Clinical trial NCT05208008: Effect of Owning a Service Dog on Military Veterans With PTSD
Official title: on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Physiological Responses
Sleep Disorders, Circadian Rhythm
Stress, Emotional
Keywords: Human-animal contact
Non-invasive measure
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Daily activity pattern
timeFrame: In the experimental period, which is 14 days
measure: Sleep pattern
timeFrame: In the experimental period, which is 14 days
measure: Salivary, Cortisol
timeFrame: Day 1 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 1 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 2 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 2 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 3 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 3 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 4 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 4 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 5 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 5 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 6 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 6 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 7 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 7 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 8 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 8 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 9 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 9 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 10 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 10 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 11 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 11 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 12 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 12 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 13 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 13 of the experimental period at 8 p.m.
measure: Salivary, Cortisol
timeFrame: Day 14 of the experimental period at 11 a.m.
measure: Salivary, Cortisol
timeFrame: Day 14 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 1 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 1 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 2 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 2 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 3 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 3 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 4 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 4 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 5 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 5 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 6 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 6 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 7 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 7 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 8 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 8 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 9 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 9 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 10 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 10 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 11 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 11 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 12 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 12 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 13 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 13 of the experimental period at 8 p.m.
measure: Blood pressure
timeFrame: Day 14 of the experimental period at 11 a.m.
measure: Blood pressure
timeFrame: Day 14 of the experimental period at 8 p.m.
measure: Heart rate
timeFrame: Day 2 of the experimental period
measure: Heart rate
timeFrame: Day 4 of the experimental period
measure: Heart rate
timeFrame: Day 6 of the experimental period
measure: Heart rate
timeFrame: Day 8 of the experimental period
measure: Heart rate
timeFrame: Day 10 of the experimental period
measure: Heart rate
timeFrame: Day 12 of the experimental period
measure: Heart rate
timeFrame: Day 14 of the experimental period
measure: Heart rate variability
timeFrame: Day 2 of the experimental period
measure: Heart rate variability
timeFrame: Day 4 of the experimental period
measure: Heart rate variability
timeFrame: Day 6 of the experimental period
measure: Heart rate variability
timeFrame: Day 8 of the experimental period
measure: Heart rate variability
timeFrame: Day 10 of the experimental period
measure: Heart rate variability
timeFrame: Day 12 of the experimental period
measure: Heart rate variability
timeFrame: Day 14 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 1 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 2 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 3 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 4 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 5 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 6 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 7 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 8 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 9 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 10 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 11 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 12 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 13 of the experimental period
measure: Dairy notes regarding stressful events
timeFrame: Day 14 of the experimental period
Secondary outcomes:
Other outcomes:
Locations:
city: Højslev
country: Denmark
facility: Karen Thodberg
Study officials:
References: