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Trial registered on ANZCTR


Registration number
ACTRN12613001266752
Ethics application status
Approved
Date submitted
14/11/2013
Date registered
18/11/2013
Date last updated
22/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
An Australian designed, online cognitive behavioural therapy intervention for insomnia: an open trial
Scientific title
Evaluation of insomnia severity amongst a group of public insomnia clinic patients after an online cognitive behavioural therapy intervention, Sleep-e.
Secondary ID [1] 283523 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 290442 0
Condition category
Condition code
Mental Health 290830 290830 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] 288225 0
Behaviour
Intervention code [2] 288296 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] 290825 0
Insomnia severity, as measured by the Insomnia Severity Index (ISI)
Timepoint [1] 290825 0
Participants will complete the ISI at pre program (0 weeks), mid program(weeks 4-5), and post program (weeks 7-9)
Secondary outcome [1] 305383 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] 305383 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 (so they will complete the sleep diary for 9 weeks in total).
Secondary outcome [2] 305384 0
Dysfunctional sleep related beliefs, as measured by the Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS-16)
Timepoint [2] 305384 0
Participants will complete these questionnaires at pre program (0 weeks), mid program (weeks 4-5), and post program (weeks 7-9)
Secondary outcome [3] 305544 0
Daily activity, light exposure, and sleep quality as measured objectively by actigraphy
Timepoint [3] 305544 0
Participants will wear actigraph watches for 2 weeks at pre program (weeks 0-2) and post program (weeks 7-9)
Secondary outcome [4] 305547 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 [4] 305547 0
Participants will complete the DASS-21 at pre program (0 weeks), mid program(weeks 4-5), and post program (weeks 7-9)
Secondary outcome [5] 305550 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 [5] 305550 0
Participants will complete the DASS-21 at pre program (0 weeks), mid program(weeks 4-5), and post program (weeks 7-9)
Secondary outcome [6] 305551 0
Symptoms of depression, such as feeling down and blue as measured by Depression Anxiety Stress Scales (DASS-21)
Timepoint [6] 305551 0
Participants will complete the DASS-21 at pre program (0 weeks), mid program (weeks 4-5), and post program (weeks 7-9)
Secondary outcome [7] 305552 0
Program satisfaction as measured by an online survey developed for this study, the Intervention Evaluation Questionnaire
Timepoint [7] 305552 0
Completed post program

Eligibility
Key inclusion criteria
a)Clinical or subclinical symptoms of Insomnia (Insomnia Severity Index score greater than or equal to 8)
b)Over 18 years of age
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+ 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)
Participants will be recruited via the waiting list for the Insomnia Clinic at Austin Health. Upon referral to the clinic, participants aged 18 years or older with referral information suggesting insomnia-related sleep difficulties will be contacted by a researcher. Paper based referrals will be accessed which contain information on the referral reason, referrer details participant age and the participants’ contact details. The referrals will also be checked on Austin Health’s electronic records of Medtrack and Scanned Medical Record, to assist the research team to identify appropriate referrals before contact is made. Participants will be given information about the study over the phone, and if they are interested in participating in the study they are asked for initial verbal consent, which will be followed up with posting them out the PICF and getting participants to return a signed consent form by post. On the telephone consenting participants will be given a website URL where they can read the full PICF. The PICF will explain that their clicking on the “start” button will be taken as their consenting to take part in the study, but that they will also be asked to return a signed consent form by post. They will be informed that they can leave the website and not return the hard copy consent form if they do not consent. If they consent they will be taken through 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). As the waiting list to see the clinic psychologist is approximately two to three months, participants will complete the Sleep-e program prior to their first appointment at the Insomnia Clinic.
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 using Repeated Measures (Within Subjects) ANOVAs and MANOVAs. If significant results are found, pair wise comparisons from pre- to post-assessment will be conducted.

Recruitment
Recruitment status
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)
VIC
Recruitment hospital [1] 1660 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 7540 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 288221 0
University
Name [1] 288221 0
National eTherapy Centre, Swinburne University of Technology
Address [1] 288221 0
H99
PO Box 218
Hawthorn
VIC 3122
Country [1] 288221 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] 286944 0
None
Name [1] 286944 0
Address [1] 286944 0
Country [1] 286944 0
Other collaborator category [1] 277688 0
Hospital
Name [1] 277688 0
Insomnia Clinic, Heidelberg Repatriation Hospital, Austin Health
Address [1] 277688 0
300 Waterdale Road,
PO Box 5444
Heidelberg West
Victoria
Australia 3081
Country [1] 277688 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290130 0
Austin Health
Ethics committee address [1] 290130 0
Office for Research
Level 6 HSB
Austin Health
Studley Rd
Heidelberg 3084 Vic
Ethics committee country [1] 290130 0
Australia
Date submitted for ethics approval [1] 290130 0
Approval date [1] 290130 0
03/10/2013
Ethics approval number [1] 290130 0
H2013/05080
Ethics committee name [2] 290131 0
Swinburne University of Technology
Ethics committee address [2] 290131 0
PO Box 218
Hawthorn
VIC 3122
Ethics committee country [2] 290131 0
Australia
Date submitted for ethics approval [2] 290131 0
Approval date [2] 290131 0
08/10/2013
Ethics approval number [2] 290131 0
SUHREC 2013/216

Summary
Brief summary
The aim of this study is to investigate the effectiveness of an Australian-designed online cognitive behavioural therapy intervention for insomnia called Sleep-e. Insomnia is a very common sleep problem but many people do not access available treatment. Interventions that are delivered via the internet, such as Sleep-e, can increase the communities’ access to treatment, and improve health outcomes. Participants who are on the waiting list for the Insomnia Clinic at the Heidelberg Repatriation Hospital at Austin Health will be invited to take part in the study. Participants will initially complete a range of questionnaires via the internet about their sleep, and also complete sleep diaries and wear a wrist actigraph watch outlining their current sleep patterns. Participants will then complete 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. After the program has been completed, participants will be given questionnaires, sleep diaries and the wrist actigraph watch to re-assess their sleep. The time commitment for the program is approximately 1 hour per week over a 9 week period. Upon completion of the program, participants will have their appointment with the Insomnia Clinic.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44002 0
Dr Jo Abbott
Address 44002 0
Swinburne University of Technology
H99, PO Box 218,
Hawthorn, VIC, 3122
Country 44002 0
Australia
Phone 44002 0
+61 (03) 9214 5866
Fax 44002 0
Email 44002 0
jmabbott@swin.edu.au
Contact person for public queries
Name 44003 0
Dr Jo Abbott
Address 44003 0
Swinburne University of Technology
H99, PO Box 218,
Hawthorn, VIC, 3122
Country 44003 0
Australia
Phone 44003 0
+61 (03) 9214 5866
Fax 44003 0
Email 44003 0
jmabbott@swin.edu.au
Contact person for scientific queries
Name 44004 0
Dr Jo Abbott
Address 44004 0
Swinburne University of Technology
H99, PO Box 218,
Hawthorn, VIC, 3122
Country 44004 0
Australia
Phone 44004 0
+61 (03) 9214 5866
Fax 44004 0
Email 44004 0
jmabbott@swin.edu.au

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