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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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

Study type
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
Comparator / control treatment
3. Wait list control group with fortnightly phone calls over 8 weeks to control for clinician contact.
Control group

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.

Key inclusion criteria
Diagnosis of insomnia secondary to chronic pain.
Minimum age
18 Years
Maximum age
Not stated
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 2768 0
Approval date [1] 2768 0
Ethics approval number [1] 2768 0

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

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
Phone 10162 0
+61 2 49217768
Fax 10162 0
Email 10162 0
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
Phone 1090 0
+61 249217260
Fax 1090 0
Email 1090 0

No information has been provided regarding IPD availability
Summary results
No Results