10, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The researchers will share fully de-identified data on: the two primary outcomes, allocation to arm, and demographic.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders