Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000668606
Ethics application status
Approved
Date submitted
21/09/2005
Date registered
20/10/2005
Date last updated
4/01/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of Cognitive Behavioural Therapy programme for insomnia
Scientific title
Evaluation and long term follow up of cognitive behavioural therapy (CBT) programme for individuals enrolled in the group insomnia program at Royal Prince Alfred Hospital
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 816 0
Condition category
Condition code
Other 880 880 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Insomnia is a distressing difficulty in falling asleep, staying asleep, waking early or a combination of these symptoms, where there is also a perception of insufficient sleep. Research has shown that CBT group treatment of insomnia is significantly effective in treatment outcomes (improved sleep and mood), reduced treatment time and resources. CBT group workshops have been running since October 2003 at RPAH. The current group workshop comprises of four, one and half hour sessions held once a fortnight. Our aim is to assess both the outcomes and effectiveness of this current insomnia program with long term follow up at 6 and 12 months and 3 years.
Intervention code [1] 662 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1137 0
Sleep Efficiency is the primary outcome. Sleep efficiency is derived from the formula of estimated total sleep time/time in bed and multiplied by 100/1. This formula is a component score of the Pittsburgh Sleep Quality Index (PSQI).
Timepoint [1] 1137 0
Sleep efficiency will be assessed at baseline and at the 4th session. Questionnaires will be sent to participants at 6 months, 12 months & 3 years.
Secondary outcome [1] 2092 0
Mood via the Depression
Timepoint [1] 2092 0
Measurements will be assessed at baseline, at the 4th session and again at 6 months, 12 months & 3 years.
Secondary outcome [2] 2093 0
Anxiety
Timepoint [2] 2093 0
Measurements will be assessed at baseline, at the 4th session and again at 6 months, 12 months & 3 years.
Secondary outcome [3] 2094 0
Stress Scale (DASS)
Timepoint [3] 2094 0
Measurements will be assessed at baseline, at the 4th session and again at 6 months, 12 months & 3 years.
Secondary outcome [4] 2095 0
Fatigue levels Fatigues Severity scale (FSS)
Timepoint [4] 2095 0
Measurements will be assessed at baseline, at the 4th session and again at 6 months, 12 months & 3 years.
Secondary outcome [5] 2096 0
Daytime sleepiness Epworth Sleepiness Scale (ESS)
Timepoint [5] 2096 0
Measurements will be assessed at baseline, at the 4th session and again at 6 months, 12 months & 3 years.
Secondary outcome [6] 2097 0
Deliefs and attitudes about sleep Dysfunctional Beliefs and Attitudes Scale (DBAS)
Timepoint [6] 2097 0
Measurements will be assessed at baseline, at the 4th session and again at 6 months, 12 months & 3 years.
Secondary outcome [7] 2098 0
Sleep effort Glasgow Sleep Effort Scale (GSES)
Timepoint [7] 2098 0
Measurements will be assessed at baseline, at the 4th session and again at 6 months, 12 months & 3 years.

Eligibility
Key inclusion criteria
Any individual with insomnia symptoms for greater than one month (DSM - IV) criteria.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
English as a second language which is not competent for understanding in a group setting or being able to read the powerpoint presentations or educational booklets.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/02/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 970 0
Other
Name [1] 970 0
Woolcock Institute of Medical Research
Country [1] 970 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 838 0
None
Name [1] 838 0
n/a
Address [1] 838 0
Country [1] 838 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2275 0
Royal Prince Alfred Hospital
Ethics committee address [1] 2275 0
Missenden Road NSW 2050
Ethics committee country [1] 2275 0
Australia
Date submitted for ethics approval [1] 2275 0
Approval date [1] 2275 0
Ethics approval number [1] 2275 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36157 0
Address 36157 0
Country 36157 0
Phone 36157 0
Fax 36157 0
Email 36157 0
Contact person for public queries
Name 9851 0
Ms Wendy Taylor
Address 9851 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9851 0
Australia
Phone 9851 0
+61 2 95156578
Fax 9851 0
+61 2 95505865
Email 9851 0
wtaylor@woolcock.org.au
Contact person for scientific queries
Name 779 0
Dr Delwyn Bartlett
Address 779 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 779 0
Australia
Phone 779 0
+61 2 93510917
Fax 779 0
+61 2 93510914
Email 779 0
delwynb@med.usyd.edu.au

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.