Assessment of a Behavioral Sleep Program in a Population With Sleep Disturbances
Completed · Not applicable
Conditions studied: Sleep Disturbance
In brief
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).
Key facts
- Study ID
- NCT05872672
- Run by
- University of Southern Denmark
- People needed
- 132
- Starts
- 2023-11-01
- Expected to finish
- 2024-04-15
- Last updated by the study team
- 2024-06-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- Fralin Biomedical Research Institute at VTC — Roanoke, Virginia, United States
Full record on ClinicalTrials.gov
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