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Anxiety, Stress and Sleep Problems in People With Early Onset Dementia

Anxiety, Stress and Sleep Problems in People With Early Onset Dementia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05555381
Acronym
Young-D
Enrollment
60
Registered
2022-09-26
Start date
2022-11-01
Completion date
2025-09-30
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Distress, Emotional, Early Onset Dementia, Insomnia, Sleep, Sleep Problem, Stress, Young Onset Dementia

Brief summary

The aim of this study is to * detect and assess needs of people with early onset dementia regarding anxiety, stress and sleep * implement a 6 week intervention pilot study in wich weekly (hourly) sessions are implemented in day care settings in order to decrease anxiety, stress and sleep problems in people with early onset dementia

Detailed description

1. needs detection by means of survey and interviews 2. implementation of a 6 week program in day care facilities

Interventions

BEHAVIORALyoung-D program

* needs detection by means of survey and interviews (mixed-methods) * 6 week program (1 hour) on a weekly basis including cognitive behavioural therapy, sleep/stress hygiene education, heart coherence exercises, mindfulness and relaxation exercises

Sponsors

Odisee University college for applied sciences
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* diagnosed with early onset dementia before age of 65Y

Exclusion criteria

* severe dementia

Design outcomes

Primary

MeasureTime frameDescription
sleep (actigraph)6 weeksthis is an objective measurement that measures the sleep quantity
anxiety (GAD7 validated questionnaire)6 weeksthis is a subjective survey that measures the level of anxiety in daily life. It is a score of 7 items with a min of 0 and a max of 21. A higher score indicates a higher anxiety.
stress (perceived stress scale, PSS, validated questionnaire)6 weeksthis is a subjective survey that measures the level of stress in daily life. It is a score of 10 items with a min of 0 and a max of 40. A higher score indicates a higher stress level.
sleep (Insomnia severity index, ISI, validated questionnaire)6 weeksthis is a subjective survey that measures the level of insomnia. It is a score of 7 items with a min of 0 and a max of 28. A higher score indicates a worse level of insomnia

Secondary

MeasureTime frameDescription
emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)6 weeksthis is a subjective survey that measures the level of emotional well being in daily life. It is a score of14 items with a min of 0 and a max of 77. A higher score indicates a better wellbeing.
quality of life (QoL) (quality of life in dementia, QUALIDEM)6 weeksthis is a subjective survey that measures the level of QoL in daily life. It is a score of 40 items with a min of 0 and a max of 160. Per (7) subscales the scores are cumulated.
heart rate variance (HRV)6 weeksthis is an objective measurement that measures level of HRV in daily life, using (non-invasive photoplethysmography)
Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)6 weeksthis is a subjective survey that measures the level of depression in daily life. It is a score of 10 items with a min of 0 and a max of 27. A higher score indicates a more severe level of depression

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026