Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05208008
Other study ID # ANIMAL CONTACT 3
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 17, 2022
Est. completion date December 31, 2024

Study information

Verified date May 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
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 Active, not recruiting
Enrollment 40
Est. completion date December 31, 2024
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04064151 - A Research Study for Latina Women Undergoing Breast Cancer Treatment N/A
Recruiting NCT04160611 - What Amount of Stress is Enough for a Successful Conception? Phase 3
Completed NCT02947477 - Emotion Tracking Study for Residents N/A
Recruiting NCT05083871 - Cognitive Appraisals and Team Performance Under Stress in Simulated Trauma Care
Active, not recruiting NCT05092542 - Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers N/A
Completed NCT03464955 - VR Usage in Non-Invasive Surgical Sub-Specialty Procedures N/A
Completed NCT06152549 - Online Emotional Response to Completing a Childhood Maltreatment Self-report Scale
Completed NCT04977726 - Resilience Curriculum for Novice Physicians-in-training N/A
Active, not recruiting NCT04545021 - My Health Day by Day (Mi Salud Dia a Dia)
Not yet recruiting NCT05799534 - Post-Coronavirus Disease of 2019 (COVID-19) Rehabilitation Clinics in Saudi Arabia N/A
Not yet recruiting NCT04173559 - Sleep and Tracking Effects in Pregnancy Study N/A
Completed NCT04927845 - StriveWeekly Trial Post-pandemic N/A
Active, not recruiting NCT04950816 - Examining the Feasibility and Acceptability of a Tailored Version of a Mindfulness-Based Intervention (MBI) Among Youth Experiencing Homelessness (YEH) Phase 1
Completed NCT03645005 - A Research Study for Latina Women After Breast Cancer Treatment N/A
Completed NCT04595084 - Remotely Delivered Programs Targeting COVID-19 Stress-Related Depression and Substance Use N/A
Enrolling by invitation NCT06085105 - Caring for Providers to Improve Patient Experience (CPIPE) Trial N/A
Completed NCT05933746 - Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress N/A
Enrolling by invitation NCT06063174 - Stress & Resilience Study N/A
Completed NCT05304000 - Psychophysiological Effects of Controlled Respiration and Mindfulness N/A
Completed NCT04441632 - Effect of Positive Attitudes on Behavior and Wellness N/A