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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Insomnia

Condition category

Condition code

Mental Health

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]

Treatment: Devices

Intervention code [2]

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]

Change in Insomnia Severity Index score from baseline

Timepoint [1]

baseline and 60 days after the intervention starts.

Primary outcome [2]

Change in Depression Anxiety Stress Scales (DASS-21) score from baseline

Timepoint [2]

baseline and 60 days after the intervention starts.

Secondary outcome [1]

Five Facet Mindfulness Questionnaire Short Form change from baseline

Timepoint [1]

baseline and 60 days after the intervention starts.

Secondary outcome [2]

Metacognitions Questionnaire – Insomnia change from baseline

Timepoint [2]

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

Sex

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

8/02/2016

Date of last participant enrolment

Anticipated

30/09/2016

Actual

8/08/2016

Date of last data collection

Anticipated

Actual

18/10/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

RMIT University

Address [1]

Plenty Rd
Bundoora VIC 3083

Country [1]

Australia

Primary sponsor type

University

Name

RMIT University

Address

Plenty Rd
Bundoora VIC 3083

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Headspace

Address [1]

Unit B-C, 7 Papermill Building
City Garden Row
London
N1 8DW

Country [1]

United Kingdom

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

RMIT University

Ethics committee address [1]

RMIT University

GPO Box 2476

Building 91, Level 2

MELBOURNE  VIC  3001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/08/2015

Approval date [1]

04/11/2015

Ethics approval number [1]

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

Dr Melinda Jackson

Address

RMIT University
Plenty Rd
Bundoora VIC 3083

Country

Australia

Phone

+613 99257564

Fax

[email protected]

Contact person for public queries

Name

Melinda Jackson

Address

RMIT University
Plenty Rd
Bundoora VIC 3083

Country

Australia

Phone

+613 99257564

Fax

[email protected]

Contact person for scientific queries

Name

Melinda Jackson

Address

RMIT University
Plenty Rd
Bundoora VIC 3083

Country

Australia

Phone

+613 99257564

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Treating subclinical and clinical symptoms of insomnia with a mindfulness-based smartphone application: A pilot study.	2020	https://dx.doi.org/10.1016/j.invent.2020.100335

N.B. These documents automatically identified may not have been verified by the study sponsor.

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