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Trial registered on ANZCTR


Registration number
ACTRN12618000359235
Ethics application status
Approved
Date submitted
16/02/2018
Date registered
9/03/2018
Date last updated
9/03/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
how best to treat insomnia:comparing cognitive therapy with mindfulness
Scientific title
Enhancing CBT for Chronic Insomnia: A
Randomised Clinical Trial of Additive Components
of Mindfulness or Cognitive Therapy on length and quality of sleep.
Secondary ID [1] 294079 0
none
Universal Trial Number (UTN)
U1111-1209-4795
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia 306642 0
Condition category
Condition code
Mental Health 305743 305743 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mindfulness Therapy (MT): 4 x 1 hour per week for 4 weeks delivered in an urban medical practise by registered psychologists. In session meditations included practising observing without judging experiences, focusing on the breath, focusing on the senses in the here and now. Participants were also encouragedto listen to Mindfulness Meditation CDs 6 days out of 7 (including Body Scan meditation and Sitting meditation).
Cognitive Therapy (CBT): 4 x 1 hour per week for 4 weeks delivered in an urban medical practise by registered psychologists. The intervention includes explaining to patients how cognition mediate poor sleep and tailored behavioural experiments to demonstrate how changing these ideas improves sleep .

Each participant received either MT or CBT in a one-to-one format. there were no formal assessment of checking homework assignments for either CBT or MT
Intervention code [1] 300349 0
Treatment: Other
Comparator / control treatment
wait-list control: offered therapy after a 4 week period which was the equivalent time to the active treatments. After this time participants were allocated to MT or CBT on a random basis
Control group
Active

Outcomes
Primary outcome [1] 304815 0
Insomnia Severity Index
Timepoint [1] 304815 0
one week after treatment completed
Secondary outcome [1] 343277 0
Pittsburgh Sleep Quality Index
Timepoint [1] 343277 0
one week after treatment finished and and 3 months post-intervention completion completion
Secondary outcome [2] 343278 0
sleep log total sleep time,
Timepoint [2] 343278 0
one week after treatment finished and and 3 months post-intervention completion
Secondary outcome [3] 344121 0
sleep log sleep onset latency
Timepoint [3] 344121 0
one week after treatment finished and and 3 months post-intervention completion
Secondary outcome [4] 344122 0
sleep log number of nocturnal awakenings
Timepoint [4] 344122 0
one week after treatment finished and and 3 months post-intervention completion
Secondary outcome [5] 344123 0
sleep log wake time after sleep onset for each night of sleep
Timepoint [5] 344123 0
one week after treatment finished and and 3 months post-intervention completion
Secondary outcome [6] 344124 0
A Philips Actiwatch was worn on the non dominant wrist for 7 days (continuous wearing other than showering/swimming).. Outcomes measure: Total Sleep Time
Timepoint [6] 344124 0
one week after treatment finished and and 3 months post-intervention completion
Secondary outcome [7] 344125 0
A Philips Actiwatch was worn on the non dominant wrist for 7 days (continuous wearing other than showering/swimming). Outcomes measure: Sleep Onset Latency
Timepoint [7] 344125 0
one week after treatment finished and and 3 months post-intervention completion
Secondary outcome [8] 344126 0
A Philips Actiwatch was worn on the non dominant wrist for 7 days (continuous wearing other than showering/swimming). Measure Number Awakenings
Timepoint [8] 344126 0
one week after treatment finished and and 3 months post-intervention completion
Secondary outcome [9] 344127 0
A Philips Actiwatch was worn on the non dominant wrist for 7 days (continuous wearing other than showering/swimming), measuring Wake After Sleep Onset
Timepoint [9] 344127 0
one week after treatment finished and and 3 months post-intervention completion

Eligibility
Key inclusion criteria
(i) 18–65 years of age; (ii) complaint of difficulty initiating or maintaining
sleep for at least 6 months; (iii) mean sleep onset latency
or minutes awake after sleep for longer than 30 min for
at least three nights per week as assessed by 1-week sleep diary;
(iv) interference in daytime functioning; (v) total sleep
time on sleep diary under 6.5 h for more than three nights
out of every seven; and (vi) taking no medication to assist
sleep or be taking a stable dose of medication (stable for
1 month).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) they presented clear evidence
of other sleep disorders (sleep apnoea, periodic leg
movements during sleep, nightmare disorder, narcolepsy,
parasomnia) based on a sleep history assessment interview
protocol (ii) they were receiving treatment of insomnia from another
mental health professional; (iii) they presented with
sleep disturbances due to a medical/physical condition as
assessed by clinical interview; (iv) they had sleep disturbances
due to the physiological effect of a substance; and
(v) the insomnia was assessed as purely secondary to another
psychological disorder.

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)
Allocation involved contacting the holder of the allocation schedule who was not at the site where the treatment was provided.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer-generated
random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 298709 0
University
Name [1] 298709 0
Murdoch University
Address [1] 298709 0
90 South St Murdoch, WA 6153
Country [1] 298709 0
Australia
Primary sponsor type
University
Name
Murdoch University
Address
90 South St Murdoch, WA 6153
Country
Australia
Secondary sponsor category [1] 297880 0
None
Name [1] 297880 0
Address [1] 297880 0
Country [1] 297880 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299656 0
Murdoch University
Ethics committee address [1] 299656 0
90 South St Murdoch, WA 6153
Ethics committee country [1] 299656 0
Australia
Date submitted for ethics approval [1] 299656 0
25/03/2009
Approval date [1] 299656 0
10/08/2009
Ethics approval number [1] 299656 0
2009/101

Summary
Brief summary
the study sought to determine whether Cognitive Therapy or Mindfulness-based therapy better assists participants with primary insomnia. Participants were allocated to each treatment or a wait-list control. Those in the wait-list were allocated to an active treatment after the wait-list period. Outcome measures included quality of sleep and amount of time asleep.

Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 81194 0
A/Prof Christopher Lee
Address 81194 0
Department of Psychology and Exercise Science
Murdoch University
90 South St
Murdoch WA 6153
Country 81194 0
Australia
Phone 81194 0
+61403050431
Fax 81194 0
Email 81194 0
chris.lee@uwa.edu.au
Contact person for public queries
Name 81195 0
A/Prof Christopher Lee
Address 81195 0
Department of Psychology and Exercise Science
Murdoch University
90 South St
Murdoch WA 6153
Country 81195 0
Australia
Phone 81195 0
+61403050431
Fax 81195 0
Email 81195 0
chris.lee@uwa.edu.au
Contact person for scientific queries
Name 81196 0
A/Prof Christopher Lee
Address 81196 0
Department of Psychology and Exercise Science
Murdoch University
90 South St
Murdoch WA 6153
Country 81196 0
Australia
Phone 81196 0
+61403050431
Fax 81196 0
Email 81196 0
chris.lee@uwa.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary