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Trial registered on ANZCTR


Registration number
ACTRN12612001177842
Ethics application status
Approved
Date submitted
2/11/2012
Date registered
6/11/2012
Date last updated
2/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The SENSE Study (Sleep and Education: learning New Skills Early)
Scientific title
In an at-risk cohort of early-to-mid adolescents, is a brief sleep intervention (Sleep SENSE) more effective than a study skills intervention (Study SENSE) in improving sleep and cardiovascular health and preventing the onset of depression at two-year follow up?
Secondary ID [1] 280802 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
The SENSE Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 286863 0
Cardiovascular disease 286864 0
Sleep 286865 0
Condition category
Condition code
Mental Health 287187 287187 0 0
Depression
Cardiovascular 287188 287188 0 0
Normal development and function of the cardiovascular system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The sleep intervention (Sleep SENSE) is a group intervention run over seven weekly sessions of 1.5 hours duration. The groups will include no more than 12 participants and will be led by two researchers, one of whom will be a registered clinical psychologist. Quarterly ‘booster’ sessions will be offered for participants to revise components of the interventions and ask any questions for two years following the intervention.

A summary of the Sleep SENSE session content is as follows:
Session 1. Introduction: education about sleep, developing motivation to change.
Session 2. Good sleep habits and overcoming barriers to sleep.
Session 3. Establishing a regular schedule for sleep and media use at bedtime.
Session 4. Mindfulness: Techniques for managing stress and improving sleep.
Session 5. Positive Thinking: Managing worries and unhelpful beliefs about sleep.
Session 6. Managing worries.
Session 7. Your sleep into the future.
Intervention code [1] 285233 0
Prevention
Intervention code [2] 285234 0
Lifestyle
Intervention code [3] 285235 0
Behaviour
Comparator / control treatment
The study intervention (Study SENSE) is a group intervention run over seven weekly sessions of 1.5 hours duration. The groups will include no more than 12 participants and will be led by two researchers, one of whom will have extensive expertise in the delivery of educational programs. Quarterly ‘booster’ sessions will be offered for participants to revise components of the interventions and ask any questions for two years following the intervention.

A summary of the Study SENSE session content is as follows:
Session 1. Introduction: Why study skills and habits are important for academic success.
Session 2. Personal organisation, time management and the home study environment.
Session 3. Active listening, learning, and note-taking strategies.
Session 4. Memory, memorisation techniques, and different ways of learning.
Session 5. Test-taking and essay writing strategies.
Session 6. Public speaking and presenting.
Session 7. Review of Study SENSE program and problem solving strategies.
Control group
Active

Outcomes
Primary outcome [1] 287481 0
Onset of Major Depressive Disorder assessed using the revised Schedule for Affective Disorders and Schizophrenia for School Aged Children, Present and Lifetime version, 2009 (K-SADS-PL)
Timepoint [1] 287481 0
Pre-intervention, post-intervention and 2-year follow-up
Secondary outcome [1] 298260 0
Sleep improvement assessed using subjective self-report measures: Pittsburgh Sleep Quality Index (PSQI) and a sleep diary. Sleep improvement assessed using objective measures: actigraphy and, in a subsample of participants, polysomnography (PSG) measures.
Timepoint [1] 298260 0
Pre-intervention, post-intervention and 2-year follow-up
Secondary outcome [2] 298261 0
Cardiovascular health determined by the disturbance of cardiac autonomic tone. This will be assessed by measuring heart rate using ECG and blood pressure using an arterial volume clamp method (Portapres Model 2, TNO-TPD, Biomedical Instrumentation, Amsterdam, The
Netherlands).
Timepoint [2] 298261 0
Pre-intervention and 2-year follow-up
Secondary outcome [3] 299849 0
Cardiovascular health determined by arterial stiffness. This will be measured by a standard measure of endothelial function, the arterial dilatation response to the release of brachial artery occlusion. The dilation response will be measured by peripheral arterial tonometry (Endo-PAT2000, Itamar Medical, Israel).
Timepoint [3] 299849 0
Pre-intervention and 2-year follow-up
Secondary outcome [4] 299850 0
Cardiovascular health detremined by immune system and platelet activation and cytokine, glucose and oxidized LDL levels. This will be assessed by taking blood and saliva samples.
Timepoint [4] 299850 0
Pre-intervention and 2-year follow-up

Eligibility
Key inclusion criteria
Self-reported sleeping difficulties using the Pittsburgh Sleep Quality Index (PSQI) and self-reported anxiety symptoms using the Spence Children's Anxiety Scale (SCAS).
Minimum age
12 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
A history of Major Depressive Disorder, bipolar or psychotic disorders prior to entry into the study.
A history of significant head injury/ies
Inadequate comprehension of English.

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)
Subjects will be enrolled following completion of the pre-intervention assessments (diagnostic interview to ensure they meet inclusion/exclusion criteria, cardiovascular assessment and sleep assessment)
Treatment allocation will be concealed and done by computerised central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by gender and the randomisation sequence will be generated using a
minimisation method available in the MINIM computer program.
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
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

Funding & Sponsors
Funding source category [1] 285604 0
Government body
Name [1] 285604 0
National Health and Medical Research Council
Address [1] 285604 0
Level 1, 16 Marcus Clarke Street (GPO Box 1421)
Canberra ACT 2601
Country [1] 285604 0
Australia
Funding source category [2] 285691 0
University
Name [2] 285691 0
University of Melbourne
Address [2] 285691 0
Melbourne School of Psychological Sciences
Redmond Barry Building
Tin Alley
University of Melbourne
Parkville, VIC 3010
Country [2] 285691 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Melbourne School of Psychological Sciences
Redmond Barry Building
Tin Alley
University of Melbourne
Parkville, VIC 3010
Country
Australia
Secondary sponsor category [1] 284519 0
None
Name [1] 284519 0
Address [1] 284519 0
Country [1] 284519 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287603 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 287603 0
Melbourne Research
161 Barry St (Cnr. Grattan St)
Level 5, Alan Gilbert Building
The Univerity of Melbourne
Carlton, VIC 3010
Ethics committee country [1] 287603 0
Australia
Date submitted for ethics approval [1] 287603 0
Approval date [1] 287603 0
19/06/2012
Ethics approval number [1] 287603 0
1237312

Summary
Brief summary
Adolescent depression is both common and harmful, with an estimated 15-20% of adolescents experiencing clinical depression. Depression is strongly associated with disturbed sleep, a relationship that is particularly marked in adolescence. There is accumulating evidence that disturbed sleep can play a precipitating role in the onset of depression, which suggests that treatment of disturbed sleep might improve resilience against the development of depression. However, efforts to clinically target disturbed sleep as a critical mechanism in treatment or prevention are still in their infancy.
Improved sleep can also be expected to benefit cardiovascular health. There is a complex relationship between depression, sleep and cardiovascular disease (CVD) across the lifespan, suggesting that early intervention for sleep may impact on a mechanism jointly associated with risk for CVD and depression.
Aim:
1. To deliver a brief sleep intervention to adolescents who are experiencing both anxiety symptoms and sleep disturbance with the aim of preventing the onset of depression and improving cardiovascular health.
Research Questions:
1. Can a brief sleep intervention:
a. Improve both subjective and objective indices of sleep quality in at-risk adolescents, and will this improvement persist at two-year follow-up?
b. Decrease reports of anxiety and mood symptoms, and prevent the onset of case level depression over a two year follow-up period in at-risk adolescents?
c. Improve indices of adolescent cardiovascular health at two-year follow-up?
2. Are benefits to both mental and cardiovascular health mediated by measured improvements in sleep that result from the sleep intervention?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34413 0
Prof Professor Nick Allen
Address 34413 0
Ann Swindells Professor of Clinical Psychology
Department of Psychology
University of Oregon
Eugene OR 97403-1227
Country 34413 0
United States of America
Phone 34413 0
+1 541 346 4075
Fax 34413 0
Email 34413 0
nallen3@uoregon.edu
Contact person for public queries
Name 17660 0
Prof Professor Nicholas Allen
Address 17660 0
Ann Swindells Professor of Clinical Psychology
Department of Psychology
University of Oregon
Eugene OR 97403-1227
Country 17660 0
United States of America
Phone 17660 0
+1 541 346 4075
Fax 17660 0
Email 17660 0
nallen3@uoregon.edu
Contact person for scientific queries
Name 8588 0
Prof Professor Nicholas Allen
Address 8588 0
Ann Swindells Professor of Clinical Psychology
Department of Psychology
University of Oregon
Eugene OR 97403-1227
Country 8588 0
United States of America
Phone 8588 0
+1 541 346 4075
Fax 8588 0
Email 8588 0
nallen3@uoregon.edu

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