Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001024235
Ethics application status
Not yet submitted
Date submitted
23/11/2009
Date registered
25/11/2009
Date last updated
25/11/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A Group-based Cognitive-Behavioural intervention to treat sleep disorders that negatively impact mood, daily functioning and externalising behaviour in adolescents.
Scientific title
The effect of a group based cognitive behaviour therapy intervention on sleep quality and actigraphy in teenagers with sleep disorders
Universal Trial Number (UTN)
U1111-1112-6006
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sleep disorders 252260 0
Condition category
Condition code
Mental Health 252450 252450 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adolescents with sleep disorders will be randomly allocated to a 7-week Cognitive Behavioural Therapy (CBT) program for sleep disorders, or a 7-week no-treatment waitlist control condition. The treatment involves 4 structured 2hr group sessions administered by a psychologist or clinical psychologist. Session 1 focuses on rapport building, goal setting, and sleep psychoeducation. Session 2 focuses on changing sleep behaviour (stimulus control and sleep restriction). Session 3 focuses on changing negative thoughts, attitudes and beliefs about sleep. Session 4 aims to tailor the program to the individual, allow for problem solving and information about relapse prevention
Intervention code [1] 241593 0
Treatment: Other
Comparator / control treatment
Adolescents with sleep disorders will be randomly allocated to a 7-week Cognitive Behavioural Therapy program for sleep disorders, or a 7-week no-treatment waitlist control condition. Teenagers in the waitlist condition wait 7 weeks and repeat baseline assessments before beginning treatment.
Control group
Active

Outcomes
Primary outcome [1] 253322 0
Sleep as measured by Actigraphy data. Actigraphy will provide the primary objective measure of sleep/wake cycles. Participants will wear an actiwatch (Mini Mitter Co., Inc.) on their non-dominant hand for one week. Actigraphy units are light-weight watch-like devices that measure sleep-related movement and activity in the client's home environment. Actigraphy data will be used to calculate sleep parameters such as the length and number of night-time awakenings; total sleep time; sleep efficiency and naps.
Timepoint [1] 253322 0
There are three timepoints: At baseline (T1); after CBT or waitlist (T2) and 3 months after completing CBT (T3).
Primary outcome [2] 253344 0
Sleep as measured by a week long sleep diary. Each day adolescents will complete a sleep/wake diary in which they will record periods of being asleep and being awake over a 24-hour period. Diaries will be completed for 1 week overlapping with actigraphy data. Diaries will be used to calculate sleep parameters such as sleep onset latency; the length and number of night-time awakenings; total sleep time; sleep efficiency and naps.
Timepoint [2] 253344 0
There are three timepoints: At baseline (T1); after CBT or waitlist (T2) and 3 months after completing CBT (T3).
Secondary outcome [1] 262423 0
Daytime sleepiness and fatigue: The Pediatric Daytime Sleepiness Scale (Drake et al., 2003) will provide a measure of daytime dysfunction. It consists of 8 items that ask children to rate how sleepy they feel in various situations (e.g., at school, on the bus, etc.) over the past two weeks. The Fatigue Severity Scale (Krupp, LaRocca, Muir-Nash & Steinberg, 1989) contains nine items assessing the severity of fatigue symptoms over the past week.
Timepoint [1] 262423 0
There are three timepoints: At baseline (T1); after CBT or waitlist (T2) and 3 months after completing CBT (T3).

Eligibility
Key inclusion criteria
Participants will be high-school age adolescents (12 to 17 years) diagnosed with a sleep disorder (and who do not meet exclusion criteria)
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The study will exclude individuals with:
i. a primary diagnosis of Delayed Sleep Phase Syndrome (DSPS), Restless leg syndrome, obstructive sleep apnoea, cataplexy and narcolepsy plus frequent parasomnias occurring more than 3 times per week.
ii. comorbid psychiatric conditions, where severity is judged to interfere with the ability to benefit from group-based therapy (e.g., unmanaged psychotic or suicidal behaviour).
iii. pervasive developmental disorders and those in abusive environments.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a random number generator will be used to generate the sequence of allocation
Masking / blinding
Open (masking not 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
Not yet recruiting
Date of first participant enrolment
Anticipated
10/01/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 244075 0
Charities/Societies/Foundations
Name [1] 244075 0
Rotary
Country [1] 244075 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
431 Glebe Point Rd
Glebe, NSW, 2037
Country
Australia
Secondary sponsor category [1] 251430 0
None
Name [1] 251430 0
Address [1] 251430 0
Country [1] 251430 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258172 0
Ethics committee address [1] 258172 0
Ethics committee country [1] 258172 0
Date submitted for ethics approval [1] 258172 0
25/11/2009
Approval date [1] 258172 0
Ethics approval number [1] 258172 0

Summary
Brief summary
Sleep problems are common during adolescence and have a significant impact on the daily functioning and future potential of young people. This project evaluates the effectiveness of Cognitive-Behavioural Treatment (CBT) for sleep disorders in high-school aged young persons. Young people will take part in a randomised controlled trial in which they will be randomly allocated to complete a 7-week group-based Cognitive-Behavioural program for sleep or a 7-week waitlist control condition. Participants allocated to the waitlist condition will be asked to wait 7 weeks and be assessed again prior to beginning treatment. The effect of treatment will be measured on young persons’ sleep, mood, daily functioning, externalising behaviour and quality of life immediately after completing treatment and 3 months later.

Hypotheses: We expect that compared with the no-treatment waitlist group, young people that complete CBT will show:
1) Improved sleep/wake behaviour, including less time to fall asleep, longer total sleep duration, fewer night-time awakenings, and more consolidated sleep.
2) Improved daytime functioning including less reported daytime sleepiness and fatigue.
3) Improved anxiety and depression symptomatology.
4) Improved quality of life.
5) Reduced externalising difficulties on questionnaire measures of disruptive, aggressive and delinquent behaviours. It is expected that treatment gains will be maintained at 3 month follow up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30543 0
Address 30543 0
Country 30543 0
Phone 30543 0
Fax 30543 0
Email 30543 0
Contact person for public queries
Name 13790 0
Administration - The Woolcock Clinic
Address 13790 0
431 Glebe Point Rd, Glebe, NSW, 2037
Country 13790 0
Australia
Phone 13790 0
+61 2 9114 0000
Fax 13790 0
+61 2 9114 0010
Email 13790 0
[email protected]
Contact person for scientific queries
Name 4718 0
Dr Amanda Gamble
Address 4718 0
431 Glebe Point Rd, Glebe, NSW, 2037
Country 4718 0
Australia
Phone 4718 0
+61 2 9114 0000
Fax 4718 0
+61 2 9114 0010
Email 4718 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.