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

Anxiety Clinical Trial

— Young-D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05555381
• Other study ID #: Young-D
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: September 30, 2025

Study information

• Verified date: September 2022
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

1. needs detection by means of survey and interviews

2. implementation of a 6 week program in day care facilities

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 30, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• diagnosed with early onset dementia before age of 65Y

Exclusion Criteria:

• severe dementia

Related Conditions & MeSH terms

• Alzheimer Disease
• Anxiety
• Anxiety Disorders
• Dementia
• Distress, Emotional
• Dyssomnias
• Insomnia
• Parasomnias
• Sleep
• Sleep Problem
• Sleep Wake Disorders
• Stress

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Belgium	Odisee University of Applied Sciences	Brussel	Flanders
Belgium	Familiezorg Oost Vlaanderen	Gent	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Odisee University college for applied sciences

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anxiety (GAD7 validated questionnaire)	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.	6 weeks
Primary	stress (perceived stress scale, PSS, validated questionnaire)	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.	6 weeks
Primary	sleep (Insomnia severity index, ISI, validated questionnaire)	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	6 weeks
Primary	sleep (actigraph)	this is an objective measurement that measures the sleep quantity	6 weeks
Secondary	emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)	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.	6 weeks
Secondary	quality of life (QoL) (quality of life in dementia, QUALIDEM)	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.	6 weeks
Secondary	heart rate variance (HRV)	this is an objective measurement that measures level of HRV in daily life, using (non-invasive photoplethysmography)	6 weeks
Secondary	Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)	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	6 weeks