Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001041044
Ethics application status
Approved
Date submitted
23/11/2010
Date registered
26/11/2010
Date last updated
26/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of psychological therapy for adolescents with sleep disturbance.
Scientific title
A randomised controlled trial of cognitive-behaviour therapy for adolescents diagnosed with delayed sleep phase disorder: evaluation of sleep, sleepiness, and mood.
Secondary ID [1] 253148 0
This trial does not have a secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delayed Sleep Phase Disorder 258698 0
Condition category
Condition code
Mental Health 258850 258850 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive-behaviour therapy; six 50-min individual sessions over 8 weeks.
Cognitive-behaviour therapy involves education about sleep, sleep hygiene, evening dim light, morning bright light therapy, and cognitive therapy for insomnia.
Intervention code [1] 257653 0
Behaviour
Comparator / control treatment
Waitlist Control; no treatment for 8 weeks; afterwards provided with cognitive-behaviour therapy as per the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 259703 0
total sleep time; measured via self-reported 7-day sleep diary
Timepoint [1] 259703 0
total sleep time measured at pre-treatment, post-treatment, and 6-month follow-up.
Secondary outcome [1] 266422 0
sleep onset time; measured via self-reported 7-day sleep diary
Timepoint [1] 266422 0
sleep onset time measured at pre-treatment, post-treatment, and 6-month follow-up.

Eligibility
Key inclusion criteria
Sleep timing is significantly delayed relative to socially conventional times (eg, school start time), evidenced by a chronic inability to sleep and wake at desired times. May have associated insomnia and daytime sleepiness symptoms. Sleep disturbance significantly impacts on at least 1 important area of life (eg, school attendance/performance).
Minimum age
11 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Sleep disturbance is better explained by another sleep disorder (eg, insomnia, insomnia due to a mental disorder); atypical development (ie, diagnosed intellectual ability, autistic spectrum disorder); younger than 11 yrs and older than 18 yrs.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/07/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258120 0
Charities/Societies/Foundations
Name [1] 258120 0
Channel 7 Children's Research Foundation
Country [1] 258120 0
Australia
Funding source category [2] 258121 0
University
Name [2] 258121 0
Faculty of Social & Behavioural Sciences
Country [2] 258121 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Gradisar
Address
Flinders University
School of Psychology,
GPO Box 2100,
Adelaide, SA, 5001
Country
Australia
Secondary sponsor category [1] 257298 0
None
Name [1] 257298 0
Address [1] 257298 0
Country [1] 257298 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of the study is to evaluate cognitive-behaviour therapy (CBT) for adolescents with delayed sleep. It is hypothesised that CBT will result in more night-time sleep and fall asleep earlier.
Trial website
Trial related presentations / publications
Gradisar, M., Dohnt, H., Gardner, G., Paine, S., Starkey, K., Slater, A., Menne, A., Wright, H., Trenowden, S., & Hudson, J.L. A randomised controlled trial of cognitive behaviour therapy for adolescent Delayed Sleep Phase Disorder. Journal of Sleep Research, 19 (Suppl. 2), 31.
Public notes

Contacts
Principal investigator
Name 31945 0
Address 31945 0
Country 31945 0
Phone 31945 0
Fax 31945 0
Email 31945 0
Contact person for public queries
Name 15192 0
Dr Michael Gradisar
Address 15192 0
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 15192 0
Australia
Phone 15192 0
+61 8 8201 2324
Fax 15192 0
Email 15192 0
[email protected]
Contact person for scientific queries
Name 6120 0
Dr Michael Gradisar
Address 6120 0
Flinders University
GPO Box 2100
Adelaide, SA, 5001
Country 6120 0
Australia
Phone 6120 0
+61 8 8201 2324
Fax 6120 0
Email 6120 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.