Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000222549
Ethics application status
Approved
Date submitted
11/04/2006
Date registered
2/06/2006
Date last updated
2/06/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation into the relationship between Sleep, Pain and Depression
Scientific title
An investigation into the effect of Cognitive Behavioural Group Therapy and Sleep Hygiene Material on sleep quality and quantity, depression, anxiety and coping skills for individuals experiencing Insomnia Secondary to a medical condition (chronic pain).
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals experiencing insomnia secondary to a medical condition (chronic pain) 1200 0
Condition category
Condition code
Other 1285 1285 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1. Four, fortnightly, 2hr group sessions of Cognitive Behavioural Therapy designed to treat insomnia secodary to chronic pain
2. Provision of sleep hygiene material, in booklet form, developed to help manage insomnia secondary to chronic pain and follow up phone calls over 8 weeks
Intervention code [1] 973 0
Behaviour
Comparator / control treatment
3. Wait list control group with fortnightly phone calls over 8 weeks to control for clinician contact.
Control group
Active

Outcomes
Primary outcome [1] 1742 0
Positive changes in factors related to pain including ability to cope with or manage pain
Timepoint [1] 1742 0
At 1, 3, and 6 months following the intervention
Secondary outcome [1] 3097 0
Improvements in mood, specifically anxiety and depression following improvements in sleep.
Timepoint [1] 3097 0
At 1, 3 and 6 months.
Secondary outcome [2] 3098 0
Greater improvements in cognitive behavioural therapy group participants compared to sleep hygiene participants.
Timepoint [2] 3098 0
At 1, 3 and 6 months.

Eligibility
Key inclusion criteria
Diagnosis of insomnia secondary to chronic pain.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosis of breathing related sleep disorder or narcolepsy, the inability or unwillingness to attend and participate in group sessions and a non-English speaking background.

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)
Participant treatment allocation will be placed in sealed opaque sequentially numbered envelopes. After the participant has consented the researcher will view a random numbers table and select the corresponding envelope to determine if the participant will be allocated to CBT, sleep hygiene or wait list control condition
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Visual basic software will be used to generate the table of random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1411 0
University
Name [1] 1411 0
University of Newcastle
Country [1] 1411 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Country
Australia
Secondary sponsor category [1] 1237 0
Other
Name [1] 1237 0
Woolcock Institute of Medical Research
Address [1] 1237 0
Country [1] 1237 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2768 0
Faculty of Science and Information Technology at the University of Newcastle
Ethics committee address [1] 2768 0
Ethics committee country [1] 2768 0
Australia
Date submitted for ethics approval [1] 2768 0
Approval date [1] 2768 0
Ethics approval number [1] 2768 0
SCIT05/48

Summary
Brief summary
This research is being conducted in an effort to understand how improvements in sleep may affect factors related to pain and mood.
There are three components to this research project, a group Cognitive Behavioural Therapy program, a Sleep Hygiene program, where participants are provided with reading material on how they can improve their sleep, and a wait list. The wait list is an important part of the study because it will provide information about how sleep patterns change over time. This study has two main hypotheses. The first is that the Cognitive Behavioural Therapy program will lead to greater improvements in sleep quality and quantity than the sleep hygiene program and the second is that improved sleep quantity and/or quality will increase individuals’ ability to cope with or manage pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36246 0
Address 36246 0
Country 36246 0
Phone 36246 0
Fax 36246 0
Email 36246 0
Contact person for public queries
Name 10162 0
Lauren Brown
Address 10162 0
School of Behavioural Sciences
University of Newcastle
Callaghan NSW 2308
Country 10162 0
Australia
Phone 10162 0
+61 2 49217768
Fax 10162 0
Email 10162 0
[email protected]
Contact person for scientific queries
Name 1090 0
Mark Chorlton
Address 1090 0
School of Behavioural Sciences
University of Newcastle
Callaghan NSW 2308
Country 1090 0
Australia
Phone 1090 0
+61 249217260
Fax 1090 0
Email 1090 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.