Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000123044
Ethics application status
Approved
Date submitted
4/02/2010
Date registered
5/02/2010
Date last updated
10/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Common thoughts occuring in insomnia and a comparison of psychological treatments
Scientific title
A cognitive-behavioural therapy comparison for adults (18-60yrs) with insomnia, to improve poor sleep and wellbeing
Secondary ID [1] 1378 0
Nil known
Universal Trial Number (UTN)
U1111-1113-5711
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 256748 0
Condition category
Condition code
Mental Health 256903 256903 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive-behavioural therapy for insomnia(CBT-I; with problem-solving training component) Therapy involves six weekly treatment sessions (1-2hrs/week) comprised of one initial group session (groups of 4-5 people) then approximately 5 individual sessions. Therapy will be administered by a clinical research student/intern psychologist under the supervision of a fully qualified clinical psychology staff member (Dr Richard O'Kearney) as part of the Doctor of Psychology clinical program at the Australian National University to form a research thesis. Group sessions will involve sleep education, relaxation training and stimulus control (behavioural intervention) - all participants in the treatment study (50 in total) take part in the same group treatment, after which they are randomly allocated to one of two individual interventions (25 to each). Individual sessions will involve problem-solving training (a discussion-based therapy with homework sheets and sleep diary focused on improving problem-solving skills). Additionally, there is an Insomnia Thought Study involving the comparison of 10 normal sleepers to 50 people with insomnia. The study will involve the completion of survey forms and a thought diary during one week (prior to treatment for the insomnia participants and forming part of their sleep diary assessment) which will take 1-2hrs in total. Participants in the thought study may be reimbursed $10-15 for their participation.
Intervention code [1] 255965 0
Treatment: Other
Comparator / control treatment
Standard treatment (Cognitive-behavioural therapy for insomnia with cognitive therapy component) Therapy involves six weekly treatment sessions (1-2hrs/week) comprised of one initial group session (groups of 4-5 people) then approximately 5 individual sessions. Therapy will be administered by a clinical research student/intern psychologist under the supervision of a fully qualified clinical psychology staff member (Dr Richard O'Kearney) as part of the Doctor of Psychology clinical program at the Australian National University to form a research thesis. Group sessions will involve sleep education, relaxation training and stimulus control (behavioural intervention) - all participants in the treatment study (50 in total) take part in the same group treatment, after which they are randomly allocated to one of two individual interventions (25 to each). Individual sessions will involve cognitive therapy (a discussion-based therapy with homework sheets and sleep diary focused on reducing dysfunctional beliefs about sleep).
Control group
Active

Outcomes
Primary outcome [1] 257769 0
Mean score on Insomnia Severity Index
Timepoint [1] 257769 0
At baseline, post-group treatment (approxiamtely 2 weeks), post-CBT (approximately 6 weeks) and at one month follow-up.
Primary outcome [2] 257770 0
Mean variables in sleep diary (e.g. time taken to sleep, wake after sleep onset, sleep duration and satisfaction)
Timepoint [2] 257770 0
At baseline, post-group treatment (approxiamtely 2 weeks), post-CBT (approximately 6 weeks) and at one month follow-up.
Primary outcome [3] 257771 0
Mean Scores on Pittsburgh Sleep Quality Index
Timepoint [3] 257771 0
At baseline, post-group treatment (approxiamtely 2 weeks), post-CBT (approximately 6 weeks) and at one month follow-up.
Secondary outcome [1] 263171 0
Mean scores on Social Problem-Solving Inventory
Timepoint [1] 263171 0
At baseline, post-group treatment (approxiamtely 2 weeks), post-CBT (approximately 6 weeks) and at one month follow-up.
Secondary outcome [2] 263172 0
Mean scores on Dysfunctional Beliefs about Sleep Scale
Timepoint [2] 263172 0
At baseline, post-group treatment (approxiamtely 2 weeks), post-CBT (approximately 6 weeks) and at one month follow-up.
Secondary outcome [3] 263173 0
Mean scores on Depression, Anxiety and Stress index
Timepoint [3] 263173 0
At baseline, post-group treatment (approxiamtely 2 weeks), post-CBT (approximately 6 weeks) and at one month follow-up.
Secondary outcome [4] 263174 0
Mean scores on Penn State Worry Questionnaire
Timepoint [4] 263174 0
At baseline, post-group treatment (approxiamtely 2 weeks), post-CBT (approximately 6 weeks) and at one month follow-up.

Eligibility
Key inclusion criteria
Native or primary English speaker

Insomnia Treatment Group (50 participants)
Subjective complaint of insomnia and meeting the Research Diagnostic Criteria (Amercian Academy of Sleep Medicine, 2004) as follows:
One or more sleep-related complaints (initiating, maintaining, early waking, poor quality)
Difficulty occurs despite adequate opportunity for sleep
At least one daytime impairment reported (e.g. fatigue, mood, attention, concentration, motivation, energy, worries about sleep)
In addition, the sleep difficulties occurring for a minimum of 3 -6 months

Participants will be accepted into the trial if they have comorbid depression or anxiety conditions that are assessed to be relatively stable, mild to moderate, and not requiring immediate treatment targeted at those symptoms.

Insomnia Thought Study (including Insomnia Treatment participants plus 50 normal sleepers)
Meet the Research Diagnostic Criteria for Normal Sleepers:
No complaints of sleep disturbance or daytime symptoms attributable to unsatisfactory sleep
Has a routine standard sleep/wake schedule
No evidence of a sleep-disruptive medical or mental disorder
No evidence of sleep disruption due to substance exposure, use, abuse, or withdrawal
No evidence of a primary sleep disorder
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Under 18yrs and over 60yrs. Not native or primary English speakers Participation in existing psychological treatment programs that may confound the results of the present study (e.g. CBT programs). Sleep disturbance not meeting the Inclusion Criteria Evidence of severe psychiatric illness or primary sleep disorder other than insomnia. Sleep disruption due to substance exposure, use, abuse, or withdrawal.

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



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2010
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
23/11/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256463 0
University
Name [1] 256463 0
Australian National University
Country [1] 256463 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
ANU
Psychology Department
Building 39
ACTON
ACT 0200
Country
Australia
Secondary sponsor category [1] 255772 0
None
Name [1] 255772 0
Address [1] 255772 0
Country [1] 255772 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258516 0
Australian National University Human Research Ethics Committee
Ethics committee address [1] 258516 0
Ethics committee country [1] 258516 0
Australia
Date submitted for ethics approval [1] 258516 0
10/02/2010
Approval date [1] 258516 0
03/03/2010
Ethics approval number [1] 258516 0
2010/018

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

Contacts
Principal investigator
Name 30802 0
Dr Melissa Pech
Address 30802 0
ANU Counselling Centre Building 18 North Rd ACTON ACT 0200
Country 30802 0
Australia
Phone 30802 0
+61 2 6125 2442
Fax 30802 0
Email 30802 0
[email protected]
Contact person for public queries
Name 14049 0
Richard O'Kearney
Address 14049 0
ANU Psychology Department
Building 39
ACTON
ACT 0200
Country 14049 0
Australia
Phone 14049 0
+ 61 2 6125 2795
Fax 14049 0
Email 14049 0
[email protected]
Contact person for scientific queries
Name 4977 0
Richard O'Kearney
Address 4977 0
ANU Psychology Department
Building 39
ACTON
ACT 0200
Country 4977 0
Australia
Phone 4977 0
+ 61 2 6125 2795
Fax 4977 0
Email 4977 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
SourceTitleYear of PublicationDOI
Dimensions AIA Randomized Controlled Trial of Problem-Solving Therapy Compared to Cognitive Therapy for the Treatment of Insomnia in Adults2013https://doi.org/10.5665/sleep.2640
N.B. These documents automatically identified may not have been verified by the study sponsor.