Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances

NCT05872672 | Completed

• 1 other identifier: 3425432
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Sleep Disturbance

Outcome Measures

Primary Outcomes (3)

• 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.

  Change from baseline to immediately post-intervention

Secondary Outcomes (6)

• The Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline to immediately post-intervention and 2-week follow-up

• Perceived Stress Scale (PSS-10)

  Change from baseline to immediately post-intervention and 2-week follow-up

• Patient Health Questionnaire-8 (PHQ8)

  Change from baseline to immediately post-intervention and 2-week follow-up

• General Anxiety Disorder-7 (GAD-7)

  Change from baseline to immediately post-intervention and 2-week follow-up

• Mindful Attention Awareness Scale (MAAS)

  Change from baseline to immediately post-intervention and 2-week follow-up

Study Arms (2)

Sleep Program

ACTIVE COMPARATOR

Behavioral: Sleep Program

Waitlist

OTHER

Other: Waitlist

Interventions

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).

Sleep Program

Waitlist OTHER

Participants will continue their regular sleep routines for an 18 day period and will not be assigned to an intervention.

Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A total score of 11 or greater on the Insomnia Severity Index (ISI).
• Fluency in English
• Own a smartphone that can support downloaded apps

You may not qualify if:

• Completed CBTi program in the past 6 months.
• Risk factors associated with severe insomnia such as depression and self-harm.

Sponsors & Collaborators

• University of Southern Denmark: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Fralin Biomedical Research Institute at VTC

Roanoke, Virginia, 24016, United States

Location

Related Publications (18)

• 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.

  PMID: 23141932 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.

  PMID: 33493753 BACKGROUND

• Arble DM, Bass J, Behn CD, Butler MP, Challet E, Czeisler C, Depner CM, Elmquist J, Franken P, Grandner MA, Hanlon EC, Keene AC, Joyner MJ, Karatsoreos I, Kern PA, Klein S, Morris CJ, Pack AI, Panda S, Ptacek LJ, Punjabi NM, Sassone-Corsi P, Scheer FA, Saxena R, Seaquest ER, Thimgan MS, Van Cauter E, Wright KP. Impact of Sleep and Circadian Disruption on Energy Balance and Diabetes: A Summary of Workshop Discussions. Sleep. 2015 Dec 1;38(12):1849-60. doi: 10.5665/sleep.5226.

  PMID: 26564131 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

  PMID: 12703651 BACKGROUND

• Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.

  PMID: 2748771 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.

  PMID: 17368098 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.

  PMID: 6668417 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.

  PMID: 24138364 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.

  PMID: 26727118 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.

  PMID: 24333222 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.

  PMID: 18752852 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.

  PMID: 17442599 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.

  PMID: 21532953 BACKGROUND

• Richey SM, Krystal AD. Pharmacological advances in the treatment of insomnia. Curr Pharm Des. 2011;17(15):1471-5. doi: 10.2174/138161211796197052.

  PMID: 21476952 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.

  PMID: 30575050 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.

  PMID: 36045915 BACKGROUND

• 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.

  PMID: 40267472 DERIVED

MeSH Terms

Conditions

Parasomnias

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Officials

• Ulrich Kirk, PhD

  University of Southern Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: May 24, 2023
• Study Start: November 1, 2023
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be made available upon request after dissemination of results.

Locations

US (1)