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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
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Sleep disturbances are considered a significant public health concern. The prevalence of disrupted sleep among US adults has increased to alarming levels. Around 70 million Americans suffer from a sleep disturbance. Reduced sleep and poor sleep quality have been linked to cardiovascular disease, increased risk for obesity, hypertension, heart attack, and stroke.
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).
The purpose of the study is to examine the effectiveness of the Headspace Health Sleep Program for improving both subjective sleep quality (i.e., self-reported surveys) as well as objective sleep quality (i.e. actigraphy) in a population with sleep disturbances. The study will employ a 2-arm app-based intervention involving 1 active intervention (i.e., Headspace Health Sleep Program) and a waitlist control for a duration of 18 days.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleep Program | Active Comparator |
| |
| Waitlist | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sleep Program | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | The ISI is a measure of sleep disturbance severity. ISI is a 7-item, self-report measure for the evaluation of insomnia. Items in the ISI concern difficulties falling asleep, problems staying asleep, daytime symptoms connected to the sleeping problem, and worrying about sleeping too little. Each item is rated from 0 to 4, giving the rating scale a maximum summed score of 28 points. According to the guidelines for interpretation, 0-7 should be interpreted as no clinically significant insomnia, 8-14 as subthreshold insomnia, 15-21 as clinical insomnia of moderate severity, and 22-28 as severe clinical insomnia. | Change from baseline to immediately post-intervention and 2-week follow-up |
| Sleep Diary | Participants will be asked to complete a daily sleep diary for the duration of the 1-week baseline assessment period and the 1-week post-intervention assessment and the 1-week follow-up period. The sleep diary will be used to measure sleep efficiency (SE) and total wake time (TWT). Sleep efficiency will be calculated by dividing the amount of time sleeping in bed by the amount of time spent in bed. Total sleep time will be calculated as the total amount of nightly sleep. In addition, the sleep diary will measure sleep onset latency (SOL), wake after sleep onset (WASO). The sleep diary data will be averaged across one week with a minimum of 4 nights required for inclusion. | Change from baseline to immediately post-intervention and 2-week follow-up |
| Actigraphy | A wrist actigraph will be worn on the non-dominant wrist of participants for the duration of the 1-week baseline assessment period and the 1-week post-intervention assessment period. In this study the investigators will use the research-grade GT3X actigraph (wGT3X-BT: ActiGraph, Pensacola, Florida, USA), which is a small (10.5 × 30.3 × 40.6 mm) and lightweight (19 g) triaxial accelerometer and is a research-grade device. The investigators will use the ActiLife (Version 6.13.1, ActiGraph, Pensacola, Florida, USA) data analysis software to extract the variables of interest. An algorithm yields approximate values for sleep efficiency, sleep onset latency, wake after sleep onset, movement time, total wake time (TWT) and sleep fragmentation. Participants will be instructed to wear the wrist actigraph continuously in the 1-week baseline and 1-week post intervention periods. Actigraphy data will be averaged across one week with a minimum of 4 nights required for inclusion. |
| Measure | Description | Time Frame |
|---|---|---|
| The Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a self-rated questionnaire which assesses sleep quality and disturbances. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Higher scores indicate worse sleep quality where poor sleep will be a PSQI total score of > 5. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Kirk, PhD | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fralin Biomedical Research Institute at VTC | Roanoke | Virginia | 24016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23141932 | Background | Altman NG, Izci-Balserak B, Schopfer E, Jackson N, Rattanaumpawan P, Gehrman PR, Patel NP, Grandner MA. Sleep duration versus sleep insufficiency as predictors of cardiometabolic health outcomes. Sleep Med. 2012 Dec;13(10):1261-70. doi: 10.1016/j.sleep.2012.08.005. Epub 2012 Nov 8. | |
| 33493753 | Background | Anderson T, Corneau G, Wideman L, Eddington K, Vrshek-Schallhorn S. The impact of prior day sleep and physical activity on the cortisol awakening response. Psychoneuroendocrinology. 2021 Apr;126:105131. doi: 10.1016/j.psyneuen.2021.105131. Epub 2021 Jan 14. |
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Aggregated data collected in this project will be de-identified and made available on a shared secured data repository. Results from this project will be shared and disseminated, including manuscripts will be written and submitted for publication in peer-reviewed journals/conferences. All necessary ethical approvals will be obtained.
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Data will be made available upon request after dissemination of results.
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| ID | Term |
|---|---|
| D020447 | Parasomnias |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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|
| Waitlist | Other | Participants will continue their regular sleep routines for an 18 day period and will not be assigned to an intervention. |
|
| Change from baseline to immediately post-intervention |
| Change from baseline to immediately post-intervention and 2-week follow-up |
| Perceived Stress Scale (PSS-10) | The PSS is a 10-item scale designed to measure the perception of stress within the past month. Participants use a Likert scale with responses ranging from 0 = never to 4 = very often. PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. Additionally, scores can be categorized as low (0-13), moderate (14-26), and high (27-40) perceived stress. | Change from baseline to immediately post-intervention and 2-week follow-up |
| Patient Health Questionnaire-8 (PHQ8) | The PHQ-8 is used to measure depression symptoms. The PHQ-8 consists of 8 items. Participants use a Likert scale ranging from 0 = not at all to 3 = nearly every day. The range of PHQ-8 scores is 0-24. | Change from baseline to immediately post-intervention and 2-week follow-up |
| General Anxiety Disorder-7 (GAD-7) | The GAD-7 is a 7-item self-report scale based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria for generalized anxiety disorder, with items scored from 0 (not at all) to 3 (nearly every day). | Change from baseline to immediately post-intervention and 2-week follow-up |
| Mindful Attention Awareness Scale (MAAS) | Mindfulness will be measured by the MAAS. The MAAS is a 15-item scale designed to assess a core characteristic of dispositional mindfulness. Each of the 15 items aims at measuring one's awareness of what is taking place at the present. The MAAS is answered on a five-point Likert scale. Higher scores reflect higher dispositional mindfulness. | Change from baseline to immediately post-intervention and 2-week follow-up |
| Sleep medication | Change in sleep medication will be assessed. Specifically, prescribed sleep medication, over-the-counter sleep aids, therapy, psychotropic medications (SSRIs/anxiety meds). | Change from baseline to immediately post-intervention and 2-week follow-up |
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| 17368098 | Background | Buysse DJ, Thompson W, Scott J, Franzen PL, Germain A, Hall M, Moul DE, Nofzinger EA, Kupfer DJ. Daytime symptoms in primary insomnia: a prospective analysis using ecological momentary assessment. Sleep Med. 2007 Apr;8(3):198-208. doi: 10.1016/j.sleep.2006.10.006. Epub 2007 Mar 23. |
| 6668417 | Background | Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available. |
| 24138364 | Background | Cunnington D, Junge MF, Fernando AT. Insomnia: prevalence, consequences and effective treatment. Med J Aust. 2013 Oct 21;199(8):S36-40. doi: 10.5694/mja13.10718. |
| 26727118 | Background | Grandner MA, Schopfer EA, Sands-Lincoln M, Jackson N, Malhotra A. Relationship between sleep duration and body mass index depends on age. Obesity (Silver Spring). 2015 Dec;23(12):2491-8. doi: 10.1002/oby.21247. Epub 2015 Nov 2. |
| 24333222 | Background | Grandner MA, Chakravorty S, Perlis ML, Oliver L, Gurubhagavatula I. Habitual sleep duration associated with self-reported and objectively determined cardiometabolic risk factors. Sleep Med. 2014 Jan;15(1):42-50. doi: 10.1016/j.sleep.2013.09.012. Epub 2013 Oct 28. |
| 18752852 | Background | 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. |
| 17442599 | Background | Knutson KL, Spiegel K, Penev P, Van Cauter E. The metabolic consequences of sleep deprivation. Sleep Med Rev. 2007 Jun;11(3):163-78. doi: 10.1016/j.smrv.2007.01.002. Epub 2007 Apr 17. |
| 21532953 | Background | Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601. |
| 21476952 | Background | Richey SM, Krystal AD. Pharmacological advances in the treatment of insomnia. Curr Pharm Des. 2011;17(15):1471-5. doi: 10.2174/138161211796197052. |
| 30575050 | Background | 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. |
| 36045915 | Background | 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. |
| 40267472 | Derived | 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. |