Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000883910
Ethics application status
Approved
Date submitted
13/07/2020
Date registered
7/09/2020
Date last updated
7/09/2020
Date data sharing statement initially provided
7/09/2020
Date results information initially provided
7/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of a Brief Treatment Program of Cognitive Behavior Therapy for Insomnia in Older Adults
Scientific title
Evaluation of a Brief Treatment Program of Cognitive Behavior Therapy on sleep quality and timing in Older Adults suffering from Insomnia.
Secondary ID [1] 301761 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
insomnia 318220 0
Condition category
Condition code
Mental Health 316232 316232 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 4-week, group-based treatment program of Cognitive Behaviour Therapy for Insomnia including bedtime restriction therapy, sleep education, and cognitive restructuring.

The intervention comprised 1 x 1 hour consultations per week for 4 weeks with 6-8 people per group and delivered by a psychologist. Activities completed during the intervention sessions were educational sessions and open discussion of topics covered in the educational sessions. Participants were asked to keep a sleep diary and complete questionnaires about their insomnia severity, daytime functioning, and their beliefs about and confidence in their sleep.

The intervention was designed specifically for this study.
Intervention code [1] 318056 0
Treatment: Other
Intervention code [2] 318301 0
Behaviour
Comparator / control treatment
Wait list control group.
The intervention was offered to the control group following the 3-month follow up.
Control group
Active

Outcomes
Primary outcome [1] 324422 0
Subjective sleep quality as assessed by sleep diary reported sleep efficiency
Timepoint [1] 324422 0
Pre-treatment, Immediately post treatment (primary endpoint), 3-months post treatment
Primary outcome [2] 324423 0
Insomnia Severity Index
Timepoint [2] 324423 0
Pre-treatment, Immediately post treatment (primary endpoint), 3-months post treatment
Secondary outcome [1] 384592 0
Subjective sleep quality as assessed by sleep diary reported wake after sleep onset
Timepoint [1] 384592 0
Immediately post-treatment
Secondary outcome [2] 384593 0
Fatigue as assessed by the Flinders Fatigue Scale
Timepoint [2] 384593 0
Immediately post-treatment
Secondary outcome [3] 385528 0
Beliefs and attitudes about sleep, assessed using the Dysfunctional Beliefs and Attitudes Scale
Timepoint [3] 385528 0
Immediately post-treatment
Secondary outcome [4] 385529 0
Daytime sleepiness, assessed by the Epworth Sleepiness Scale
Timepoint [4] 385529 0
Immediately post-treatment
Secondary outcome [5] 385531 0
Daytime functioning, assessed by the Daytime Feelings and Functioning Scale
Timepoint [5] 385531 0
Immediately post-treatment
Secondary outcome [6] 385532 0
Anxiety about sleep, assessed using the Sleep Anticipatory Anxiety Scale
Timepoint [6] 385532 0
Immediately post-treatment
Secondary outcome [7] 385534 0
Confidence in ability to sleep, assessed using the Sleep Self-Efficacy Scale
Timepoint [7] 385534 0
Immediately post-treatment

Eligibility
Key inclusion criteria
(1) wake after sleep onset of greater than 30 min, at least three nights per w for a reported duration of at least 6 mo, and (2) had impaired daytime functioning such as daytime fatigue or memory problems. All participants were required to remain free of sedatives/hypnotic medication for at least 1 mo prior to and throughout their involvement in the study
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with clear clinical symptoms of other sleep disorders or severe medical/psychiatric disorders were excluded. Participants were excluded if they (1) indicated the presence of sleep apnea (AHI >15) or restless legs syndrome, (2) indicated the presence of major depression, anxiety, or serious cognitive impairment, or (3) consumed excessive amounts of caffeine (> 300 mg/day) or alcohol (> two standard drinks/day).

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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/06/2008
Date of last participant enrolment
Anticipated
Actual
10/08/2009
Date of last data collection
Anticipated
Actual
14/02/2011
Sample size
Target
118
Accrual to date
Final
118
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 306191 0
Government body
Name [1] 306191 0
National Health and Medical Research Council
Country [1] 306191 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd, Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 306664 0
None
Name [1] 306664 0
Address [1] 306664 0
Country [1] 306664 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306403 0
Flinders University Social and Behavioral Ethics Committee
Ethics committee address [1] 306403 0
Sturt Rd, Bedford Park SA 5042
Ethics committee country [1] 306403 0
Australia
Date submitted for ethics approval [1] 306403 0
Approval date [1] 306403 0
21/02/2008
Ethics approval number [1] 306403 0

Summary
Brief summary
The current study used a randomized controlled trial to investigate the effects of a brief, group-based CBT-I program in a large sample of older adults with chronic primary insomnia not currently taking hypnotic/sleep aid medications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103762 0
Prof Leon Lack
Address 103762 0
Flinders Health and Medical Research Institute (FHMRI) Sleep Health
College of Medicine & Public Health
Flinders University

FHMRI Sleep Health, Level 2A
Box 6, Mark Oliphant Building
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 103762 0
Australia
Phone 103762 0
+61 8 82012391
Fax 103762 0
Email 103762 0
[email protected]
Contact person for public queries
Name 103763 0
Dr Nicole Lovato
Address 103763 0
Flinders Health and Medical Research Institute (FHMRI) Sleep Health
College of Medicine & Public Health
Flinders University

FHMRI Sleep Health, Level 2A
Box 6, Mark Oliphant Building
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 103763 0
Australia
Phone 103763 0
+61 8 72218307
Fax 103763 0
Email 103763 0
[email protected]
Contact person for scientific queries
Name 103764 0
Dr Nicole Lovato
Address 103764 0
Flinders Health and Medical Research Institute (FHMRI) Sleep Health
College of Medicine & Public Health
Flinders University

FHMRI Sleep Health, Level 2A
Box 6, Mark Oliphant Building
5 Laffer Drive, Bedford Park, South Australia, 5042
Country 103764 0
Australia
Phone 103764 0
+61 8 72218307
Fax 103764 0
Email 103764 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are ethical and logistical considerations that would prevent IPD sharing.


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
EmbaseSleep misestimation among older adults suffering from insomnia with short and normal objective sleep duration and the effects of cognitive behavior therapy.2021https://dx.doi.org/10.1093/sleep/zsaa250
N.B. These documents automatically identified may not have been verified by the study sponsor.