Early Onset DementiaYoung-DNCT05555381
Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
A study testing young-D program in people with Early Onset Dementia and Young Onset Dementia, run by KU Leuven at 2 sites in Belgium.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Early Onset Dementia, Young Onset Dementia, Stress
- What is being tested?
- young-D program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Nov 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- diagnosed with early onset dementia before age of 65Y
Who cannot join
- severe dementia
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Odisee University of Applied Sciences
Brussel, Flanders, 1000
Julie Vanderlinden, phd, +3253727170, julie.vanderlinden@odisee.be
Familiezorg Oost Vlaanderen
Ghent, Oost-Vlaanderen, 9000
Julie Vanderlinden, 0478916956, julie.vanderlinden@odisee.be
About this study
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
Read the detailed description
- needs detection by means of survey and interviews
- implementation of a 6 week program in day care facilities
- Conditions
- Early Onset Dementia, Young Onset Dementia, Stress, Distress, Emotional, Anxiety, Sleep Problem
- Being tested
- young-D program
- Medical subject headings
- Anxiety Disorders, Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
young-D programBehavioural
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: young-D program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 6 weeks
sleep (actigraph)
this is an objective measurement that measures the sleep quantity
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 6 weeks
heart rate variance (HRV)
this is an objective measurement that measures level of HRV in daily life, using (non-invasive photoplethysmography)
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Onset DementiaStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Odisee University college for applied sciences
- Responsible party
- Principal investigator, Julie Vanderlinden, KU Leuven
- Investigators
- Julie Vanderlinden, PhD, Principal investigator, Odisee University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05555381
- Sponsor's protocol ID
- Young-D
- Acronym
- Young-D
- Status last verified
- Sep 2022
- First submitted
- 2 Jun 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety, Stress and Sleep Problems in People With Early Onset Dementia
- ClinicalTrials.gov ID
- NCT05555381
- Acronym / sponsor ID
- Young-D / Young-D
- Conditions
- Early Onset Dementia, Young Onset Dementia, Stress, Distress, Emotional, Anxiety, Sleep Problem
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Odisee University college for applied sciences
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- needs detection by means of survey and interviews
- implementation of a 6 week program in day care facilities
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group (pilot study) | Experimental | 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosed with early onset dementia before age of 65Y
Key exclusion criteria (1 listed)
- severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Intervention group (pilot study) |
Primary outcome
anxiety (GAD7 validated questionnaire)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 6 weeks
this is an objective measurement that measures the sleep quantity
4 secondary outcomes
emotional well being (WEMWBS, Warwick emotional mental wellbeing scale)
Time frame: 6 weeks
quality of life (QoL) (quality of life in dementia, QUALIDEM)
Time frame: 6 weeks
heart rate variance (HRV)
Time frame: 6 weeks
Depression (Patient Health Questionnaire PHQ-9, validated questionnaire)
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Vanderlinden, PhD principal investigator
Odisee University of Applied Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing young-D program in people with Early Onset Dementia and Young Onset Dementia, run by KU Leuven at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (GAD7 validated questionnaire) (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.