Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000839606
Ethics application status
Approved
Date submitted
5/07/2023
Date registered
4/08/2023
Date last updated
16/06/2024
Date data sharing statement initially provided
4/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Mindfulness-based therapies for mood, insomnia and cognition in older adults
Scientific title
Efficacy of a digital mindfulness-based intervention in improving sleep, mood and cognition in older adults with subclinical and clinical symptoms of insomnia
Secondary ID [1] 309706 0
HREC ID: 38104
Universal Trial Number (UTN)
Trial acronym
MindMInC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 330462 0
Depression 330463 0
Anxiety 330464 0
Subjective Cognitive Complaints 330465 0
Condition category
Condition code
Mental Health 327315 327315 0 0
Other mental health disorders
Mental Health 327531 327531 0 0
Anxiety
Mental Health 327532 327532 0 0
Depression
Neurological 327533 327533 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be given access to a six-week online mindfulness-based insomnia intervention, called A Mindful Way to Healthy Sleep, delivered at the website www.amindfulway.com.au. The program involves a series of video lessons and modules teaching formal and informal mindfulness skills, and the components of cognitive behavioural therapy for insomnia. The mindfulness skills include deep breathing, abdominal breathing, body scan, guided reflection, visualization, and structured meditation. The course is led by Dr Giselle Withers, a clinical psychologist with experience in sleep psychology, and mindfulness teacher. Each module takes 1.5-2 hours each week and builds on the knowledge and homework from the previous week. As part of the homework, they will be asked to complete 15-30 minutes of daily meditation using audio recordings, make behavioural and cognitive changes as instructed during the course.

Adherence will be reviewed through percentage of course completed and a self-report questionnaire at end of study.
Intervention code [1] 326386 0
Treatment: Other
Intervention code [2] 326387 0
Lifestyle
Intervention code [3] 326388 0
Early detection / Screening
Comparator / control treatment
The control group will be given access to a six-week stepped-informational package regarding sleep health, hygiene and education via email. This will include informational text, diagrams and links to short videos. The initial component will cover psychoeducation around sleep, the science and evidence informing it and how it translates to sleep difficulty functionally. Building on this, participants will learn about ways to maintain basic sleep hygiene (e.g. monitor alcohol and caffeine intake, screen-time, light exposure etc.) to improve sleep habits. Finally, participants will be exposed to strategies around building a sustainable and healthy sleep routine, and receive further psychoeducation around links between sleep, ageing, mood and cognition. Thus, the emails will build on the information and activities done previously in each iteration.
After the 3-month follow-up, participants will be invited to the intervention arm, moving from an active control comparison to a waitlist-control methodology.
Control group
Active

Outcomes
Primary outcome [1] 335179 0
Change in symptoms of insomnia through Insomnia Severity Index (ISI)
Timepoint [1] 335179 0
At baseline and then at Week 6 post-baseline (primary), and 3, 6 and 12 months after program completion
Secondary outcome [1] 423397 0
Change in symptoms of depression measured through Patient Health Questionnaire-9 (PHQ-9)
Timepoint [1] 423397 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [2] 423398 0
Change in symptoms of anxiety measured through Generalised Anxiety Disorder-7 (GAD-7)
Timepoint [2] 423398 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [3] 423399 0
Change in Subjective Cognitive Complaints measured through study-specific questionnaire
Timepoint [3] 423399 0
At baseline and then at 3, 6 and 12 months after program completion
Secondary outcome [4] 423400 0
Change in positive affect through the Positive and Negative Affect Schedule (PANAS-SF)
Timepoint [4] 423400 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [5] 423401 0
Change in daytime sleepiness through Epworth Sleepiness Scale (ESS)
Timepoint [5] 423401 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [6] 423402 0
Change in sleep quality through Pittsburgh Sleep Quality Index (PSQI)
Timepoint [6] 423402 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [7] 423403 0
Change in pre-sleep arousal measured through the Pre-sleep Arousal Scale (PSAS)
Timepoint [7] 423403 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [8] 423405 0
Change in dysfunctional beliefs about sleep (DBAS)
Timepoint [8] 423405 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [9] 423406 0
Change in quality of life through the Older People's Quality of Life Questionnaire (OPQoL-brief)
Timepoint [9] 423406 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [10] 423606 0
Adherence to Mindfulness training through the Mindfulness Adherence Questionnaire (MAQ)
Timepoint [10] 423606 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [11] 423607 0
Mindfulness in daily life assessed through the Five-Facet Mindfulness Questionnaire (FFMQ-15)
Timepoint [11] 423607 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion
Secondary outcome [12] 424261 0
Change in negative affect through the Positive and Negative Affect Schedule (PANAS-SF)
Timepoint [12] 424261 0
At baseline and then at Week 6 post-baseline, and 3, 6 and 12 months after program completion

Eligibility
Key inclusion criteria
Older adults (aged 55+) with subclinical and clinical symptoms of sleep difficulty (ISI >= 8 or PSQI >=5) and mild to greater symptoms of depression or anxiety (GAD-7/PHQ-9 => 5) . Fluent in English, with adequate digital literacy who are able and willing to follow study protocols.
Minimum age
55 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current diagnosis of severe or high-risk psychiatric conditions (depressive, bipolar, schizophrenia/psychotic, substance-related, obsessive-compulsive, trauma-related and stressor-related disorders); neurodevelopmental disorders (dementia, intellectual disability or cognitive disorders such as traumatic brain injury); other untreated sleep disorders or an inability to complete the study at the judgement of the investigators

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified random allocation based on gender, subjective cognitive complaints and depression
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Participants divided into intervention and control group receive different treatment throughout the study. After 3-months, participants from control group will cross-over into the intervention arm
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
A-priori power analyses powered at (f = 0.3) and ß = 0.90 revealed 106 participants will need to be recruited for adequate power after accounting for attrition. Linear mixed models will be used for statistical analysis. Initially, each model will include the treatment group (MBTi vs SHHE) as a between-subjects factor, time (pre, post, 3-months, 6-month follow-up, 12-month follow-up) as a within-subjects categorical factor and the group-time interaction as fixed effects and participants as the random effect. Later, random slopes may also be added to understand if there is a difference in participant sensitivity to the treatment group. This is because participants from the community with mild to clinical presentations of insomnia, depression and anxiety will be recruited. As a result of this heterogeneity, it can be hypothesised that there will be lesser sensitivity to treatment for individuals with highly comorbid and chronic presentations.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/09/2023
Actual
20/10/2023
Date of last participant enrolment
Anticipated
31/08/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
106
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313899 0
Other Collaborative groups
Name [1] 313899 0
A Mindful Way to Healthy Sleep
Country [1] 313899 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University,
Wellington Rd,
Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 315753 0
None
Name [1] 315753 0
Address [1] 315753 0
Country [1] 315753 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313046 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 313046 0
Human Ethics Office
Monash University
Room 111, Chancellery Building E
24 Sports Walk, Clayton Campus, Wellington Rd, Clayton VIC 3800, Australia
Ethics committee country [1] 313046 0
Australia
Date submitted for ethics approval [1] 313046 0
08/06/2023
Approval date [1] 313046 0
24/07/2023
Ethics approval number [1] 313046 0
38104

Summary
Brief summary
Difficulties getting to sleep, staying asleep and waking up too early, characterising insomnia, are widely prevalent in aging populations, with over 30-48% older adults reporting sleep issues. Sleep problems are often left untreated as it is viewed as part of
the normal ageing process. Further, there are many barriers such as long waitlists, high financial costs and limited availability of trained service providers to accessing first-line treatments to insomnia like cognitive-behavioural therapy for insomnia (CBTi).
Moreover, CBTi is found ineffective for 30-40% of the population. Thus, there is a critical need for alternative and accessible interventions to reduce the high health and financial burden that insomnia in older adults causes. Mindfulness-based therapy for insomnia (MBTi) which potentially targets both the cognitive arousal (e.g. dysfunctional beliefs about sleep) and metacognitive processes (e.g. bias in attention to sleep-related thoughts) that maintain insomnia may be a feasible alternative. MBTi has also been linked to improvements in mood and cognitive functioning. Overall, MBTi may have high clinical utility for older adults by reducing the cognitive-emotional arousal caused by aging and its related comorbidities. Further digitally-delivered MBTi in older adults have yet to
be tested.
A feasible, online intervention could potentially become a widely-disseminable, financially accessible and effective treatment for older adults. This would reduce the pressure on limited face-to-face service providers and allow a stepped-care approach to
treatment.
Trial website
https://basemindfulsleep.wixsite.com/mindminc-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126802 0
Dr Melinda Jackson
Address 126802 0
18 Innovation Walk, Monash University,
Clayton VIC 3800, Australia
Country 126802 0
Australia
Phone 126802 0
+61 03 99050206
Fax 126802 0
Email 126802 0
[email protected]
Contact person for public queries
Name 126803 0
Miss Hemangi Sanjivini
Address 126803 0
18 Innovation Walk, Monash University,
Clayton VIC 3800, Australia
Country 126803 0
Australia
Phone 126803 0
+61 03 99050206
Fax 126803 0
Email 126803 0
[email protected]
Contact person for scientific queries
Name 126804 0
Miss Hemangi Sanjivini
Address 126804 0
18 Innovation Walk, Monash University,
Clayton VIC 3800, Australia
Country 126804 0
Australia
Phone 126804 0
+61 03 99050206
Fax 126804 0
Email 126804 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


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
No additional documents have been identified.