Effect of Owning a Service Dog on Military Veterans With PTSD

N/AUnknownNCT05208008

University of Aarhus40 enrolled

Overview

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.

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

Conditions

Physiological Responses Sleep Disorders, Circadian Rhythm Stress, Emotional

Interventions

With service dogOTHER

No intervention

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Karen Thodberg

Højslev, Denmark

Outcomes

Primary Outcomes

Daily activity pattern

Daily activity pattern measured with a wrist-worn accelerometer

Time frame: In the experimental period, which is 14 days

Sleep pattern

Sleep pattern measured with a wrist-worn accelerometer

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day 3 of the experimental period at 8 p.m.

Data from ClinicalTrials.gov

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Salivary, Cortisol

Saliva is obtained from the testperson with a cotton swab which is chewed for one minute

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Day 14 of the experimental period at 8 p.m.

Blood pressure