Trial Outcomes & Findings for Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD (NCT NCT03245814)
NCT ID: NCT03245814
Last Updated: 2024-10-23
Results Overview
Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
170 participants
Primary outcome timeframe
3 months
Results posted on
2024-10-23
Participant Flow
Recruitment, eligibility screening, and enrollment occurred between July 2017 and December 2019. Veterans were recruited through the database of an accredited nonprofit service dog organization, K9s For Warriors.
Of 200 participants recruited and screened, 170 met inclusion criteria and were enrolled and allocated.
Participant milestones
| Measure |
Service Dog
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
79
|
|
Overall Study
Received Allocated Condition
|
81
|
75
|
|
Overall Study
COMPLETED
|
76
|
67
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
| Measure |
Service Dog
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
8
|
|
Overall Study
Excluded (did not receive allocated condition)
|
10
|
4
|
Baseline Characteristics
Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
Baseline characteristics by cohort
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 8.2 • n=39 Participants
|
38.2 years
STANDARD_DEVIATION 8.5 • n=41 Participants
|
37.6 years
STANDARD_DEVIATION 8.3 • n=35 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=39 Participants
|
22 Participants
n=41 Participants
|
39 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=39 Participants
|
53 Participants
n=41 Participants
|
117 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
30 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=39 Participants
|
59 Participants
n=41 Participants
|
121 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
62 Participants
n=39 Participants
|
55 Participants
n=41 Participants
|
117 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
81 participants
n=39 Participants
|
75 participants
n=41 Participants
|
156 participants
n=35 Participants
|
|
PTSD (PCL-5)
|
57.0 units on a scale
STANDARD_DEVIATION 11.3 • n=39 Participants
|
55.7 units on a scale
STANDARD_DEVIATION 14.3 • n=41 Participants
|
56.4 units on a scale
STANDARD_DEVIATION 12.8 • n=35 Participants
|
|
PTSD (CAPS-5)
|
42.0 units on a scale
STANDARD_DEVIATION 7.6 • n=39 Participants
|
40.0 units on a scale
STANDARD_DEVIATION 7.0 • n=41 Participants
|
41.1 units on a scale
STANDARD_DEVIATION 7.4 • n=35 Participants
|
|
Depression (PROMIS Depression)
|
64.9 T-score
STANDARD_DEVIATION 7.8 • n=39 Participants
|
62.7 T-score
STANDARD_DEVIATION 8.4 • n=41 Participants
|
63.8 T-score
STANDARD_DEVIATION 8.1 • n=35 Participants
|
|
Anxiety (PROMIS Anxiety)
|
68.2 T-score
STANDARD_DEVIATION 5.8 • n=39 Participants
|
66.5 T-score
STANDARD_DEVIATION 5.5 • n=41 Participants
|
67.4 T-score
STANDARD_DEVIATION 5.7 • n=35 Participants
|
|
PROMIS Social Isolation
|
65.3 T-score
STANDARD_DEVIATION 8.2 • n=39 Participants
|
62.7 T-score
STANDARD_DEVIATION 8.8 • n=41 Participants
|
64.1 T-score
STANDARD_DEVIATION 8.6 • n=35 Participants
|
|
PROMIS Companionship
|
44.9 T-score
STANDARD_DEVIATION 10.7 • n=39 Participants
|
46.9 T-score
STANDARD_DEVIATION 9.5 • n=41 Participants
|
45.9 T-score
STANDARD_DEVIATION 10.1 • n=35 Participants
|
|
PROMIS Social Activities
|
50.8 T-score
STANDARD_DEVIATION 8.2 • n=39 Participants
|
50.1 T-score
STANDARD_DEVIATION 6.3 • n=41 Participants
|
50.5 T-score
STANDARD_DEVIATION 7.3 • n=35 Participants
|
|
VR-12 MCS
|
26.0 units on a scale
STANDARD_DEVIATION 11.3 • n=39 Participants
|
28.2 units on a scale
STANDARD_DEVIATION 9.9 • n=41 Participants
|
27.1 units on a scale
STANDARD_DEVIATION 10.7 • n=35 Participants
|
|
BSPW
|
-2.7 units on a scale
STANDARD_DEVIATION 1.8 • n=39 Participants
|
-2.2 units on a scale
STANDARD_DEVIATION 1.9 • n=41 Participants
|
-2.4 units on a scale
STANDARD_DEVIATION 1.8 • n=35 Participants
|
|
SWLS
|
13.3 units on a scale
STANDARD_DEVIATION 6.3 • n=39 Participants
|
13.8 units on a scale
STANDARD_DEVIATION 6.6 • n=41 Participants
|
13.6 units on a scale
STANDARD_DEVIATION 6.4 • n=35 Participants
|
|
CD-RISC-10
|
17.5 units on a scale
STANDARD_DEVIATION 7.5 • n=39 Participants
|
20.8 units on a scale
STANDARD_DEVIATION 7.2 • n=41 Participants
|
19.1 units on a scale
STANDARD_DEVIATION 7.5 • n=35 Participants
|
|
PROMIS Anger
|
68.7 T-score
STANDARD_DEVIATION 9.1 • n=39 Participants
|
64.9 T-score
STANDARD_DEVIATION 8.7 • n=41 Participants
|
66.9 T-score
STANDARD_DEVIATION 9.0 • n=35 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPosttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
PTSD Severity and Symptoms Via Self-report
|
41.9 units on a scale
Standard Deviation 16.9
|
51.7 units on a scale
Standard Deviation 16.1
|
PRIMARY outcome
Timeframe: 3 monthsClinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5); range 0-80; higher scores indicate worse outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
PTSD Severity and Symptoms Via Clinician Rating
|
30.2 units on a scale
Standard Deviation 10.2
|
36.9 units on a scale
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: 3 monthsPatient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Depression
|
58.9 T-score
Standard Deviation 9.5
|
61.4 T-score
Standard Deviation 8.0
|
PRIMARY outcome
Timeframe: 3 monthsPatient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Anxiety
|
62.1 T-score
Standard Deviation 7.1
|
66.0 T-score
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: 3 monthsPatient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Social Isolation
|
60.1 T-score
Standard Deviation 10.8
|
62.8 T-score
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: 3 monthsPatient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Companionship
|
48.5 T-score
Standard Deviation 10.1
|
45.2 T-score
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: 3 monthsPatient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Ability to Participate in Social Activities
|
45.2 T-score
Standard Deviation 8.3
|
49.6 T-score
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: 3 monthsVeterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Mental Health Quality of Life
|
36.3 units on a scale
Standard Deviation 10.7
|
29.1 units on a scale
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 3 monthsBradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Psychological Well-being
|
-0.6 units on a scale
Standard Deviation 2.7
|
-2.2 units on a scale
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 3 monthsSatisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Life Satisfaction
|
19.7 units on a scale
Standard Deviation 7.0
|
15.3 units on a scale
Standard Deviation 6.9
|
SECONDARY outcome
Timeframe: 3 monthsConnor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Resilience
|
21.7 units on a scale
Standard Deviation 6.3
|
20.8 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: 3 monthsPatient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.
Outcome measures
| Measure |
Service Dog
n=81 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Anger
|
61.2 T-score
Standard Deviation 10.5
|
64.1 T-score
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: This analysis was conducted with all participants who had available data based on initial group assignment. It differs from the other analyses in that it was done prior to the primary outcomes analysis and does not follow the same modified intent-to-treat analysis as conducted with the other outcomes.
Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome.
Outcome measures
| Measure |
Service Dog
n=91 Participants
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=77 Participants
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Daily Socio-emotional Experiences
|
4.2 units on a scale
Standard Deviation 1.5
|
3.9 units on a scale
Standard Deviation 1.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsWork Productivity and Activity Impairment Questionnaire (WPAIQ)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsColumbia Suicide Severity Rating Scale (CSSRS)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPittsburgh Sleep Quality Assessment (PSQI)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPatient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsActiwatch 2 (Philips Respironics)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPassive drool method (Salimetrics)
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsEmbrace wristband (Empatica, Inc.)
Outcome measures
Outcome data not reported
Adverse Events
Service Dog
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Service Dog
n=81 participants at risk
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 participants at risk
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Surgical and medical procedures
Inpatient hospitalization
|
4.9%
4/81 • Number of events 4 • Adverse events were collected through passive surveillance. Participants spontaneously reported adverse events during study assessment periods (equivalent reporting opportunities across both groups) and during a 3-week on-site group class at the service dog organization (intervention group only).
|
8.0%
6/75 • Number of events 6 • Adverse events were collected through passive surveillance. Participants spontaneously reported adverse events during study assessment periods (equivalent reporting opportunities across both groups) and during a 3-week on-site group class at the service dog organization (intervention group only).
|
Other adverse events
| Measure |
Service Dog
n=81 participants at risk
Participants in the service dog arm received unrestricted, non-study usual care, in addition to a trained service dog.
Service Dog: A service dog trained to perform tasks that are specific to PTSD
|
Waitlist Control
n=75 participants at risk
Participants in the control arm received unrestricted, non-study usual care, while on the waitlist for a service dog.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Dog bite
|
1.2%
1/81 • Number of events 1 • Adverse events were collected through passive surveillance. Participants spontaneously reported adverse events during study assessment periods (equivalent reporting opportunities across both groups) and during a 3-week on-site group class at the service dog organization (intervention group only).
|
0.00%
0/75 • Adverse events were collected through passive surveillance. Participants spontaneously reported adverse events during study assessment periods (equivalent reporting opportunities across both groups) and during a 3-week on-site group class at the service dog organization (intervention group only).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place