Stress, Emotional Clinical Trial
Official title:
on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
The study aims to investigate the effects of a service dog on military veterans with post traumatic stress syndrome (PTSD). The investigators will use non-invasive measures of the physiological responses, data obtained via dairy keeping, accelerometer data estimating activity and sleep patterns, and baseline information including psychological measures validated for this specific population.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Have been deployed in a war zone - Fulfil criteria for PTSD - Fulfil criteria for receiving a certified service dog - If having a service dog, they must have owned the dog for more than 6 months, and the dog must be at leat 2 years of age Exclusion Criteria: - Use of alcohol or drugs to an extent that it affects the ability to attend to ordinary daily activities |
Country | Name | City | State |
---|---|---|---|
Denmark | Karen Thodberg | Højslev |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily activity pattern | Daily activity pattern measured with a wrist-worn accelerometer | In the experimental period, which is 14 days | |
Primary | Sleep pattern | Sleep pattern measured with a wrist-worn accelerometer | In the experimental period, which is 14 days | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 1 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 1 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 2 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 2 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 3 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 3 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 4 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 4 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 5 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 5 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 6 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 6 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 7 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 7 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 8 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 8 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 9 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 9 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 10 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 10 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 11 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 11 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 12 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 12 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 13 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 13 of the experimental period at 8 p.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 14 of the experimental period at 11 a.m. | |
Primary | Salivary, Cortisol | Saliva is obtained from the testperson with a cotton swab which is chewed for one minute | Day 14 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 1 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 1 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 2 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 2 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 3 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 3 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 4 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 4 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 5 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 5 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 6 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 6 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 7 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 7 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 8 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 8 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 9 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 9 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 10 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 10 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 11 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 11 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 12 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 12 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 13 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 13 of the experimental period at 8 p.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 14 of the experimental period at 11 a.m. | |
Primary | Blood pressure | Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff | Day 14 of the experimental period at 8 p.m. | |
Primary | Heart rate | The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively | Day 2 of the experimental period | |
Primary | Heart rate | The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively | Day 4 of the experimental period | |
Primary | Heart rate | The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively | Day 6 of the experimental period | |
Primary | Heart rate | The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively | Day 8 of the experimental period | |
Primary | Heart rate | The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively | Day 10 of the experimental period | |
Primary | Heart rate | The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively | Day 12 of the experimental period | |
Primary | Heart rate | The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively | Day 14 of the experimental period | |
Primary | Heart rate variability | Heart rate variability is calculated from heart rate data | Day 2 of the experimental period | |
Primary | Heart rate variability | Heart rate variability is calculated from heart rate data | Day 4 of the experimental period | |
Primary | Heart rate variability | Heart rate variability is calculated from heart rate data | Day 6 of the experimental period | |
Primary | Heart rate variability | Heart rate variability is calculated from heart rate data | Day 8 of the experimental period | |
Primary | Heart rate variability | Heart rate variability is calculated from heart rate data | Day 10 of the experimental period | |
Primary | Heart rate variability | Heart rate variability is calculated from heart rate data | Day 12 of the experimental period | |
Primary | Heart rate variability | Heart rate variability is calculated from heart rate data | Day 14 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 1 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 2 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 3 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 4 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 5 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 6 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 7 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 8 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 9 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 10 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 11 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 12 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 13 of the experimental period | |
Primary | Dairy notes regarding stressful events | The participant notes whether any situations, perceived to be stressful has happened, during each of the 14 days in the experimental peiod.during the experimental period | Day 14 of the experimental period |
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