Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000143426
Ethics application status
Approved
Date submitted
30/12/2006
Date registered
23/02/2007
Date last updated
23/02/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of brief Cognitive Behavioural Therapy for primary insomnia in a primary care setting to improve the quality of sleep. A Randomised controlled trial
Scientific title
Efficacy of brief Cognitive Behavioural Therapy for primary insomnia in a primary care setting to improve the quality of sleep. A Randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary insomnia 1637 0
Condition category
Condition code
Mental Health 1745 1745 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
sleep deprivation of 5.5 hrs per night for the intervention. The duration of the intervention is 6 weeks. The participants visit the study at baseline and 2 weeks and followed by telephone at the end of 6 weeks. Sleep deprivation is considered to be a cognitive behavioural technique although in this study it is without a cognitive restructuring aspect. If participants sleep improves they are encouraged to sleep for increasingly longer periods.
Intervention code [1] 1530 0
Behaviour
Comparator / control treatment
General sleep hygiene for the control group such as going to be at the same time each night avoiding cafffeine.
Control group
Active

Outcomes
Primary outcome [1] 2432 0
Sleep quality.
Timepoint [1] 2432 0
Measured at 6 weeks by a telephone interviewer blind to the intervention. Comparisons will be made between the intervention and control group at 6 weeks.
Secondary outcome [1] 4200 0
Sleep duration.
Timepoint [1] 4200 0
This is measured at 6 weeks by a telephone interviewer blind to the intervention. Comparisons will be made between the intervention and control group at 6 weeks. It will be based over the last week of the trial (i.e sleep duration).

Eligibility
Key inclusion criteria
Not depressed/anxious on hospital anxiety and depression scale.
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No sleeping medication for 2 weeks before starting the study, cannot speak english fluently and dementia.

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



Intervention assignment
Parallel
Other design features
The participant is blind to the other intervention and the outcome assessor is blind to the intervention group
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
58
Accrual to date
Final
Recruitment outside Australia
Country [1] 459 0
New Zealand
State/province [1] 459 0

Funding & Sponsors
Funding source category [1] 1894 0
University
Name [1] 1894 0
University of Auckland
Country [1] 1894 0
New Zealand
Primary sponsor type
Individual
Name
Dr Anthony Fernando
Address
Country
Secondary sponsor category [1] 1713 0
Individual
Name [1] 1713 0
Prof Bruce Arroll
Address [1] 1713 0
Country [1] 1713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3520 0
northern ethics committee new zealand
Ethics committee address [1] 3520 0
Ethics committee country [1] 3520 0
New Zealand
Date submitted for ethics approval [1] 3520 0
Approval date [1] 3520 0
19/12/2005
Ethics approval number [1] 3520 0
NTX /05/09/117

Summary
Brief summary
RCT of sleep deprivation versus sleep hygiene for primary insomnia in adults. Primary insomnia is a condition is a diagnosis of exclusion where there is poor sleep but no other reason for it. The theory behind this is that the "sleep clock" is malfunctioning and the intervention of sleep deprivation enables a resetting of the clock.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27464 0
Address 27464 0
Country 27464 0
Phone 27464 0
Fax 27464 0
Email 27464 0
Contact person for public queries
Name 10719 0
Bruce Arroll
Address 10719 0
Dept of General Practice and Primary Health Care University of Auckland Private Bag 92019 Auckland
Country 10719 0
New Zealand
Phone 10719 0
6493737599 ext 86978
Fax 10719 0
6493737624
Email 10719 0
[email protected]
Contact person for scientific queries
Name 1647 0
Bruce Arroll
Address 1647 0
Dept of General Practice and Primary Health Care University of Auckland Private Bag 92019 Auckland
Country 1647 0
New Zealand
Phone 1647 0
6493737599 ext 86978
Fax 1647 0
6493737624
Email 1647 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.