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Trial registered on ANZCTR

Registration number

ACTRN12622000144718

Ethics application status

Approved

Date submitted

29/10/2021

Date registered

27/01/2022

Date last updated

17/03/2024

Date data sharing statement initially provided

27/01/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

The Dementia, Sleep and Wellbeing Study: targeting sleep and mood in people living with dementia and their care partners.

Scientific title

An open pilot feasibility trial of a multimodal sleep intervention on sleep disturbance in community-dwelling people living with mild dementia and primary care partners.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Dementia

Condition category

Condition code

Neurological

Dementias

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The developed intervention is therapist-assisted and multimodal, encompassing cognitive behavioural therapy for insomnia (CBT-I), mindfulness and light therapy (seeking natural light upon awakening, avoiding light at night) components to target sleep and mood in dyads of people with dementia and their primary care partner. There will be no use of external light therapy devices (e.g., glasses or light boxes).

Components will include: sleep education, stimulus control, sleep hygiene, strategies for fatigue and self-care, seeking or avoiding exposure to bright light, mindfulness (e.g., deep breathing and present-moment focus).

The focus of the intervention is on upskilling care partners in using strategies targeting their own sleep, including supporting the sleep of the person they are caring for. For this reason, it will not be required for the person living with dementia to attend all sessions apart from personalised dyad sessions. The group sessions are focused on strategies for care partners with there being the option to attend for the participants living with dementia.

• The intervention will consist of personalised dyad-only sessions and group-based delivery.
• All sessions will go for 60-90 minutes. Week 1 and 4: personalised dyad-only session; Week 2-3 and 5-6: small group-based sessions of care partners (optional attendance for people living with dementia). Ad hoc email support will be made available.
• In the personalised, dyad-only session in Week 1, the interventionist will assess unique sleep concerns of the dyad and deliver core components in light of these circumstances. In Week 4, there will be another personalised dyad-only session to overcome barriers and encourage adherence. The aims of the personalised sessions are to deliver pertinent strategies (e.g., sleep psychoeducation, stimulus control mindfulness), encourage adherence and personalise strategies in light of unique needs.

• The intervention will be delivered via Zoom. Personalised dyad-only sessions will focus on psychoeducation about sleep and discussing key strategies. The group sessions will focus on providing a reflective space to discuss strategies and share experiences of implementing strategies with other participants.
• It is expected participants will engage in sessions at their shared home.
• Sessions will be facilitated by a registered psychologist (minimum two years’ experience delivering CBT-I) and a provisional psychologist with supervision.
• Digital handouts (overview and reminders of key strategies) will be provided at the end of each session – these are specifically designed for the study.
• Adherence to intervention will be quantitatively (Client Satisfaction Questionnaire, self-rated helpfulness and usefulness of different strategies) and qualitatively (open feedback) assessed at post-intervention and one-month follow-up questionnaires. The psychologist will also check in regarding adherence each session to motivate participants in using strategies.

Intervention code [1]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

NIL - this is an open pilot trial with no control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

1. FEASIBILITY (Implementation) measured by:
a) % of sessions attended by carers (#/6)
b) Drop-out rate of carers

This is a composite primary outcome

Timepoint [1]

From Week 1 of intervention (week 3 following study commencement) to post-intervention i.e., 8 weeks post-commencement of study.

Primary outcome [2]

2. FEASIBILITY (Acceptability) measured by scores of carers (of at least 75%) on the Client Satisfaction Questionnaire (Attkisson & Zwick, 1982) in post-intervention questionnaire.

Timepoint [2]

Post-intervention (i.e., 8 weeks following commencement of study).

Secondary outcome [1]

PRELIMINARY EFFICACY (Sleep). This is a composite outcome measured by scores of CARERS:

1. Pittsburgh Sleep Quality Index
2. Sleep Disturbance Inventory (NOTE: this is a rating of sleep in the person with dementia)
3. Insomnia Severity Index
and
4. objectively-assessed sleep measured by actigraphy (sleep efficiency [%], sleep onset latency [mins], wake after sleep onset [mins]).

Timepoint [1]

Changes in scores from (week 2 following study commencement) to post-intervention (week 8 following commencement) for following variables (assessed in questionnaires):
1. Pittsburgh Sleep Quality Index
2. Sleep Disturbance Inventory
3. Insomnia Severity Index

Week 1-2 post=study commencement to weeks 7-8 following study commencement for Actigraphy.

Secondary outcome [2]

PRELIMINARY EFFICACY (Daytime impairment) measured by scores of carers on PROMIS Sleep Related Impairment

Timepoint [2]

Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires

Secondary outcome [3]

PRELIMINARY EFFICACY (Mood) assessed by CARER scores on
1. Depression, Anxiety and Stress Scale (DASS-21)
2. PROMIS Anxiety – SF – 8a
3. PROMIS Depression – SF – 8a

NOTE: This is a composite outcome

Timepoint [3]

Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires

Secondary outcome [4]

PRELIMINARY EFFICACY (CARER Quality of life) measured by carer scores on Health Questionnaire (EQ-5D-5L)a

Timepoint [4]

Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires

Secondary outcome [5]

PRELIMINARY EFFICACY (PERSON LIVING WITH DEMENTIA Quality of life) measured by The Alzheimer’s Disease-related Quality of Life scale (QoL-AD)*

Timepoint [5]

Changes in scores from baseline (week 2 following study commencement) to post-intervention (week 8 following commencement) assessed in questionnaires

Eligibility

Key inclusion criteria

PEOPLE LIVING WITH DEMENTIA:

a) Living with dementia (any form or severity);
b) Receives overnight support from care partner at least 3 times per week
c) Can provide informed consent or assent
d) Carer-reported sleep concerns (rated on a single-item statement)

CARE PARTNERS:
a) Self-report issues with their sleep (scores of 5 or more on the Pittsburgh Sleep Quality Index)
b) Living with and supporting a person with dementia at least three nights per week (responsible for providing overnight care when needed);
c) Able to communicate confidently in English;
d) Regular access to phone, email and internet;

Minimum age

35 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

PEOPLE LIVING WITH DEMENTIA:

a) Living in a residential care home
b) Have severe, untreated medical or physical conditions (e.g. emphysema, severe pain) that directly affect sleep
c) High risk of harm to self/others

CARE PARTNERS:
a) Severe untreated medical or physical conditions that directly affect sleep
b) Self-reported diagnosis of schizophrenia, bipolar disorder, PTSD) that directly impact sleep;
c) Fixed night shiftwork between midnight and 5 am, or rotating work schedules that require night shifts during participation.
d) A diagnosis of narcolepsy
e) High risk of harm to self/others

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

To get an idea of participants' baseline sleep characteristics, we will have a run-in period of 2 weeks in which they will use actigraphy (Phillips Respironics Actiwatch 2), complete a sleep diary and assess the Pittsburgh Sleep Quality Index (at the start of the 2 week period). PSQI will then be assessed in the main baseline questionnaire (along with other variables) to ensure participants continue to meet eligibility criteria.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

SAMPLE SIZE: Given the feasibility nature of this study, a convenience sample of 24 dyads will be recruited. This sample size is based on previous studies by the research team, which was deemed sufficient to trial the methodology as well as represent the diversity within dementia care.

FEASIBILITY: Evaluation of feasibility outcomes will be guided by the Consolidated Framework for Implementation Research (CFIR)20. It categorises barriers and enablers in five domains: intervention characteristics (e.g., complexity, cost), outer setting (e.g., home-based resources, barriers), inner setting (e.g., memory clinic implementation climate), characteristics of individuals (e.g., knowledge, beliefs), and implementation processes (e.g., execution, fidelity). CFIR offers a typology of determinants to support theory development about what works, where and why in the context of formative effectiveness-implementation randomised controlled trials.

PRELIMINARY EFFICACY: Changes in outcomes from baseline to post-intervention and post-intervention to follow-up will be assessed using repeated measures ANOVAs. Feasibility measures will be reported as standard scores.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

21/06/2022

Actual

27/06/2022

Date of last participant enrolment

Anticipated

Actual

29/06/2023

Date of last data collection

Anticipated

Actual

19/09/2023

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Dementia Centre for Research Collaboration

Address [1]

School of Psychology
University of New South Wales
Kensington
NSW 2052

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Wellington Road
Clayton VIC 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Monash University Human Ethics Research Committee (Monash Research Office)

Ethics committee address [1]

Room 116, Level 1
Chancellery Building D 
26 Sports Walk, Clayton Campus
Wellington Rd
Clayton VIC 3800, Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

18/10/2021

Approval date [1]

01/12/2021

Ethics approval number [1]

30710

Summary

Brief summary

This pilot study aims to test the feasibility of a non-pharmacological intervention to improve sleep and mood in care partners and people living with dementia. The developed intervention is multimodal and encompasses cognitive behavioural therapy for insomnia (first line of treatment for insomnia), mindfulness-based and fatigue management strategies to holistically target sleep and wellbeing in dyads. 24 dyads of people with dementia and carer partners (n=48) will engage in weekly sessions with a psychologist over six weeks. It is hypothesised that the sleep intervention will demonstrate appropriate: a) acceptability, implementation, and b) preliminary efficacy in reducing symptoms of sleep disturbance, insomnia, daytime impairment and mood disturbance (symptoms of depression and anxiety) and improving quality of life in people living with dementia and their carers from pre- to post-intervention.

Trial website

Trial related presentations / publications

Public notes

Sleep disturbance is common among people living with dementia and carers, and is associated with a wide range of undesirable outcomes including fatigue, agitation and cognitive dysfunction. Currently, accessible evidence-based interventions to reduce sleep disturbance among people with dementia and carers are limited, representing a significant gap in current research and clinical care. Cognitive Behavioural Therapy for Insomnia (CBT-I) is the gold standard treatment of insomnia and is highly effective in improving sleep. Digitally-delivered CBT-I is an effective alternative to face-to-face delivery, and is more cost-effective with potential to improve reach, which is particularly important in light of the COVID pandemic. This research project aims to pilot the feasibility of a novel, non-pharmacological intervention for people with dementia and their carer to improve sleep and mood. The developed intervention is multimodal and encompasses CBT-I, mindfulness-based and fatigue management strategies to holistically target sleep and wellbeing in dyads. 24 dyads of people with dementia and their carers (n=42) will engage in weekly sessions (up to 75 minutes) with a sleep psychologist over six weeks. Outcomes (including sleep, mood and fatigue) will be assessed pre- and post-intervention. 

If efficacious upon wider testing, this sleep intervention could dramatically transform how commonly experienced sleep disturbances are addressed in real world settings, which could benefit hundreds of thousands of Australians. This holds promise for future integration as an adjunct treatment option in clinical practice, and improving sleep health and wellbeing of both people with dementia and their carers.

Our study aims to test the feasibility of a collaborative sleep intervention for community-dwelling people with dementia and their primary carers to reduce. The intervention will include strategies for sleep, fatigue and relaxation based on cognitive behavioural therapy for insomnia, mindfulness and light therapy.

We will determine the a) acceptability b) implementation c) practicality and d) preliminary efficacy of the intervention in this population.

We have engaged two Community Advisors  with living experience of dementia or caregiving. Advisors provide feedback to promote sensible and sensitive research practices.

Contacts

Principal investigator

Name

Dr Melinda Jackson

Address

Monash University
18 Innovation walk
Clayton 3800
VICTORIA

Country

Australia

Phone

+61399050206

Fax

melinda.jackson@monash.edu

Contact person for public queries

Name

Melinda Jackson

Address

Monash University
18 Innovation walk
Clayton 3800
VICTORIA

Country

Australia

Phone

+61399050206

Fax

melinda.jackson@monash.edu

Contact person for scientific queries

Name

Melinda Jackson

Address

Monash University
18 Innovation walk
Clayton 3800
VICTORIA

Country

Australia

Phone

+61399050206

Fax

melinda.jackson@monash.edu

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

all of the individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

31/12/22 - 31/12/25

Available to whom?

Researchers upon reasonable request.

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Through Monash Bridges (online data repository).

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

Source	Title	Year of Publication	DOI
Embase	Multi-modal sleep intervention for community-dwelling people living with dementia and primary caregiver dyads with sleep disturbance: protocol of a single-arm feasibility trial.	2023	https://dx.doi.org/10.7717/peerj.16543

N.B. These documents automatically identified may not have been verified by the study sponsor.

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