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

NCT05555381 | Unknown DMC

• 1 other identifier: Young-D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)

  6 weeks

• quality of life (QoL) (quality of life in dementia, QUALIDEM)

  6 weeks

• heart rate variance (HRV)

  6 weeks

• Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)

  6 weeks

Study Arms (1)

Intervention group (pilot study)

EXPERIMENTAL

* 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

Interventions

young-D program BEHAVIORAL

* 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

Intervention group (pilot study)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosed with early onset dementia before age of 65Y

You may not qualify if:

• severe dementia

Sponsors & Collaborators

• KU Leuven: lead
• Odisee University college for applied sciences: collaborator

Study Sites (2)

Odisee University of Applied Sciences

Brussel, Flanders, 1000, Belgium

Location

Familiezorg Oost Vlaanderen

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

MeSH Terms

Conditions

Anxiety Disorders; Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Wake Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Study Officials

• Julie Vanderlinden, PhD

  Odisee University of Applied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: September 26, 2022
• Study Start: November 1, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: September 26, 2022

Record last verified: 2022-09

Locations

BE (2)