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

Sumedha Verma; Prerna Varma; Aimee Brown; Bei Bei; Rosemary Gibson; Tom Valenta; Ann Pietsch; Marina Cavuoto; Michael Woodward; Susan McCurry; Melinda L Jackson

doi:10.7717/peerj.16543

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

PeerJ. 2023 Dec 14:11:e16543. doi: 10.7717/peerj.16543. eCollection 2023.

Authors

Sumedha Verma¹, Prerna Varma¹, Aimee Brown^{1

2}, Bei Bei¹, Rosemary Gibson³, Tom Valenta⁴, Ann Pietsch⁵, Marina Cavuoto¹, Michael Woodward⁶, Susan McCurry⁷, Melinda L Jackson¹

Affiliations

¹ Monash University, Clayton, Victoria, Australia.
² Monash-Epworth Rehabilitation Centre, Richmond, Victoria, Australia.
³ Health and Ageing Research Team, School of Psychology, Massey University, Palmerston North, New Zealand.
⁴ Independent Researcher, Melbourne, Victoria, Australia.
⁵ Independent Researcher, Adelaide, South Australia, Australia.
⁶ Aged and Continuing Care Services, Austin Health, Heidelberg, Victoria, Australia.
⁷ School of Nursing, University of Washington, Washington, United States of America.

Abstract

Background: Disturbed sleep is common among people living with dementia and their informal caregivers, and is associated with negative health outcomes. Dyadic, multi-modal interventions targeting caregiver and care-recipient sleep have been recommended yet remain limited. This protocol details the development of a single-arm feasibility trial of a multi-modal, therapist-led, six-week intervention targeting sleep disturbance in dyads of people living with dementia and their primary caregiver.

Methods: We aim to recruit 24 co-residing, community-dwelling dyads of people living with dementia and their primary informal caregiver (n = 48) with sleep concerns (Pittsburgh Sleep Quality Index ≥5 for caregivers, and caregiver-endorsed sleep concerns for the person living with dementia). People who live in residential care settings, are employed in night shift work, or are diagnosed with current, severe mental health conditions or narcolepsy, will be excluded. Participants will wear an actigraph and complete sleep diaries for two weeks prior, and during the last two weeks, of active intervention. The intervention is therapist-led and includes a mix of weekly small group video sessions and personalised, dyadic sessions (up to 90 min each) over six weeks. Sessions are supported by a 37-page workbook offering strategies and spaces for reflections/notes. Primary feasibility outcomes are caregiver: session attendance, attrition, and self-reported project satisfaction. Secondary outcomes include dyadic self-reported and objectively-assessed sleep, depression and anxiety symptoms, quality of life, and social support. Self-report outcomes will be assessed at pre- and post-intervention.

Discussion: If feasible, this intervention could be tested in a larger randomised controlled trial to investigate its efficacy, and, upon further testing, may potentially represent a non-pharmacological approach to reduce sleep disturbance among people living with dementia and their caregivers.

Anzctr trial registration: ACTRN12622000144718: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382960&showOriginal=true&isReview=true.

Keywords: Caregivers; Cognitive behavioural therapy; Dementia; Feasibility; Insomnia; Intervention.

Publication types

Clinical Trial Protocol

MeSH terms

Caregivers / psychology
Dementia* / therapy
Feasibility Studies
Humans
Independent Living
Quality of Life
Randomized Controlled Trials as Topic
Sleep
Sleep Wake Disorders* / therapy

Grants and funding

This trial was funded by the Dementia Centre for Research Collaboration—Pilot Grant Scheme 2020. The development and delivery of focus groups was funded by an internal Turner Institute Sleep and Circadian Theme Consumer and Community Involvement Grant. The official trial sponsor is Monash University. The funding source and sponsor had no role in design of the current study and will have no role in undertaking of the trial, including data analyses, interpretation, or decision to submit results. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.