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Trial Review
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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 information initially 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
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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
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Secondary ID [1]
253519
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This trial is registered with The Australian National University Human Reseach Ethics Committee (2011/041).
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Universal Trial Number (UTN)
U1111-1119-2548
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Trial acronym
SHUTi
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major depressive disorder
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Depression
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Insomnia
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Condition category
Condition code
Mental Health
259219
259219
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0
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Depression
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Mental Health
259220
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
257948
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Prevention
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
257951
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Reduction of depression symptoms at immediate posttest (and then 6-month, 12-month and 18-month follow-up), as measured using the PHQ-9.
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Assessment method [1]
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Timepoint [1]
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Immediate Posttest (and then 6-month, 12-month and 18-month follow-up)
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Secondary outcome [1]
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Diagnosis of generalised anxiety disorder (MINI)
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Assessment method [1]
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Timepoint [1]
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Immediate post-test; 12-month follow-up
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Secondary outcome [2]
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Diagnosis of panic disorder (MINI)
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Assessment method [2]
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Timepoint [2]
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Immediate post-test; 12-month follow-up
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Secondary outcome [3]
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Diagnosis of social anxiety disorder (MINI)
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Assessment method [3]
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Timepoint [3]
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Immediate post-test; 12-month follow-up
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Secondary outcome [4]
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Cognition/speed (BTACT)
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Assessment method [4]
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Timepoint [4]
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Immediate post-test; 12-month follow-up
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Secondary outcome [5]
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Insomnia (ISI)
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Assessment method [5]
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Timepoint [5]
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Screening, baseline, every two weeks during active intervention phase (2, 4, 6, 8 weeks), posttest, 6-, 12- and 18-month follow-ups.
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Secondary outcome [6]
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Disability (WHODAS12/hours worked per day)
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Assessment method [6]
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Timepoint [6]
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Screening, posttest, 6-month follow-up, 12-month follow-up, 18-month follow-up.
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Secondary outcome [7]
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Help-seeking intentions (GHSQ)
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Assessment method [7]
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Timepoint [7]
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Screening, posttest, 6-month follow-up, 12-month follow-up, 18-month follow-up.
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Secondary outcome [8]
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Help-seeking behaviour (AHSQ)
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Assessment method [8]
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Timepoint [8]
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Screening, posttest, 6-month follow-up, 12-month follow-up, 18-month follow-up.
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Secondary outcome [9]
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Reasons for dropout/satisfaction (Ritterband, IEUQ, IIEQ)
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Assessment method [9]
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Timepoint [9]
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Posttest
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Secondary outcome [10]
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Anxiety symptoms (GAD-7 scale)
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Assessment method [10]
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Timepoint [10]
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Baseline, every two weeks during active intervention phase (weeks 2, 4, 6, 8), posttest, 6-, 12-, and 18-month follow-ups.
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Secondary outcome [11]
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Suicidal Ideation (from PSF)
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Assessment method [11]
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Timepoint [11]
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Baseline, posttest, 6-, 12-, and 18-month follow-ups.
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Secondary outcome [12]
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Dysfunctional Beliefs about Sleep
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Assessment method [12]
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Timepoint [12]
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Baseline, posttest, 6-, 12-, and 18-month follow-ups.
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Secondary outcome [13]
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Sleep-associated monitoring. This will be assessed using the brief version of the SAMI (Sleep-Associated Monitoring Index).
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Assessment method [13]
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Timepoint [13]
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Baseline, posttest, 6-, 12-, and 18-month follow-ups.
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Secondary outcome [14]
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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.
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Assessment method [14]
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Timepoint [14]
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Baseline, posttest, 6-, 12-, and 18-month follow-ups.
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Secondary outcome [15]
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Physical activity (IPAQ-SF)
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Assessment method [15]
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Timepoint [15]
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Baseline, posttest, 6-, 12-, and 18-month follow-ups.
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Secondary outcome [16]
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Health service usage (measured through self report and through actual health data)
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Assessment method [16]
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Timepoint [16]
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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.
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Secondary outcome [17]
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Diagnosis of Major Depressive Disorder on MINI International Neuropsychiatric Interview
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Assessment method [17]
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Timepoint [17]
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Immediate Posttest; 12-month follow-up
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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.
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation will be carried out using automated computer-based randomisation procedures.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/04/2012
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Actual
11/04/2013
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Date of last participant enrolment
Anticipated
1/07/2014
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Actual
9/06/2014
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Date of last data collection
Anticipated
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Actual
18/09/2015
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Sample size
Target
1600
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Accrual to date
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Final
1149
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council
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Address [1]
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National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Professor Helen Christensen
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Address
Black Dog Institute,
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Professor Kathleen Griffiths
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Address [1]
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Centre for Mental Health Research
ANU College of Medicine, Biology & Environment
Building 63 Eggleston Road
Canberra ACT 0200 Australia
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Country [1]
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Professor Jim Butler
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Address [1]
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Australian Centre for Economic Research on Health
ANU College of Medicine, Biology and Environment
Building 62
cnr Mills & Eggleston Roads
Acton ACT 2600
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Country [1]
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Ms Kylie Bennett
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Address [2]
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Centre for Mental Health Research
ANU College of Medicine, Biology & Environment
Building 63 Eggleston Road
Canberra ACT 0200 Australia
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Country [2]
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
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Mr Anthony Bennett
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Address [3]
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Centre for Mental Health Research
ANU College of Medicine, Biology & Environment
Building 63 Eggleston Road
Canberra ACT 0200 Australia
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Country [3]
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Australia
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Other collaborator category [4]
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Individual
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Name [4]
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Associate Professor Nick Glozier
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Address [4]
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Brain and Mind Research Institute,
100 Mallett Street
Camperdown 2050
Sydney NSW
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Country [4]
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Australia
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Other collaborator category [5]
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Individual
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Name [5]
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Professor Andrew Mackinnon
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Address [5]
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Orygen Research Centre
University of Melbourne
35 Poplar Rd
Parkville VIC 3052
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Country [5]
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Australia
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Other collaborator category [6]
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Individual
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Name [6]
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Professor Ian Hickie
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Address [6]
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Brain and Mind Research Institute,
100 Mallett Street
Camperdown 2050
Sydney NSW
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Country [6]
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Australia
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Other collaborator category [7]
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Individual
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Name [7]
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Dr Lee Ritterband
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Address [7]
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Behavioral Health and Technology Department of Psychiatry and Neurobehavioral Sciences
University of Virginia Health System
310 Old Ivy Way,
Suite 102
Charlottesville 22903
Virginia
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Country [7]
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United States of America
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Other collaborator category [8]
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Individual
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Name [8]
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Dr Francis Thorndike
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Address [8]
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Behavioral Health and Technology Department of Psychiatry and Neurobehavioral Sciences
University of Virginia Health System
310 Old Ivy Way,
Suite 102
Charlottesville 22903
Virginia
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Country [8]
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United States of America
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Australian National University Human Research Ethics Committee
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Ethics committee address [1]
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Research Office
Lower Ground Floor
Chancelry 10B
East Road
Australian National University
Acton ACT 0200
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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31/01/2011
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Approval date [1]
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25/02/2011
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Ethics approval number [1]
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2011/041
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Summary
Brief summary
This project investigates the efficacy of a novel internet-based insomnia treatment program (SHUTi) as a prevention tool for Major Depressive Disorder.
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Trial website
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Trial related presentations / publications
Gosling, J. A., Glozier, N., Griffiths, K., Ritterband, L., Thorndike, F., Mackinnon, A., ... & Christensen, H. (2014). The GoodNight study—online CBT for insomnia for the indicated prevention of depression: study protocol for a randomised controlled trial. Trials, 15(1), 56.
Christensen, H., Batterham, P. J., Gosling, J. A., Ritterband, L. M., Griffiths, K. M., Thorndike, F. P., ... & Mackinnon, A. J. (2016). Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): a randomised controlled trial. The Lancet Psychiatry, 3(4), 333-341.
Gosling, J. A., Batterham, P., Ritterband, L., Glozier, N., Thorndike, F., Griffiths, K. M., ... & Christensen, H. M. (2018). Online insomnia treatment and the reduction of anxiety symptoms as a secondary outcome in a randomised controlled trial: The role of cognitive-behavioural factors. Australian & New Zealand Journal of Psychiatry, 0004867418772338.
Batterham, P. J., Christensen, H., Mackinnon, A. J., Gosling, J. A., Thorndike, F. P., Ritterband, L. M., ... & Griffiths, K. M. (2017). Trajectories of change and long-term outcomes in a randomised controlled trial of internet-based insomnia treatment to prevent depression. BJPsych Open, 3(5), 228-235.
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Public notes
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Contacts
Principal investigator
Name
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Prof Helen Christensen
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Address
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Black Dog Institute, Hospital Road Prince of Wales Hospital Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9382 9288
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Prof Professor Helen Christensen
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Address
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Black Dog Institute,
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
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Country
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Australia
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Phone
15400
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+61 2 9382 9288
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Fax
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+61 2 9382 8208
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Professor Helen Christensen
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Address
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Black Dog Institute,
Hospital Road
Prince of Wales Hospital
Randwick NSW 2031
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Country
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Australia
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Phone
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+61 2 9382 9288
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Fax
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+61 2 9382 8208
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Yes; IPD and related data dictionaries are/will be available
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When will data be available (start and end dates)?
From 26/6/2023
End unknown
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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)
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Available for what types of analyses?
Any type of analysis
Assessed on a case-by-case basis
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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
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
19716
Study protocol
https://doi.org/10.1186/1745-6215-15-56
19717
Data dictionary
https://doi.org/10.5281/zenodo.8084715
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
https://doi.org/10.1016/S2215-0366(15)00536-2 ...
[
More Details
]
336475-(Uploaded-28-06-2023-10-48-56)-Journal results publication.pdf
Study results article
Yes
https://doi.org/10.1192/bjpo.bp.117.005231
336475-(Uploaded-28-06-2023-10-48-18)-Journal results publication.pdf
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
The GoodNight study-online CBT for insomnia for the indicated prevention of depression: Study protocol for a randomised controlled trial.
2014
https://dx.doi.org/10.1186/1745-6215-15-56
Embase
Effectiveness of an online insomnia program (SHUTi) for prevention of depressive episodes (the GoodNight Study): A randomised controlled trial.
2016
https://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.
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