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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]

Nil

Universal Trial Number (UTN)

Nil

Trial acronym

The SENSE Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Depression

Cardiovascular disease

Sleep

Condition category

Condition code

Mental Health

Depression

Cardiovascular

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

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]

Pre-intervention, post-intervention and 2-year follow-up

Secondary outcome [1]

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]

Pre-intervention, post-intervention and 2-year follow-up

Secondary outcome [2]

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]

Pre-intervention and 2-year follow-up

Secondary outcome [3]

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]

Pre-intervention and 2-year follow-up

Secondary outcome [4]

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]

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

Sex

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

1/09/2012

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

134

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1, 16 Marcus Clarke Street (GPO Box 1421)
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Melbourne

Address [2]

Melbourne School of Psychological Sciences
Redmond Barry Building
Tin Alley
University of Melbourne
Parkville, VIC 3010

Country [2]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Research Ethics Committee

Ethics committee address [1]

Melbourne Research
161 Barry St (Cnr. Grattan St)
Level 5, Alan Gilbert Building
The Univerity of Melbourne
Carlton, VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

19/06/2012

Ethics approval number [1]

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

Prof Professor Nick Allen

Address

Ann Swindells Professor of Clinical Psychology
Department of Psychology
University of Oregon
Eugene OR 97403-1227

Country

United States of America

Phone

+1 541 346 4075

Fax

nallen3@uoregon.edu

Contact person for public queries

Name

Professor Nicholas Allen

Address

Ann Swindells Professor of Clinical Psychology
Department of Psychology
University of Oregon
Eugene OR 97403-1227

Country

United States of America

Phone

+1 541 346 4075

Fax

nallen3@uoregon.edu

Contact person for scientific queries

Name

Professor Nicholas Allen

Address

Ann Swindells Professor of Clinical Psychology
Department of Psychology
University of Oregon
Eugene OR 97403-1227

Country

United States of America

Phone

+1 541 346 4075

Fax

nallen3@uoregon.edu

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The SENSE Study (Sleep and Education: learning New Skills Early): a community cognitive-behavioural therapy and mindfulness-based sleep intervention to prevent depression and improve cardiac health in adolescence.	2015	https://dx.doi.org/10.1186/s40359-015-0096-x
Embase	The SENSE Study: Post Intervention Effects of a Randomized Controlled Trial of a Cognitive-Behavioral and Mindfulness-Based Group Sleep Improvement Intervention among At-Risk Adolescents.	2016	https://dx.doi.org/10.1037/ccp0000142
Embase	A cognitive-behavioral and mindfulness-based group sleep intervention improves behavior problems in at-risk adolescents by improving perceived sleep quality.	2017	https://dx.doi.org/10.1016/j.brat.2017.10.006
Embase	Who benefits from adolescent sleep interventions? Moderators of treatment efficacy in a randomized controlled trial of a cognitive-behavioral and mindfulness-based group sleep intervention for at-risk adolescents.	2018	https://dx.doi.org/10.1111/jcpp.12842

N.B. These documents automatically identified may not have been verified by the study sponsor.

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