Effect of Owning a Service Dog on Military Veterans With PTSD

Study Overview
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Brief Summary
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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.

Detailed Description
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The investigators will measure and compare the immediate effect of the presence of the dog, on days with low stress and high stress, using non-invasive measures of the physiological response, diary notes, and data on activity and sleep pattern The latter will also be collected for the service dogs. The investigators will apply a cross-sectional design. The participants will be divided into two groups based on whether they own a certified service dog (treatment group) or are on a waitlist for a service dog (control group). The experimental period will consist of a 14-day period. In the preceding week the participants receive a visit, where they will be given instructions to fill in a diary, how to collect and store saliva samples, and use equipment for data collection. In the diary they record their daily activities and any situation perceived to be stressful during the experimental period. In the experimental period, the participants will wear an accelerometer. Every second day, the particpants will wear equipment measuring their heart rate.

Official Title
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on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD

Conditions
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Physiological Responses, Sleep Disorders, Circadian Rhythm, Stress, Emotional

Intervention / Treatment
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* Other: With service dog


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With service dog<br>Veterans living with a certified service dog | Other: With service dog<br>* No intervention<br>|
| Without service dog<br>Veterans living without a certified service dog | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Human-animal contact, Non-invasive measure