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

June 3, 2024 updated by: Ulrich Kirk, University of Southern Denmark

Assessment of a Behavioral Sleep Program Using Subjective and Objective Measures of Sleep Quality in a Population With Sleep Disturbances

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24016
        • Fralin Biomedical Research Institute at VTC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Waitlist
Other: Waitlist
Participants will continue their regular sleep routines for an 18 day period and will not be assigned to an intervention.
Active Comparator: Sleep Program
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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
Time Frame: Change from baseline to immediately post-intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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.
Change from baseline to immediately post-intervention and 2-week follow-up
Perceived Stress Scale (PSS-10)
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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)
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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)
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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)
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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
Time Frame: Change from baseline to immediately post-intervention and 2-week follow-up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

Virginia Polytechnic Institute and State University

Investigators

  • Principal Investigator: Ulrich Kirk, PhD, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

April 15, 2024

Study Completion (Actual)

April 15, 2024

Study Registration Dates

First Submitted

May 8, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

May 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 5, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3425432

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be made available upon request after dissemination of results.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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