Effect of Owning a Service Dog on Military Veterans With PTSD

Active, not recruiting

• Conditions: Physiological Responses; Stress, Emotional; Sleep Disorders, Circadian Rhythm
• Interventions: Other: With service dog

• Registration Number: NCT05208008
• Lead Sponsor: University of Aarhus

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.

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 Timeline

• Study First Submitted: 2021-12-20
• Study First Submitted QC: 2022-01-12
• Study Start: 2022-01-17
• Study First Posted: 2022-01-26
• Status Verified: 2023-05
• Primary Completion: 2023-12-31
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With service dog	With service dog	Veterans living with a certified service dog

Primary Outcome Measures

Name	Time	Method
Heart rate variability	Day 14 of the experimental period	Heart rate variability is calculated from heart rate data
Blood pressure	Day 14 of the experimental period at 8 p.m.	Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff
Dairy notes regarding stressful events	Day 14 of the experimental period	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
Salivary, Cortisol	Day 14 of the experimental period at 8 p.m.	Saliva is obtained from the testperson with a cotton swab which is chewed for one minute
Daily activity pattern	In the experimental period, which is 14 days	Daily activity pattern measured with a wrist-worn accelerometer
Heart rate	Day 14 of the experimental period	The test person wears either self-adhesive electrodes or a belt around their chest and the heart rate is measured non-invasively
Sleep pattern	In the experimental period, which is 14 days	Sleep pattern measured with a wrist-worn accelerometer

Trial Locations

Locations (1)

Karen Thodberg; 🇩🇰 Højslev, Denmark