The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613001306707
Ethics application status
Approved
Date submitted
22/11/2013
Date registered
22/11/2013
Date last updated
22/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Sleep-e: an online treatment program for insomnia
Scientific title
Evaluation of insomnia severity amongst adults with insomnia related sleep difficulties after an online cognitive behavioural therapy intervention, Sleep-e.
Secondary ID [1] 283604 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 290526 0
Condition category
Condition code
Mental Health 290917 290917 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
An online cognitive behavioural therapy program for insomnia called Sleep-e. Sleep-e is a 7–week interactive CBT program for insomnia. It comprises 6 modules including psycho-education about sleep and insomnia (Module 1), stimulus control and sleep restriction (Module 2), sleep hygiene and relaxation (Module 3), cognitive restructuring (Module 4 and 5), and a relapse prevention module (Module 6).

Participants will be asked to complete the first module over two weeks and the remaining modules over one week each. The anticipated duration to complete each module is approximately one hour.

Strategies used to monitor adherence to the intervention will include online checking of completion of daily sleep entries, date last logged in, page of program last accessed and dates of completion of surveys.
Intervention code [1] 288293 0
Behaviour
Intervention code [2] 288297 0
Treatment: Other
Comparator / control treatment
There is no control group for this study as it is an open trial pilot design.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290904 0
Insomnia severity, as measured by the Insomnia Severity Index (ISI)
Timepoint [1] 290904 0
Participants will complete the ISI at pre program (0 weeks), mid program (weeks 4-5), post program (weeks 7-9), and at a 3 month follow up (weeks 21-23).
Secondary outcome [1] 305573 0
Symptoms of Insomnia such as difficulty falling or staying asleep, early morning waking, and feelings of unrefreshed sleep. This will be measured by the consensus sleep diary.
Timepoint [1] 305573 0
Participants will complete the consensus diary throughout the duration of the Sleep-e program (Week 0-7). Participants will also complete the sleep diary for an additional two weeks after completion of the program (Week 7-9), as well as at a 3 month follow up (weeks 21-23).
Secondary outcome [2] 305574 0
Dysfunctional sleep related beliefs, as measured by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Timepoint [2] 305574 0
Participants will complete this questionnaire at pre program (0 weeks), mid program (weeks 4-5), post program (weeks 7-9), and at a 3 month follow-up (weeks 21-23).
Secondary outcome [3] 305575 0
Symptoms of stress, such as difficulty winding down, over-reacting to situations and feeling agitated, as measured by Depression Anxiety Stress Scales (DASS-21)
Timepoint [3] 305575 0
Participants will complete the DASS-21 at pre program (0 weeks), mid program(weeks 4-5), post program (weeks 7-9), and at a 3 month follow-up (weeks 21-23).
Secondary outcome [4] 305576 0
Symptoms of anxiety, such as rapid breathing in the absence of physical exertion, trembling, and feelings of panic, as measured by Depression Anxiety Stress Scales (DASS-21)
Timepoint [4] 305576 0
Participants will complete the DASS-21 at pre program (0 weeks), mid program(weeks 4-5), post program (weeks 7-9), and at 3 months follow-up (weeks 21-23).
Secondary outcome [5] 305577 0
Symptoms of depression, such as feeling down and blue as measured by Depression Anxiety Stress Scales (DASS-21)
Timepoint [5] 305577 0
Participants will complete the DASS-21 at pre program (0 weeks), mid program (weeks 4-5), post program (weeks 7-9), and at 3 months follow-up (weeks 21-23).
Secondary outcome [6] 305578 0
Program satisfaction as measured by an online survey developed for this study, the Intervention Evaluation Questionnaire
Timepoint [6] 305578 0
Completed post program (weeks 7-9)

Eligibility
Key inclusion criteria
a)Clinical or subclinical symptoms of Insomnia (Insomnia Severity Index
score greater than or equal to 8)
b)18 years of age or older
c)Australian resident
d)Access to the internet
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a)Current psychological treatment for insomnia
b)Extremely severe levels of depression, as measured by the Depression
Anxiety and Stress Scales, DASS-21 (A score of 14 or more on the DASS-21)
c)No access to the internet
d)Not able to understand English
e)Under 18 years of age
f)Non-Australian resident

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The project will be advertised on the Mental Health Online website (formerly Anxiety Online) as well as other mental health websites. Clients interested in finding out more will be directed to a website where they can read the full Information Statement and Consent form, and if they wish to proceed, start the pre-assessment questionnaire. Participants will be given the option of contacting the Principal Investigator to ask questions before providing consent.
The Information Statement and Consent form will explain that their clicking on the “start” button will be taken as their consenting to take part in the study. They will be informed that they can leave the website if they do not consent. If they consent they will directed to complete the pre-assessment questionnaire (via online survey), which asks for their email address, basic demographic information and includes the study measures. Participants who meet all the inclusion criteria for the study will be emailed details of how to access the Sleep-e program (including the program URL, a username and their password).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
As this is an open trial evaluation of the program, no control group is being recruited and hence participants are not randomised.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The sample demographics, questionnaire findings and sleep diary data will be described using descriptive and summary statistics. The study will investigate treatment effects of the Sleep-e program from pre- to post-assessment to follow-up-assessment and pre to follow-up-assessment using Repeated Measures (Within Subjects) ANOVAs and MANOVAs. If significant results are found, pairwise comparisons from pre to post- to follow-up-assessment and pre to follow-up-assessment will be conducted.

Recruitment
Recruitment status
Not yet recruiting
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)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 288284 0
Charities/Societies/Foundations
Name [1] 288284 0
Barbara Dicker Brain Sciences Foundation
Address [1] 288284 0
PO Box 218
Hawthorn
VIC 3122
Country [1] 288284 0
Australia
Primary sponsor type
University
Name
National eTherapy Centre, Swinburne University of Technology
Address
H99
PO Box 218
Hawthorn
VIC 3122
Country
Australia
Secondary sponsor category [1] 287002 0
None
Name [1] 287002 0
Address [1] 287002 0
Country [1] 287002 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290179 0
Swinburne University of Technology
Ethics committee address [1] 290179 0
PO Box 218
Hawthorn
VIC 3122
Ethics committee country [1] 290179 0
Australia
Date submitted for ethics approval [1] 290179 0
Approval date [1] 290179 0
10/09/2013
Ethics approval number [1] 290179 0
SUHREC 2013/212

Summary
Brief summary
The aim of this project is to investigate the effectiveness of an Australian designed cognitive behavioural therapy intervention for insomnia called Sleep-e. Insomnia is a very common sleep problem but many people do not access available treatment. Online interventions that are delivered via the internet, such as Sleep-e, can increase the communities’ access to treatment, and improve health outcomes. 70 participants with insomnia related sleep difficulties will be recruited into the study. Participants will be recruited either through completing the e-PASS online assessment on www.mentalhealthonline.com or through advertisements on mental health websites such as beyondbue and Reconnexion. Participants will initially
complete a range of questionnaires via the internet about their sleep, and also complete sleep diaries outlining their current sleep patterns. Participants will then complete Sleep-e, a 7 week online program based on cognitive behavioural therapy for insomnia. Every week, participants
will be asked to read one module, complete homework activities based on the module, and also complete weekly sleep diaries. Participants will be given questionnaires and sleep diaries to re-assess their sleep and insomnia immediately after the program has been completed, as
well as three months following completion. Twenty participants will also be interviewed by telephone regarding their program experiences and satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44330 0
Dr Jo Abbott
Address 44330 0
Swinburne University of Technology H99, PO Box 218, Hawthorn, VIC, 3122
Country 44330 0
Australia
Phone 44330 0
+61 (03) 9214 5866
Fax 44330 0
Email 44330 0
jmabbott@swin.edu.au
Contact person for public queries
Name 44331 0
Dr Jo Abbott
Address 44331 0
Swinburne University of Technology H99, PO Box 218, Hawthorn, VIC, 3122
Country 44331 0
Australia
Phone 44331 0
+61 (03) 9214 5866
Fax 44331 0
Email 44331 0
jmabbott@swin.edu.au
Contact person for scientific queries
Name 44332 0
Dr Jo Abbott
Address 44332 0
Swinburne University of Technology H99, PO Box 218, Hawthorn, VIC, 3122
Country 44332 0
Australia
Phone 44332 0
+61 (03) 9214 5866
Fax 44332 0
Email 44332 0
jmabbott@swin.edu.au

No information has been provided regarding IPD availability
Summary results
No Results