Effect of Owning a Service Dog on Military Veterans With PTSD
on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
1 other identifier
observational
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2021
CompletedStudy Start
First participant enrolled
January 17, 2022
CompletedFirst Posted
Study publicly available on registry
January 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 8, 2024
May 1, 2023
2 years
December 20, 2021
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (86)
Daily activity pattern
Daily activity pattern measured with a wrist-worn accelerometer
In the experimental period, which is 14 days
Sleep pattern
Sleep pattern measured with a wrist-worn accelerometer
In the experimental period, which is 14 days
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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
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
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
Heart rate variability
Heart rate variability is calculated from heart rate data
Day 2 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Day 4 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Day 6 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Day 8 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Day 10 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Day 12 of the experimental period
Heart rate variability
Heart rate variability is calculated from heart rate data
Day 14 of the experimental period
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Study Arms (2)
With service dog
Veterans living with a certified service dog
Without service dog
Veterans living without a certified service dog
Interventions
Eligibility Criteria
Military veterans, that either already ave a certified service dog, or are approved to receive a certified service dog, but on a waitlist. Furthermore, the military veterans should fulfill the inclusion criteria. The are recruited with help from the Danish Military, and the initial contact is established when potential participants respond to the advertisements by contacting of the scientific staff of the project.
You may qualify if:
- 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
You may not qualify if:
- Use of alcohol or drugs to an extent that it affects the ability to attend to ordinary daily activities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karen Thodberg
Højslev, 7840, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2021
First Posted
January 26, 2022
Study Start
January 17, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2024
Last Updated
May 8, 2024
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share