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Trial registered on ANZCTR


Registration number
ACTRN12611000121965
Ethics application status
Approved
Date submitted
1/02/2011
Date registered
2/02/2011
Date last updated
17/07/2023
Date data sharing statement initially provided
17/07/2023
Date results provided
17/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Can depression be prevented by reducing insomnia? The Good Night Sleep Study
Scientific title
The effect of an internet-based insomnia treatment program on the prevention of major depressive disorder in community members with subclinical depressive symptoms
Secondary ID [1] 253519 0
This trial is registered with The Australian National University Human Reseach Ethics Committee (2011/041).
Universal Trial Number (UTN)
U1111-1119-2548
Trial acronym
SHUTi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder 261071 0
Depression 261072 0
Insomnia 261073 0
Condition category
Condition code
Mental Health 259219 259219 0 0
Depression
Mental Health 259220 259220 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Internet-based insomnia treatment program (SHUTi). SHUTi is an automated self-help program consisting of a 6 week program conducted over a window of 9 weeks. Participation in the intervention involves approximately 1-2 hours per week. At five points during the study, participants will be asked to keep track of their sleep through a diary for a two week period. This will occur prior to initiation of the active intervention phase, immediately following active intervention phase, and also at 6-, 12- and18-month followups. This sleep diary takes about 5 minutes each day to complete and enter online. Participants will also be contacted to complete online questionnaires at baseline, after the intervention period (9 weeks), and then at 6, 12 and 18 months. The program is based on cognitive behaviour therapy.
Intervention code [1] 257948 0
Prevention
Intervention code [2] 257950 0
Treatment: Other
Intervention code [3] 257951 0
Behaviour
Comparator / control treatment
Internet-delivered control condition (HealthWatch). HealthWatch requires participants to complete online open ended questions that probe health and social issues. It consists of a six part program delivered over nine weeks. Participation in the intervention involves approximately 1-2 hours per week. It delivers an online ‘package’ of educational material with information about general health risks.In this condition, participants will be asked to monitor their sleep, to read information about how to improve your general health, and then answer some questions that look at ways to change their lifestyle to improve health. It contains no specific mental health information.
Control group
Active

Outcomes
Primary outcome [1] 289361 0
Reduction of depression symptoms at immediate posttest (and then 6-month, 12-month and 18-month follow-up), as measured using the PHQ-9.
Timepoint [1] 289361 0
Immediate Posttest (and then 6-month, 12-month and 18-month follow-up)
Secondary outcome [1] 273046 0
Diagnosis of generalised anxiety disorder (MINI)
Timepoint [1] 273046 0
Immediate post-test; 12-month follow-up
Secondary outcome [2] 273047 0
Diagnosis of panic disorder (MINI)
Timepoint [2] 273047 0
Immediate post-test; 12-month follow-up
Secondary outcome [3] 273048 0
Diagnosis of social anxiety disorder (MINI)
Timepoint [3] 273048 0
Immediate post-test; 12-month follow-up
Secondary outcome [4] 273049 0
Cognition/speed (BTACT)
Timepoint [4] 273049 0
Immediate post-test; 12-month follow-up
Secondary outcome [5] 273051 0
Insomnia (ISI)
Timepoint [5] 273051 0
Screening, baseline, every two weeks during active intervention phase (2, 4, 6, 8 weeks), posttest, 6-, 12- and 18-month follow-ups.
Secondary outcome [6] 273052 0
Disability (WHODAS12/hours worked per day)
Timepoint [6] 273052 0
Screening, posttest, 6-month follow-up, 12-month follow-up, 18-month follow-up.
Secondary outcome [7] 273053 0
Help-seeking intentions (GHSQ)
Timepoint [7] 273053 0
Screening, posttest, 6-month follow-up, 12-month follow-up, 18-month follow-up.
Secondary outcome [8] 273054 0
Help-seeking behaviour (AHSQ)
Timepoint [8] 273054 0
Screening, posttest, 6-month follow-up, 12-month follow-up, 18-month follow-up.
Secondary outcome [9] 273056 0
Reasons for dropout/satisfaction (Ritterband, IEUQ, IIEQ)
Timepoint [9] 273056 0
Posttest
Secondary outcome [10] 296318 0
Anxiety symptoms (GAD-7 scale)
Timepoint [10] 296318 0
Baseline, every two weeks during active intervention phase (weeks 2, 4, 6, 8), posttest, 6-, 12-, and 18-month follow-ups.
Secondary outcome [11] 296319 0
Suicidal Ideation (from PSF)
Timepoint [11] 296319 0
Baseline, posttest, 6-, 12-, and 18-month follow-ups.
Secondary outcome [12] 296320 0
Dysfunctional Beliefs about Sleep
Timepoint [12] 296320 0
Baseline, posttest, 6-, 12-, and 18-month follow-ups.
Secondary outcome [13] 296322 0
Sleep-associated monitoring. This will be assessed using the brief version of the SAMI (Sleep-Associated Monitoring Index).
Timepoint [13] 296322 0
Baseline, posttest, 6-, 12-, and 18-month follow-ups.
Secondary outcome [14] 296323 0
Self-efficacy (both general and sleep-specific). This will be assessed using Charles Morin's measures of personal efficacy used in the original USA trials of the SHUTi web-based insomnia intervention being implemented in this trial.
Timepoint [14] 296323 0
Baseline, posttest, 6-, 12-, and 18-month follow-ups.
Secondary outcome [15] 296324 0
Physical activity (IPAQ-SF)
Timepoint [15] 296324 0
Baseline, posttest, 6-, 12-, and 18-month follow-ups.
Secondary outcome [16] 296325 0
Health service usage (measured through self report and through actual health data)
Timepoint [16] 296325 0
Self-report at baseline, posttest, 6-, 12-, and 18-month follow-ups.
Medical records data covering from 6 months prior to trial commencement through to final follow-up assessment, retrieved midway through trial and after final follow-up.
Secondary outcome [17] 302316 0
Diagnosis of Major Depressive Disorder on MINI International Neuropsychiatric Interview
Timepoint [17] 302316 0
Immediate Posttest; 12-month follow-up

Eligibility
Key inclusion criteria
On the Patient Health Questionnaire 9: a score between from 5 to 19, inclusive. On the Bergen Insomnia Scale: a score of 3 or above on at least one of the first four items and a score of 3 or above on at least one of the last two items. Age 18-64. Valid email address. Reliable internet access. Valid telephone number. Currently living in Australia. Proficiency with reading English.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of current (1 month) MDD; non-English speaking; reading difficulties; diagnosis of psychosis, schizophrenia or bipolar mood disorder by a psychiatrist; bedtime outside of 8pm-2am more than twice a week (not primarily due to insomnia); rising time outside of 4am-10am more than twice a week (not primarily due to insomnia); pregnancy at time of recruitment; current suicide plan/ high risk of suicide.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be carried out using automated computer-based randomisation procedures.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised using automatised computer software on the portal, stratified by severity of symptoms and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/04/2012
Actual
11/04/2013
Date of last participant enrolment
Anticipated
1/07/2014
Actual
9/06/2014
Date of last data collection
Anticipated
Actual
18/09/2015
Sample size
Target
1600
Accrual to date
Final
1149
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 258413 0
Government body
Name [1] 258413 0
National Health and Medical Research Council
Country [1] 258413 0
Australia
Primary sponsor type
Individual
Name
Professor Helen Christensen
Address
Black Dog Institute,
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 257564 0
Individual
Name [1] 257564 0
Professor Kathleen Griffiths
Address [1] 257564 0
Centre for Mental Health Research
ANU College of Medicine, Biology & Environment
Building 63 Eggleston Road
Canberra ACT 0200 Australia
Country [1] 257564 0
Australia
Other collaborator category [1] 251787 0
Individual
Name [1] 251787 0
Professor Jim Butler
Address [1] 251787 0
Australian Centre for Economic Research on Health
ANU College of Medicine, Biology and Environment
Building 62
cnr Mills & Eggleston Roads
Acton ACT 2600
Country [1] 251787 0
Australia
Other collaborator category [2] 251788 0
Individual
Name [2] 251788 0
Ms Kylie Bennett
Address [2] 251788 0
Centre for Mental Health Research
ANU College of Medicine, Biology & Environment
Building 63 Eggleston Road
Canberra ACT 0200 Australia
Country [2] 251788 0
Australia
Other collaborator category [3] 251789 0
Individual
Name [3] 251789 0
Mr Anthony Bennett
Address [3] 251789 0
Centre for Mental Health Research
ANU College of Medicine, Biology & Environment
Building 63 Eggleston Road
Canberra ACT 0200 Australia
Country [3] 251789 0
Australia
Other collaborator category [4] 251790 0
Individual
Name [4] 251790 0
Associate Professor Nick Glozier
Address [4] 251790 0
Brain and Mind Research Institute,
100 Mallett Street
Camperdown 2050
Sydney NSW
Country [4] 251790 0
Australia
Other collaborator category [5] 251791 0
Individual
Name [5] 251791 0
Professor Andrew Mackinnon
Address [5] 251791 0
Orygen Research Centre
University of Melbourne
35 Poplar Rd
Parkville VIC 3052
Country [5] 251791 0
Australia
Other collaborator category [6] 251792 0
Individual
Name [6] 251792 0
Professor Ian Hickie
Address [6] 251792 0
Brain and Mind Research Institute,
100 Mallett Street
Camperdown 2050
Sydney NSW
Country [6] 251792 0
Australia
Other collaborator category [7] 251793 0
Individual
Name [7] 251793 0
Dr Lee Ritterband
Address [7] 251793 0
Behavioral Health and Technology Department of Psychiatry and Neurobehavioral Sciences
University of Virginia Health System
310 Old Ivy Way,
Suite 102
Charlottesville 22903
Virginia
Country [7] 251793 0
United States of America
Other collaborator category [8] 251794 0
Individual
Name [8] 251794 0
Dr Francis Thorndike
Address [8] 251794 0
Behavioral Health and Technology Department of Psychiatry and Neurobehavioral Sciences
University of Virginia Health System
310 Old Ivy Way,
Suite 102
Charlottesville 22903
Virginia
Country [8] 251794 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260387 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 260387 0
Ethics committee country [1] 260387 0
Australia
Date submitted for ethics approval [1] 260387 0
31/01/2011
Approval date [1] 260387 0
25/02/2011
Ethics approval number [1] 260387 0
2011/041

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32153 0
Prof Helen Christensen
Address 32153 0
Black Dog Institute, Hospital Road Prince of Wales Hospital Randwick NSW 2031
Country 32153 0
Australia
Phone 32153 0
+61 2 9382 9288
Fax 32153 0
Email 32153 0
[email protected]
Contact person for public queries
Name 15400 0
Professor Helen Christensen
Address 15400 0
Black Dog Institute,
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 15400 0
Australia
Phone 15400 0
+61 2 9382 9288
Fax 15400 0
+61 2 9382 8208
Email 15400 0
[email protected]
Contact person for scientific queries
Name 6328 0
Professor Helen Christensen
Address 6328 0
Black Dog Institute,
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
Country 6328 0
Australia
Phone 6328 0
+61 2 9382 9288
Fax 6328 0
+61 2 9382 8208
Email 6328 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Yes; IPD and related data dictionaries are/will be available
When will data be available (start and end dates)?
From 26/6/2023
End unknown
Available to whom?
Data are potentially available to
Researchers from universities and not for profit organisations and other organisations
Based in any location
All data requests will be considered by the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see our data sharing policy https://www.unsw.edu.au/content/dam/pdfs/governance/policy/2022-01-policies/researchdatagovernancepolicy.pdf)
Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
How or where can data be obtained?
As of 1st July 2023, access can be requested via the Health Data Australia catalogue (https://www.researchdata.edu.au/health). Search for the ACTRN number in the catalogue to find datasets associated with this trial


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19716Study protocol https://doi.org/10.1186/1745-6215-15-56 
19717Data dictionary https://doi.org/10.5281/zenodo.8084715 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe GoodNight study-online CBT for insomnia for the indicated prevention of depression: Study protocol for a randomised controlled trial.2014https://dx.doi.org/10.1186/1745-6215-15-56
EmbaseEffectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): A randomised controlled trial.2016https://dx.doi.org/10.1016/S2215-0366%2815%2900536-2
N.B. These documents automatically identified may not have been verified by the study sponsor.