Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000061538
Ethics application status
Approved
Date submitted
21/11/2014
Date registered
23/01/2015
Date last updated
17/04/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of constructive worry and mindfulness body scan for helping adolescent sleep
Scientific title
The use of constructive worry or mindfulness body scan compared to bedtime as normal, for helping adolescents' sleep.
Secondary ID [1] 285715 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 293587 0
Condition category
Condition code
Mental Health 293872 293872 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Constructive worry: 15 minutes per evening, between the hours of 6-8pm, of documenting worries/concerns, followed by ways to resolve these. Daily for two weeks.
Mindfulness body scan: 15 minutes of practicing a mindfulness body scan at normal bedtime, each day for two weeks.

Both groups will be given instructions immediately after completion of their baseline data, via the computer screen. The researcher will be present at the time, to answer any questions.

Adherence will be monitored by a twice-off self-report questionnaire.
Intervention code [1] 290668 0
Behaviour
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 293659 0
Sleep onset latency, measured by a self-report questionnaire, based on the School Sleep Habits Survey (Wolfson & Carskadon, 1998).
Timepoint [1] 293659 0
Baseline, one and two weeks after randomisation.
Primary outcome [2] 293660 0
Pre-sleep cognitive and emotional arousal. Measured by the Pre-sleep Arousal Scale and the Adolescent Sleep Hygiene Scale- revised.
Timepoint [2] 293660 0
Baseline, one and two weeks post randomisation.
Primary outcome [3] 293702 0
Total sleep time, measured by a self-report questionnaire, based on the School Sleep Habits Survey (Wolfson & Carskadon, 1998).
Timepoint [3] 293702 0
Baseline, one and two weeks post randomisation.
Secondary outcome [1] 311528 0
Daytime functioning. Measure by the Chronic Sleep Reduction Questionnaire - short form.
Timepoint [1] 311528 0
Baseline, one and two weeks post randomisation.

Eligibility
Key inclusion criteria
Over 14 years of age, attending high school.
Minimum age
14 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking medication that interferes with sleep. Currently attending treatment for a sleep disorder or anxiety.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Secondary schools in Adelaide will be contacted via email with details of the project. Schools who are interested can contact the researcher, to set up an initial information session with class(es), selected by the school (minimum Grade 10).

Classes will be randomly allocated to one of three conditions, but all students within a class will receive the same condition.

Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation (based on year level at school). A website will be used to randomly allocate classes to a group (https://www.sealedenvelope.com/simple-randomiser/v1/lists), prior to data collection.
Masking / blinding
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
27/01/2015
Actual
26/05/2015
Date of last participant enrolment
Anticipated
Actual
24/03/2016
Date of last data collection
Anticipated
Actual
6/04/2016
Sample size
Target
300
Accrual to date
Final
232
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 290288 0
University
Name [1] 290288 0
Flinders University
Country [1] 290288 0
Australia
Primary sponsor type
Individual
Name
Kate Bartel
Address
School of Psychology
Flinders University
GPO Box 2100
Adelaide
South Australia 5001
Country
Australia
Secondary sponsor category [1] 289001 0
Individual
Name [1] 289001 0
A/Prof Michael Gradisar
Address [1] 289001 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide
South Australia 5001
Country [1] 289001 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291998 0
Social and Behavioural Research Ethics Committee
Ethics committee address [1] 291998 0
Ethics committee country [1] 291998 0
Australia
Date submitted for ethics approval [1] 291998 0
19/01/2015
Approval date [1] 291998 0
01/04/2015
Ethics approval number [1] 291998 0

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

Contacts
Principal investigator
Name 52970 0
Prof Michael Gradisar
Address 52970 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide
SA 5001
Country 52970 0
Australia
Phone 52970 0
+61 8 82012324
Fax 52970 0
Email 52970 0
[email protected]
Contact person for public queries
Name 52971 0
Kate Bartel
Address 52971 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide
SA 5001
Country 52971 0
Australia
Phone 52971 0
+61 8 8201 3435
Fax 52971 0
Email 52971 0
[email protected]
Contact person for scientific queries
Name 52972 0
Kate Bartel
Address 52972 0
School of Psychology
Flinders University
GPO Box 2100
Adelaide
SA 5001
Country 52972 0
Australia
Phone 52972 0
+61 8 8201 3435
Fax 52972 0
Email 52972 0
[email protected]

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
No additional documents have been identified.