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

Sponsor
KU Leuven (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05555381
Collaborator
Odisee University college for applied sciences (Other)
60
2
1
35
30
0.9

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: young-D program
N/A

Detailed Description

  1. needs detection by means of survey and interviews

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
Anticipated Study Start Date :
Nov 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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

  4. sleep (actigraph) [6 weeks]

    this is an objective measurement that measures the sleep quantity

Secondary Outcome Measures

  1. 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.

  2. 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.

  3. heart rate variance (HRV) [6 weeks]

    this is an objective measurement that measures level of HRV in daily life, using (non-invasive photoplethysmography)

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • diagnosed with early onset dementia before age of 65Y
Exclusion Criteria:
  • severe dementia

Contacts and Locations

Locations

Site City State Country Postal Code
1 Odisee University of Applied Sciences Brussel Flanders Belgium 1000
2 Familiezorg Oost Vlaanderen Gent Oost-Vlaanderen Belgium 9000

Sponsors and Collaborators

  • KU Leuven
  • Odisee University college for applied sciences

Investigators

  • Principal Investigator: Julie Vanderlinden, PhD, Odisee University of Applied Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Julie Vanderlinden, Principal investigator, KU Leuven
ClinicalTrials.gov Identifier:
NCT05555381
Other Study ID Numbers:
  • Young-D
First Posted:
Sep 26, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2022