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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Stress, Emotional; Sleep Disorders, Circadian Rhythm; Physiological Responses
• Intervention / Treatment: Other: With service dog

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

Study Locations

• Denmark
  • Højslev, Denmark, 7840
    • Karen Thodberg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With service dog; Veterans living with a certified service dog	Other: With service dog; No intervention
Without service dog; Veterans living without a certified service dog

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Human-animal contact; Non-invasive measure
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Stress, Psychological; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: ANIMAL CONTACT 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No