Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001509156
Ethics application status
Approved
Date submitted
26/09/2019
Date registered
31/10/2019
Date last updated
16/04/2021
Date data sharing statement initially provided
31/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of thought processes on sleep outcomes in adults aged 60 - 80 years
Scientific title
The role of dysfunctional beliefs around sleep in mediating the outcomes of online cognitive behavioural therapy for insomnia in community-dwelling older adults
Secondary ID [1] 299401 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 314577 0
Condition category
Condition code
Public Health 312915 312915 0 0
Other public health
Mental Health 313171 313171 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will examine sleep quality in adults aged 60 - 80 years residing in Western Australia. It will investigate whether cognitive or thought processes influence treatment outcomes of online CBTi in individuals with synchronous and asynchronous sleep pattern and sleep appraisal. Participants will be asked to complete an online questionnaire battery using Qualtrics software examining their sleep related beliefs and self-rated sleep quality, including Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) (Morin, Vallières, & Ivers, 2007), Pittsburgh Sleep Quality Index (PSQI)(Buysee, Reynolds, Monk, Berman, & Kupfer, 1989), Insomnia Severity Index (ISI) (Morin, 1993; Morin, Belleville, Bélanger, & Ivers, 2011), Depression, Anxiety and Stress Scale – 21 (DASS-21) (Lovibond & Lovibond, 1995), Glasgow Sleep Effort Scale (GSES) (Broomfield & Espie, 2005), Self-Efficacy for Sleep Scale (SE-S) (Lacks, 1987), Sleep Locus of Control Scale (SLOC) (Vincent, Sande, Read, & Giannuzzi, 2004), Pre-Sleep Arousal Scale (PSAS) (Nicassio, Mendlowitz, Fussell, & Petras, 1985, Morningness-Eveningness questionnaire (MEQ) (Horne & Ostberg, 1976), Treatment Acceptability Questionnaire (TAQ) (Hunsley, 1992) and the Sleep-Related Behaviours Questionnaire (SRBQ) (Ree & Harvey, 2004). In addition, participants will wear an actigraph (ActiGraph wGT3x-BT) and complete a sleep diary over 96 hours (72 hours plus an additional 24 hours to account for wear time non-adherence). The actigraphs will be posted by the PI and collected by courier at a time convenient for the participant. Participants will be considered poor sleepers if they have sleep-onset-latency or wake-after-sleep-onset of equal or more than 31 minutes at least once during the recording period, and will be considered complaining sleepers if they report having had a sleep problem (e.g. trouble falling asleep) for a minimum of six months. Based on their actigraphy results and sleep complaint status (complaining vs non-complaining sleepers), participants will be grouped into four sleep groups: non-complaining good sleepers (NG), complaining good sleepers (CG), non-complaining poor sleepers (NP), and complaining poor sleepers (CP). All groups will be asked to complete a four-session online CBTi sleep intervention, with NG providing the control group. Following the baseline assessment including recording of demographic information and sleep complaint, administration of the questionnaires, and actigraphy measurement, all groups (NG, CG, NP and CP) will receive the online CBTi instructions and a link to the online CBTi website. The programme consists of four lessons in a comic-based format. Participants will be asked to complete the four sessions (plus homework) of the online CBTi programme within four weeks (one session each week). Each session will take a minimum of twenty minutes to complete. Lesson one provides some background knowledge about sleep and insomnia and which factors are conducive to good sleep and which to insomnia. Lesson two & three address the management of thought and behaviours that interfere with sleep, and lesson four focusses on relaxation techniques. Since progress cannot be monitored directly, participants will receive weekly email reminders from the PI (via telephone) to confirm completion of each of the four online CBTi modules. Once the completion of the online CBTi programme has been confirmed with the participant, actigraphy, sleep diary and questionnaire measurements will be repeated post-treatment.
Intervention code [1] 315654 0
Behaviour
Comparator / control treatment
The non-complaining good sleeper (NG) group will provide the comparison group.
Control group
Active

Outcomes
Primary outcome [1] 321516 0
Objective sleep quality, measured via actigraphy (sleep efficiency rating)
Timepoint [1] 321516 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Primary outcome [2] 321704 0
Subjective sleep quality, measured via self-report questionnaire (global PSQI score)
Timepoint [2] 321704 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [1] 375207 0
Dysfunctional sleep beliefs, as assessed by DBAS-16
Timepoint [1] 375207 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [2] 376226 0
Sleep quality, as assessed by Pittsburgh Sleep Quality Index
Timepoint [2] 376226 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [3] 376227 0
Insomnia severity, as assessed by Insomnia Severity Index
Timepoint [3] 376227 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [4] 376228 0
Depression, as assessed by Depression, Anxiety and Stress Scale – 21
Timepoint [4] 376228 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [5] 376229 0
Sleep effort, as assessed by Glasgow Sleep Effort Scale
Timepoint [5] 376229 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [6] 376230 0
Sleep self-efficacy, as assessed by Self-Efficacy for Sleep Scale
Timepoint [6] 376230 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [7] 376231 0
Internal sleep locus of control, as assessed by Sleep Locus of Control Scale
Timepoint [7] 376231 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [8] 376232 0
Somatic arousal, as assessed by Pre-Sleep Arousal Scale
Timepoint [8] 376232 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [9] 376233 0
Circadian rhythm type (chronotype), as assessed by Morningness-Eveningness questionnaire
Timepoint [9] 376233 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [10] 376234 0
Acceptability of psychological treatments, as assessed by Treatment Acceptability Questionnaire
Timepoint [10] 376234 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [11] 376235 0
Safety behaviours relating to sleep, as assessed by Sleep-Related Behaviours Questionnaire
Timepoint [11] 376235 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [12] 376460 0
Anxiety, as assessed by Depression, Anxiety and Stress Scale – 21
Timepoint [12] 376460 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [13] 376461 0
Stress, as assessed by Depression, Anxiety and Stress Scale – 21
Timepoint [13] 376461 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)
Secondary outcome [14] 376463 0
Cognitive arousal, as assessed by Pre-Sleep Arousal Scale
Timepoint [14] 376463 0
Baseline (prior to completing online CBTi programme), and post-treatment (following completion of the eCBTi programme)

Eligibility
Key inclusion criteria
Participants are eligible to take part if they:
• Are aged 60-80 years, and ordinarily reside in Western Australia
• Have not been diagnosed with an existing sleep disorder other than insomnia
• Have not been diagnosed with a severe psychiatric or cognitive disorder, epilepsy or who have a high risk of falls
• Have not engaged in regular shift work in the past year
• Have reliable internet access and have some familiarity with using the internet and web-based resources
Minimum age
60 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Diagnosis of an existing sleep disorder other than insomnia, diagnosis of a severe psychiatric or cognitive disorder, epilepsy or a high risk of falls, regular shift work in the past year

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We aim to recruit a total of 60 participants into the study, however, recruitment will continue until a minimum of 10 participants (reflecting the minimum required sample size of n= 40) have been recruited into all groups, even if this means exceeding the recruitment target of 60 participants. A priori power analysis using the program G*Power was performed to assess whether the study will have enough power to detect significant differences in sleep outcomes between the study groups. A conservative effect size of 0.68 was taken into consideration based on the one calculated from a previous study (McCrae et al., 2005). Allowing for study differences and applying a smaller effect size of 0.40 to compensate, it was calculated that a sample size of 40 will have 80% power to detect this size effect with a = 0.05. In order to account for attrition rates and missing data, a total of 60 participants will be recruited into the study.

Due to the fact that sleep complaint status (sleep problem, e.g. initial insomnia, for a minimum of six months) is used to classify participants as complaining or non-complaining sleepers, two separate 2 (gender) x 2 (sleep group) multivariate analyses of variance (MANOVA) will be conducted to examine subjective sleep quantity by gender for complaining and non-complaining sleepers. Objective sleep quantity and dysfunctional beliefs about sleep by gender for the four sleep groups will be measured using four 2 (gender) x 4 (sleep group) MANOVAs.

Actigraphy measures will be scored using the Cole-Kripke algorithm, which is suitable for use with older populations (Cole, Kripke, Gruen, Mullaney, & Gillin, 1992), and ActiLife software (ActiLife 6 software, Version 6.13.1, ActiGraph). Autoscored data will be manually compared with the sleep diary in order to determine any incongruence between actigraph measurements and sleep diary.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2020
Actual
24/03/2020
Date of last participant enrolment
Anticipated
30/07/2020
Actual
29/01/2021
Date of last data collection
Anticipated
30/09/2020
Actual
24/03/2021
Sample size
Target
60
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 28118 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 303906 0
University
Name [1] 303906 0
School of Medical and Health Sciences, Edith Cowan University
Country [1] 303906 0
Australia
Primary sponsor type
University
Name
School of Medical and Health Sciences, Edith Cowan University
Address
School of Medical and Health Sciences
Edith Cowan University
Building 21, Room 21.501-I
270 Joondalup Drive
JOONDALUP WA 6027
Country
Australia
Secondary sponsor category [1] 304057 0
None
Name [1] 304057 0
Address [1] 304057 0
Country [1] 304057 0
Other collaborator category [1] 280968 0
Individual
Name [1] 280968 0
Associate Professor Mandy Stanley
Address [1] 280968 0
School of Medical and Health Sciences
Edith Cowan University
270 Joondalup Drive
JOONDALUP
WESTERN AUSTRALIA 6027
Country [1] 280968 0
Australia
Other collaborator category [2] 280969 0
Individual
Name [2] 280969 0
Professor Lisa Whitehead
Address [2] 280969 0
School of Nursing & Midwifery
Edith Cowan University
270 Joondalup Drive
JOONDALUP
WESTERN AUSTRALIA 6027
Country [2] 280969 0
Australia
Other collaborator category [3] 280970 0
Individual
Name [3] 280970 0
Ms Eimear Quigley
Address [3] 280970 0
Edith Cowan University
270 Joondalup Drive
JOONDALUP
WESTERN AUSTRALIA 6027
Country [3] 280970 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304412 0
ECU Human Research Ethics Committee
Ethics committee address [1] 304412 0
Ethics committee country [1] 304412 0
Australia
Date submitted for ethics approval [1] 304412 0
01/08/2019
Approval date [1] 304412 0
21/08/2019
Ethics approval number [1] 304412 0
STREAM 22000

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

Contacts
Principal investigator
Name 96862 0
Ms Yvonne Kutzer
Address 96862 0
School of Medical and Health Sciences
Edith Cowan University
Building 21, Room 21.501-I
270 Joondalup Drive
JOONDALUP WA 6027
Country 96862 0
Australia
Phone 96862 0
+61 8 6304 0000
Fax 96862 0
Email 96862 0
[email protected]
Contact person for public queries
Name 96863 0
Yvonne Kutzer
Address 96863 0
School of Medical and Health Sciences
Edith Cowan University
Building 21, Room 21.501-I
270 Joondalup Drive
JOONDALUP WA 6027
Country 96863 0
Australia
Phone 96863 0
+61 8 6304 0000
Fax 96863 0
Email 96863 0
[email protected]
Contact person for scientific queries
Name 96864 0
Yvonne Kutzer
Address 96864 0
School of Medical and Health Sciences
Edith Cowan University
Building 21, Room 21.501-I
270 Joondalup Drive
JOONDALUP WA 6027
Country 96864 0
Australia
Phone 96864 0
+61 8 6304 0000
Fax 96864 0
Email 96864 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
No consent obtained for data 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
EmbaseChanges in sleep effort mediate insomnia severity in older adults following online cognitive behavioural therapy.2024https://dx.doi.org/10.1111/psyg.13074
N.B. These documents automatically identified may not have been verified by the study sponsor.