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Completed

NCT Number: NCT03532282

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

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ONLINE ONLY

Behavioral

Access to an online cognitive behavioral therapy for insomnia

Stepped Care

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: RESTING

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 22, 2018
Registry last updated
Dec 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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