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Trial registered on ANZCTR


Registration number
ACTRN12610000974000
Ethics application status
Not yet submitted
Date submitted
20/09/2010
Date registered
12/11/2010
Date last updated
7/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcomes of cognitive-behavioural therapy for insomnia in relation to therapy format
Scientific title
The effect of cognitive-behavioural therapy for insomnia (CBTi) on subjective sleep quality and quantity in relation to therapy format
Secondary ID [1] 252721 0
N/A
Universal Trial Number (UTN)
U1111-1117-1636
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 258215 0
Condition category
Condition code
Mental Health 258392 258392 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Behavioural Therapy (CBT) is mainly based on psychoeducation and structured behaviour modification for the long term treatment of insomnia. The methods used in our program include environment and lifestyle modifications, teaching of relaxation techniques and structured sleep schedule modifications aiming to improve sleep initiation and continuity.

Our program has two formats:

- 2 group sessions with a trained therapist followed by 2 individual sessions

or

- 4 group sessions with a trained therapist

In either cases, sessions last for one and half hours every fortnight.
Intervention code [1] 257231 0
Behaviour
Intervention code [2] 257232 0
Other interventions
Intervention code [3] 257233 0
Lifestyle
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259237 0
Self-reported sleep quality and quantity on questionnaires
- Pittsburgh Sleep Quality Index (PSQI)
- Glasgow Sleep Effort Scale
- Insomnia Severity Index
Timepoint [1] 259237 0
1. At the begining of the first treatment session
2. At the end of the four session programme
3. Six months from completion of the programme
4. Twelve months from completion of the programme
5. Three years from completion of the programme
Secondary outcome [1] 265643 0
Self-reported dirunal fatigue on questionnaires
- Epworth Sleepiness Scale (ESS)
- Fatigue Severity Scale (FSS)
Timepoint [1] 265643 0
1. At the begining of the first treatment session
2. At the end of the four session programme
3. Six months from completion of the programme
4. Twelve months from completion of the programme
5. Three years from completion of the programme
Secondary outcome [2] 265644 0
Self-reported cognitions about sleep and mood on questionnaires
- Depression Anxiety and Stress Scale (DASS)
- Beliefs and Attitudes Scale
Timepoint [2] 265644 0
1. At the begining of the first treatment session
2. At the end of the four session programme
3. Six months from completion of the programme
4. Twelve months from completion of the programme
5. Three years from completion of the programme

Eligibility
Key inclusion criteria
any individual with insomnia symptoms for longer than 1 month (criteria from the Diagnostic and Statistical Manual of Mental Disorders (DSM IV))
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. any individual who does not have a good command of oral and written English
2. any individual who has a diagnosed psychotic disorder
3. any individual who has severe depression/anxiety, any psychotic disorder and/or would be unlikely to benefit from a group educational program

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)
New participants will be recruited by sleep psychologists and doctors at the Woolcock Institute of Medical Research. Potential participants will choose to contribute to the study on a voluntary basis after being explained what the study involves and that their decision to participate will not affect their therapeutical relationship nor the treatment received at the at the Woolcock Institute of Medical Research.


All participants will be allocated to the CBTi programme.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
27/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257677 0
Self funded/Unfunded
Name [1] 257677 0
Country [1] 257677 0
Primary sponsor type
Individual
Name
Prof Delwyn Bartlett
Address
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
NSW 2050
Country
Australia
Secondary sponsor category [1] 256893 0
None
Name [1] 256893 0
Address [1] 256893 0
Country [1] 256893 0
Other collaborator category [1] 251518 0
Individual
Name [1] 251518 0
Rebecca Robillard
Address [1] 251518 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
NSW 2050
Country [1] 251518 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259704 0
Sydney South West Area Health Service (SSWAHS) Royal Prince Alfred Hospital Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 259704 0
C/- Research Development Office
Level 3, Building 92
Royal Prince Alfred Hospital
Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 259704 0
Australia
Date submitted for ethics approval [1] 259704 0
31/08/2010
Approval date [1] 259704 0
Ethics approval number [1] 259704 0

Summary
Brief summary
This project aims to compare the outcomes of two different formats of Cognitive Behavioural Therapy for insomnia (CBT-i) programmes implemented by our team in real life clinic populations.

Key components of these education-based programmes include:
- teaching about sleep mechanisms and factors contributing to the development and maintenance of insomnia
- challenging current beliefs about sleep
- structured behavior modification
- strategies to cope with anxiety and mood disturbances

CBT-i can be used in different formats, with individual sessions, group sessions or both. This study will compare two formats of CBT-i presented in a standardised slide presentation:
- The CBT-i4 Programme which involves 4 group sessions
- The CBT-i2-2 Programme which involves 2 group sessions with 2 subsequent individual follow-up sessions focussing on the participant’s implementation of the behavioural strategies learnt during the group session and allowing individual guidance and support.

These two programmes will be conducted at the Woolcock Institute of Medical Research with individuals who have at least a one month history of insomnia symptoms (DSM-IV criteria). Voluntary participants will be recruited by sleep psychologists and sleep physicians at the Woolcock Insomnia Clinic after completing an assessment for sleep disorders. To quantify improvements in subjective sleep quality assessments, participants will be asked to complete questionnaires and sleep diaries between the assessment visit and the first CBT-i session, at the end of the programme (4th group session or 2nd individual session) and 6 months after the last session.

The current study will also include data from a CBT-i4 Programme previously run at Royal Prince Alfred Hospital’s Sleep Unit through a project that has been approved by the SSWAHS Ethics Review Committee (RPAH ZONE).

Results from the current study are likely to provide empiric evidence on ways to optimize cognitive-behaviour therapy for insomnia in real world clinical settings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31662 0
Address 31662 0
Country 31662 0
Phone 31662 0
Fax 31662 0
Email 31662 0
Contact person for public queries
Name 14909 0
Delwyn Bartlett
Address 14909 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
NSW 2050
Country 14909 0
Australia
Phone 14909 0
+61 2 9114 0460
Fax 14909 0
+61 2 9114 0465
Email 14909 0
delwyb@med.usyd.edu.au
Contact person for scientific queries
Name 5837 0
Delwyn Bartlett
Address 5837 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
NSW 2050
Country 5837 0
Australia
Phone 5837 0
+61 2 9114 0460
Fax 5837 0
+61 2 9114 0465
Email 5837 0
delwyb@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

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No documents have been uploaded by study researchers.

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