Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances
NCT ID: NCT05872672
Last Updated: 2024-06-05
Study Results
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Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2023-11-01
2024-04-15
Brief Summary
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Sleep disturbances are characterized by dissatisfaction with sleep quality or sleep quantity, which may be associated with difficulties initiating sleep, difficulties maintaining sleep, or early-morning awakenings with an inability to return to sleep. Sleep disturbances including insomnia can be treated with pharmacological treatments. However, individuals often report adverse side effects. Increasing attention has therefore been paid to behavioral and psychological interventions, such as cognitive behavioral therapy and mindfulness.
The study will assess a smartphone-based sleep program by Headspace Health that combines cognitive behavioral therapy for insomnia (CBTi) and mindfulness concepts to minimize nocturnal symptoms and waking consequences associated with sleep disturbances.
The study aims to test the effectiveness of the Headspace Health Sleep Program on self-reported outcomes related to sleep quality. A secondary aim is to test objective measures of sleep quality using actigraphy.
The Headspace Health Sleep Program is an 18 day program based on CBTi, which includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
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Detailed Description
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A set of outcome measures will be used to evaluate the Headspace Health Sleep Program vs. a waitlist control group. The Insomnia Severity Index (ISI) will be used as a primary outcome measure as well as the Sleep Diary, and actigraphy. In addition, secondary outcome measures include Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10), Patient Health Questionnaire-8 (PHQ-8), General Anxiety Disorder-7 (GAD-7) and Mindful Attention Awareness Scale (MAAS). Baseline measures will be taken prior to randomization, and at post-intervention. 2 weeks following the post-intervention assessment, participants will again be asked to report sleep quality using self-reported surveys.
Eligible participants will complete a 1-week baseline assessment period. Participants will be supplied with a wrist actigraph and sleep diary. On the first day of the assessment period, participants will be instructed to start wearing the wrist actigraph. They will also be instructed to complete the sleep diary the following morning. Participants will continue this procedure of filling in the sleep diary every morning for the 1-week baseline assessment period and wearing the wrist actigraph. Following the 1-week baseline assessment period, participants will be asked to return the sleep diary, wrist actigraph, and complete baseline questionnaires (i.e., ISI, PSQI, PSS-10, PHQ8, GAD7, MAAS). They will then be randomized into one of two groups (Headspace Health Sleep Program or waitlist control). Having completed the intervention, participants will be scheduled for the 1-week post-intervention assessment period. Participants will again be supplied with a wrist actigraph, and sleep diary. At the end of this 1-week post-intervention assessment period, participants will return the sleep diary, wrist actigraph, and complete questionnaires (i.e., ISI, PSQI, PSS-10, PHQ8, GAD7, MAAS). 2 weeks following the post-intervention, participants will be asked to complete the sleep diary for a 1-week follow-up assessment period and in addition the ISI, PSQI, PSS-10, PHQ8, GAD7 and MAAS.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Sleep Program
Sleep Program
Participants will complete the Headspace Health Sleep Program, which is an 18 day program based on CBTi, and includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Waitlist
Waitlist
Participants will continue their regular sleep routines for an 18 day period and will not be assigned to an intervention.
Interventions
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Sleep Program
Participants will complete the Headspace Health Sleep Program, which is an 18 day program based on CBTi, and includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Waitlist
Participants will continue their regular sleep routines for an 18 day period and will not be assigned to an intervention.
Eligibility Criteria
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Inclusion Criteria
* Fluency in English
* Own a smartphone that can support downloaded apps
Exclusion Criteria
* Risk factors associated with severe insomnia such as depression and self-harm.
18 Years
ALL
No
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Ulrich Kirk
Associate Professor
Principal Investigators
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Ulrich Kirk, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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Fralin Biomedical Research Institute at VTC
Roanoke, Virginia, United States
Countries
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References
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Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
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Rusch HL, Rosario M, Levison LM, Olivera A, Livingston WS, Wu T, Gill JM. The effect of mindfulness meditation on sleep quality: a systematic review and meta-analysis of randomized controlled trials. Ann N Y Acad Sci. 2019 Jun;1445(1):5-16. doi: 10.1111/nyas.13996. Epub 2018 Dec 21.
Vyhlidal T, Dygryn J, Chmelik F. Actigraphy-Based Characteristics of Sleep in Paediatric Cancer Patients in Remission and a Comparison with Their Healthy Peers in the Recovery Stay. Nat Sci Sleep. 2022 Aug 25;14:1449-1456. doi: 10.2147/NSS.S374234. eCollection 2022.
Staiano W, Callahan C, Davis M, Tanner L, Coe C, Kunkle S, Kirk U. Assessment of an App-Based Sleep Program to Improve Sleep Outcomes in a Clinical Insomnia Population: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2025 Apr 23;13:e68665. doi: 10.2196/68665.
Other Identifiers
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3425432
Identifier Type: -
Identifier Source: org_study_id
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