Effect of Owning a Service Dog on Military Veterans With PTSD

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT05208008
Collaborator
(none)
40
1
23.4
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
on the Daily Activity, Sleep Pattern, and Stress Level of Military Veterans With PTSD
Actual Study Start Date :
Jan 17, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Daily activity pattern [In the experimental period, which is 14 days]

    Daily activity pattern measured with a wrist-worn accelerometer

  2. Sleep pattern [In the experimental period, which is 14 days]

    Sleep pattern measured with a wrist-worn accelerometer

  3. Salivary, Cortisol [Day 1 of the experimental period at 11 a.m.]

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

  4. Salivary, Cortisol [Day 1 of the experimental period at 8 p.m.]

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

  5. Salivary, Cortisol [Day 2 of the experimental period at 11 a.m.]

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

  6. Salivary, Cortisol [Day 2 of the experimental period at 8 p.m.]

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

  7. Salivary, Cortisol [Day 3 of the experimental period at 11 a.m.]

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

  8. Salivary, Cortisol [Day 3 of the experimental period at 8 p.m.]

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

  9. Salivary, Cortisol [Day 4 of the experimental period at 11 a.m.]

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

  10. Salivary, Cortisol [Day 4 of the experimental period at 8 p.m.]

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

  11. Salivary, Cortisol [Day 5 of the experimental period at 11 a.m.]

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

  12. Salivary, Cortisol [Day 5 of the experimental period at 8 p.m.]

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

  13. Salivary, Cortisol [Day 6 of the experimental period at 11 a.m.]

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

  14. Salivary, Cortisol [Day 6 of the experimental period at 8 p.m.]

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

  15. Salivary, Cortisol [Day 7 of the experimental period at 11 a.m.]

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

  16. Salivary, Cortisol [Day 7 of the experimental period at 8 p.m.]

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

  17. Salivary, Cortisol [Day 8 of the experimental period at 11 a.m.]

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

  18. Salivary, Cortisol [Day 8 of the experimental period at 8 p.m.]

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

  19. Salivary, Cortisol [Day 9 of the experimental period at 11 a.m.]

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

  20. Salivary, Cortisol [Day 9 of the experimental period at 8 p.m.]

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

  21. Salivary, Cortisol [Day 10 of the experimental period at 11 a.m.]

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

  22. Salivary, Cortisol [Day 10 of the experimental period at 8 p.m.]

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

  23. Salivary, Cortisol [Day 11 of the experimental period at 11 a.m.]

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

  24. Salivary, Cortisol [Day 11 of the experimental period at 8 p.m.]

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

  25. Salivary, Cortisol [Day 12 of the experimental period at 11 a.m.]

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

  26. Salivary, Cortisol [Day 12 of the experimental period at 8 p.m.]

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

  27. Salivary, Cortisol [Day 13 of the experimental period at 11 a.m.]

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

  28. Salivary, Cortisol [Day 13 of the experimental period at 8 p.m.]

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

  29. Salivary, Cortisol [Day 14 of the experimental period at 11 a.m.]

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

  30. 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

  31. Blood pressure [Day 1 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  32. Blood pressure [Day 1 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  33. Blood pressure [Day 2 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  34. Blood pressure [Day 2 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  35. Blood pressure [Day 3 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  36. Blood pressure [Day 3 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  37. Blood pressure [Day 4 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  38. Blood pressure [Day 4 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  39. Blood pressure [Day 5 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  40. Blood pressure [Day 5 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  41. Blood pressure [Day 6 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  42. Blood pressure [Day 6 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  43. Blood pressure [Day 7 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  44. Blood pressure [Day 7 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  45. Blood pressure [Day 8 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  46. Blood pressure [Day 8 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  47. Blood pressure [Day 9 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  48. Blood pressure [Day 9 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  49. Blood pressure [Day 10 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  50. Blood pressure [Day 10 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  51. Blood pressure [Day 11 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  52. Blood pressure [Day 11 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  53. Blood pressure [Day 12 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  54. Blood pressure [Day 12 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  55. Blood pressure [Day 13 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  56. Blood pressure [Day 13 of the experimental period at 8 p.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  57. Blood pressure [Day 14 of the experimental period at 11 a.m.]

    Blood pressure is measured manually with a blood pressure monitor with a blood pressure cuff

  58. 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

  59. Heart rate [Day 2 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

  60. Heart rate [Day 4 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

  61. Heart rate [Day 6 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

  62. Heart rate [Day 8 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

  63. Heart rate [Day 10 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

  64. Heart rate [Day 12 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

  65. 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

  66. Heart rate variability [Day 2 of the experimental period]

    Heart rate variability is calculated from heart rate data

  67. Heart rate variability [Day 4 of the experimental period]

    Heart rate variability is calculated from heart rate data

  68. Heart rate variability [Day 6 of the experimental period]

    Heart rate variability is calculated from heart rate data

  69. Heart rate variability [Day 8 of the experimental period]

    Heart rate variability is calculated from heart rate data

  70. Heart rate variability [Day 10 of the experimental period]

    Heart rate variability is calculated from heart rate data

  71. Heart rate variability [Day 12 of the experimental period]

    Heart rate variability is calculated from heart rate data

  72. Heart rate variability [Day 14 of the experimental period]

    Heart rate variability is calculated from heart rate data

  73. Dairy notes regarding stressful events [Day 1 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

  74. Dairy notes regarding stressful events [Day 2 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

  75. Dairy notes regarding stressful events [Day 3 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

  76. Dairy notes regarding stressful events [Day 4 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

  77. Dairy notes regarding stressful events [Day 5 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

  78. Dairy notes regarding stressful events [Day 6 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

  79. Dairy notes regarding stressful events [Day 7 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

  80. Dairy notes regarding stressful events [Day 8 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

  81. Dairy notes regarding stressful events [Day 9 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

  82. Dairy notes regarding stressful events [Day 10 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

  83. Dairy notes regarding stressful events [Day 11 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

  84. Dairy notes regarding stressful events [Day 12 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

  85. Dairy notes regarding stressful events [Day 13 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

  86. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karen Thodberg HĂžjslev Denmark 7840

Sponsors and Collaborators

  • University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT05208008
Other Study ID Numbers:
  • ANIMAL CONTACT 3
First Posted:
Jan 26, 2022
Last Update Posted:
May 18, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Aarhus
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2022