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Examining the effectiveness of two smartphone applications for improving symptoms of insomnia

Examining the effectiveness of two smartphone applications for improving symptoms of insomnia

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000605493
Enrollment
38
Registered
2016-05-10
Start date
2016-02-08
Completion date
2016-08-08
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Insomnia is considered a public health concern associated with economic burden, reduced quality of life, and poor mental and physical health. Insomnia is characterised by complaints of dissatisfaction with sleep quality or quantity associated with difficulties initiating sleep, difficulties maintaining sleep, or early-morning awakenings with an inability to return to sleep. In addition to sleep disturbances, insomnia may be associated with a number of daytime complaints such as cognitive difficulties and mood disturbances, and is often characterised by heightened physiological and mental activation known as hyperarousal. Insomnia can be treated with pharmacotherapy; however, patients often report adverse side effects and a preference for non-pharmacological interventions. Increasing attention has therefore been paid to behavioural and psychological interventions, as well as complementary and alternate medicines such as mindfulness. Mindfulness incorporates awareness, of present experience, with acceptance. Current theoretical models suggests that mindfulness improves insomnia by changing the relationship that individuals have with negative sleep-related thoughts such as "I need 8 hours of sleep to function the next day", and by non-judgmentally observing and accepting spontaneously occurring physical and psychological processes that often inhibit sleep. Uncontrolled and controlled studies have demonstrated the effectiveness of group mindfulness-based interventions in improving self-reported sleep (e.g. Ong, Shapiro, & Manber, 2008; Ong, Manber, Segal, Xia, Shapiro, & Wyatt, 2014). Emerging research has also demonstrated improvements in pre-sleep arousal, insomnia severity, mood, stress, and objectively measured sleep, though the effects of mindfulness on these variables remain less clear. Research to date has not investigated the effectiveness of self-help mindfulness-based interventions for insomnia. Self-help interventions, such as the use of a mindfulness-based smartphone applications, may therefore provide a promising avenue in which to increase the access to, and use of, psychological interventions. Mindfulness-based smartphone applications have become increasingly accessible to the general public, though very few applications have been empirically evaluated and no research to date has been conducted within insomnia . If mindfulness-based mobile applications are found to be effective, the number of individuals obtaining psychological support could increase considerably. The proposed study therefore aims to examine the effectiveness of the mindfulness-based mobile application 'Headspace' for improving self-report and objective measures of sleep, pre-sleep arousal, cognitive performance, mood, and mindfulness skills in those with symptoms of insomnia.

Interventions

Mindfulness smartphone application, developed by Headspace and commercially available. The application takes the user through daily guided mindfulness meditations lasting approximately 10 minutes each, for 60 days. Participants will be asked to complete one guided-meditation exercise per day during the day time, and will be explicitly instructed to not use the application as a method to fall asleep. For the first 30 days of the intervention, participants will learn basic mindfulness skills. For

Mindfulness smartphone application, developed by Headspace and commercially available. The application takes the user through daily guided mindfulness meditations lasting approximately 10 minutes each, for 60 days. Participants will be asked to complete one guided-meditation exercise per day during the day time, and will be explicitly instructed to not use the application as a method to fall asleep. For the first 30 days of the intervention, participants will learn basic mindfulness skills. For the next 30 days, participants will undertake an extension of mindfulness skills designed specifically for the area of improving sleep. Data on app usage (e.g. amount of time per day, number of days per week) will be remotely recorded by Headspace.

Sponsors

RMIT University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1) Self-reported difficulties in any of the three core symptoms of insomnia:: difficulties initiating sleep, difficulties maintaining sleep, or early morning awakenings with an inability to return to sleep (a score of 8 or higher on the Insomnia Severity Index). 2) 18 years or over 3) Access to a smartphone device, as the intervention will be delivered via a smartphone application.

Exclusion criteria

1) Psychiatric or neurological impairment as this may influence their results on cognitive assessments. 3) Poor English-language ability. 4) Regular users of mindfulness-based mobile applications or those who regularly practice mindfulness. 5) High levels of depression as measured by a cut off score of 16 on the Center for Epidemiologic Studies Depression Scale (CES-D) or high levels of psychological distress as measured on the DASS-21. 6) Untreated sleep disorders with a medical cause (obstructive sleep apnea, restless leg syndrome). 7) Shift workers

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026