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

Not Applicable

Not yet recruiting

• Conditions: Young Onset Dementia; Stress; Insomnia; Sleep Problem; Early Onset Dementia; Distress, Emotional; Anxiety; Sleep
• Interventions: Behavioral: young-D program

• Registration Number: NCT05555381
• Lead Sponsor: KU Leuven

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

Study Timeline

• Study First Submitted: 2022-06-02
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-23
• Last Update Submitted: 2022-09-23
• Study First Posted: 2022-09-26
• Last Update Posted: 2022-09-26
• Study Start: 2022-11-01
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• diagnosed with early onset dementia before age of 65Y

Exclusion Criteria

• severe dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group (pilot study)	young-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

Primary Outcome Measures

Name	Time	Method
anxiety (GAD7 validated questionnaire)	6 weeks	this 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 weeks	this 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 weeks	this 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
sleep (actigraph)	6 weeks	this is an objective measurement that measures the sleep quantity

Secondary Outcome Measures

Name	Time	Method
emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)	6 weeks	this 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 weeks	this 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 weeks	this 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 weeks	this 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

Trial Locations

Locations (2)

Odisee University of Applied Sciences; 🇧🇪 Brussel, Flanders, Belgium

Familiezorg Oost Vlaanderen; 🇧🇪 Gent, Oost-Vlaanderen, Belgium