Effect of Owning a Service Dog on Military Veterans With PTSD

Stress, Emotional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05208008
• Other study ID #: ANIMAL CONTACT 3
• Status: Recruiting
• Start date: January 17, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: University of Aarhus
• Contact: Karen Thodberg, PhD
• Phone: 93522604
• Email: karen.thodberg[@]anis.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Physiological Responses
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders
• Stress, Emotional

Intervention

Other:
• With service dog
No intervention

Locations

Country	Name	City	State
Denmark	Karen Thodberg	Højslev

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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