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

Study Overview
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Brief Summary
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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
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needs detection by means of survey and interviews implementation of a 6 week program in day care facilities

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

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

Intervention / Treatment
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* Behavioral: young-D program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with early onset dementia before age of 65Y Exclusion Criteria: severe dementia
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group (pilot study)<br>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<br>* 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<br>|

What is the study measuring?
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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 |