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Trial registered on ANZCTR


Registration number
ACTRN12616000605493
Ethics application status
Approved
Date submitted
20/04/2016
Date registered
10/05/2016
Date last updated
18/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Examining the effectiveness of two smartphone applications for improving symptoms of insomnia
Scientific title
Examining the effectiveness of two smartphone applications for improving symptoms of insomnia
Secondary ID [1] 289053 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 298486 0
Condition category
Condition code
Mental Health 298575 298575 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294541 0
Treatment: Devices
Intervention code [2] 294606 0
Lifestyle
Comparator / control treatment
Progressive muscle relaxation smartphone application. This application was developed specifically for research purposes as an active control program. The application takes the user through daily guided muscle relaxation lasting approximately 10 minutes each (e.g. "tense up your calf muscles, hold, and relax them as you breathe out"). Participants will be asked to complete one exercise per day during the day time, and will be explicitly instructed to not use the application as a method to fall asleep.
Control group
Active

Outcomes
Primary outcome [1] 298068 0
Change in Insomnia Severity Index score from baseline
Timepoint [1] 298068 0
baseline and 60 days after the intervention starts.
Primary outcome [2] 298069 0
Change in Depression Anxiety Stress Scales (DASS-21) score from baseline
Timepoint [2] 298069 0
baseline and 60 days after the intervention starts.
Secondary outcome [1] 323080 0
Five Facet Mindfulness Questionnaire Short Form change from baseline
Timepoint [1] 323080 0
baseline and 60 days after the intervention starts.
Secondary outcome [2] 323081 0
Metacognitions Questionnaire – Insomnia change from baseline
Timepoint [2] 323081 0
baseline and 60 days after the intervention starts.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
A mixed-design ANOVA will be conducted to determine the effects of mindfulness versus control before and after the intervention on self-reported and actigraphy-measured sleep, pre-sleep arousal, mood, cognitive functioning, trait mindfulness, mindfulness skills, and metacognitive beliefs. We plan to recruit 80 participants for the study, who will be followed up 60 days after commencing the intervention. Sample size is calculated assuming a Cohen’s d of 0.92 on total wake time (TWT) as measured by sleep diary over 8 weeks for MBT-I (Ong et al., 2014). G*Power analysis indicates that we need a total of 32 patients in each group to detect an effect size of 0.92, assuming beta = 0.80 and a = 0.05. We estimate 20% attrition; therefore we will recruit 40 participants in each group.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Time restraints for the students collecting the data for their research theses.
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 293429 0
University
Name [1] 293429 0
RMIT University
Address [1] 293429 0
Plenty Rd
Bundoora VIC 3083
Country [1] 293429 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Plenty Rd
Bundoora VIC 3083
Country
Australia
Secondary sponsor category [1] 292294 0
None
Name [1] 292294 0
Address [1] 292294 0
Country [1] 292294 0
Other collaborator category [1] 278980 0
Commercial sector/Industry
Name [1] 278980 0
Headspace
Address [1] 278980 0
Unit B-C, 7 Papermill Building
City Garden Row
London
N1 8DW
Country [1] 278980 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294873 0
RMIT University
Ethics committee address [1] 294873 0
RMIT University

GPO Box 2476

Building 91, Level 2

MELBOURNE VIC 3001
Ethics committee country [1] 294873 0
Australia
Date submitted for ethics approval [1] 294873 0
31/08/2015
Approval date [1] 294873 0
04/11/2015
Ethics approval number [1] 294873 0
19599

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65314 0
Dr Melinda Jackson
Address 65314 0
RMIT University
Plenty Rd
Bundoora VIC 3083
Country 65314 0
Australia
Phone 65314 0
+613 99257564
Fax 65314 0
Email 65314 0
melinda.jackson@rmit.edu.au
Contact person for public queries
Name 65315 0
Dr Melinda Jackson
Address 65315 0
RMIT University
Plenty Rd
Bundoora VIC 3083
Country 65315 0
Australia
Phone 65315 0
+613 99257564
Fax 65315 0
Email 65315 0
melinda.jackson@rmit.edu.au
Contact person for scientific queries
Name 65316 0
Dr Melinda Jackson
Address 65316 0
RMIT University
Plenty Rd
Bundoora VIC 3083
Country 65316 0
Australia
Phone 65316 0
+613 99257564
Fax 65316 0
Email 65316 0
melinda.jackson@rmit.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary