Anxiety, Stress and Sleep Problems in People With Early Onset Dementia (Young-D)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Insomnia; Sleep; Anxiety; Distress, Emotional; Sleep Problem; Early Onset Dementia; Young Onset Dementia
• Intervention / Treatment: Behavioral: young-D program

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Flanders
    • Brussel, Flanders, Belgium, 1000
      • Odisee University of Applied Sciences
      • Contact: Julie Vanderlinden, phd; Phone Number: +3253727170; Email: julie.vanderlinden@odisee.be
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Familiezorg Oost Vlaanderen
      • Contact: Julie Vanderlinden; Phone Number: 0478916956; Email: julie.vanderlinden@odisee.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosed with early onset dementia before age of 65Y

Exclusion Criteria:

• severe dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (pilot study); 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
sleep (actigraph)	this is an objective measurement that measures the sleep quantity	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
heart rate variance (HRV)	this is an objective measurement that measures level of HRV in daily life, using (non-invasive photoplethysmography)	6 weeks
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

Collaborators and Investigators

• Sponsor: KU Leuven
• Collaborators: Odisee University college for applied sciences
• Investigators: Principal Investigator: Julie Vanderlinden, PhD, Odisee University of Applied Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2025

Study Registration Dates

• First Submitted: June 2, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 26, 2022
• Last Update Submitted That Met QC Criteria: September 23, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Sleep Wake Disorders; Anxiety Disorders; Dyssomnias; Parasomnias; Dementia; Alzheimer Disease
• Other Study ID Numbers: Young-D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No