Trial Outcomes & Findings for Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD? (NCT NCT02039843)

NCT ID: NCT02039843

Last Updated: 2023-12-01

Results Overview

The World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) is a standardized measure for assessing health and disability levels. For the WHO-DAS 2.0 36-item, self-administered questionnaire, participants rate the difficulty they experience with each item on a 5-item scale: 'None,' 'Mild,' 'Moderate,' 'Severe' or 'Extreme/cannot do.' Standardized total disability scores ranging from 0 (no disability) to 100 (full disability) are obtained (WHO-DAS 2.0 manual, 2012).

Recruitment status

COMPLETED

Study phase

Target enrollment

287 participants

Primary outcome timeframe

Baseline and every 3 months after dog pairing up to 18 months post-pairing

Results posted on

2023-12-01

Participant Flow

Sixty participants of 287 consented participants were found to be ineligible for study randomization per study inclusion/exclusion criteria, resulting in 227 participants randomized.

Participant milestones

Participant milestones
Measure	Emotional Support Dog Participants with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs Participants with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Randomization and Observation Period STARTED	113	114
Randomization and Observation Period COMPLETED	84	97
Randomization and Observation Period NOT COMPLETED	29	17
Pairing With a Study Dog STARTED	84	97
Pairing With a Study Dog COMPLETED	65	88
Pairing With a Study Dog NOT COMPLETED	19	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Emotional Support Dog Participants with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs Participants with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Randomization and Observation Period Adverse Event	2	0
Randomization and Observation Period Death	1	0
Randomization and Observation Period Lost to Follow-up	2	3
Randomization and Observation Period Withdrawal by Subject	2	3
Randomization and Observation Period Other reasons not paired with a study dog	22	11
Pairing With a Study Dog Death	1	0
Pairing With a Study Dog Lost to Follow-up	1	4
Pairing With a Study Dog Withdrawal by Subject	4	1
Pairing With a Study Dog Other reasons for not completing study	13	4

Baseline Characteristics

The number analyzed is different from the analysis population due to one participant missing an assessment.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Emotional Support Dog n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).	Total n=181 Participants Total of all reporting groups
Age, Continuous	49.2 years STANDARD_DEVIATION 13.25 • n=84 Participants	51.8 years STANDARD_DEVIATION 13.87 • n=97 Participants	50.6 years STANDARD_DEVIATION 13.61 • n=181 Participants
Sex: Female, Male Female	14 Participants n=84 Participants	22 Participants n=97 Participants	36 Participants n=181 Participants
Sex: Female, Male Male	70 Participants n=84 Participants	75 Participants n=97 Participants	145 Participants n=181 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=84 Participants	4 Participants n=97 Participants	12 Participants n=181 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=84 Participants	91 Participants n=97 Participants	165 Participants n=181 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=84 Participants	2 Participants n=97 Participants	4 Participants n=181 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=84 Participants	1 Participants n=97 Participants	3 Participants n=181 Participants
Race (NIH/OMB) Asian	2 Participants n=84 Participants	0 Participants n=97 Participants	2 Participants n=181 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=84 Participants	1 Participants n=97 Participants	1 Participants n=181 Participants
Race (NIH/OMB) Black or African American	12 Participants n=84 Participants	10 Participants n=97 Participants	22 Participants n=181 Participants
Race (NIH/OMB) White	52 Participants n=84 Participants	68 Participants n=97 Participants	120 Participants n=181 Participants
Race (NIH/OMB) More than one race	15 Participants n=84 Participants	16 Participants n=97 Participants	31 Participants n=181 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=84 Participants	1 Participants n=97 Participants	2 Participants n=181 Participants
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0)	38.31 units on a scale STANDARD_DEVIATION 16.23 • n=83 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment.	35.78 units on a scale STANDARD_DEVIATION 16.72 • n=97 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment.	36.95 units on a scale STANDARD_DEVIATION 16.50 • n=180 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment.
Veterans Rand 12-Item Health Survey - Physical Component Score (VR-12 PCS)	40.16 T-score STANDARD_DEVIATION 9.94 • n=83 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment at baseline.	43.07 T-score STANDARD_DEVIATION 11.20 • n=97 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment at baseline.	41.73 T-score STANDARD_DEVIATION 10.71 • n=180 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment at baseline.
Veterans Rand 12-Item Health Survey - Mental Component Score (VR-12 MCS)	31.11 T-score STANDARD_DEVIATION 10.62 • n=83 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment at baseline.	30.68 T-score STANDARD_DEVIATION 10.37 • n=97 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment at baseline.	30.88 T-score STANDARD_DEVIATION 10.46 • n=180 Participants • The number analyzed is different from the analysis population due to one participant missing an assessment at baseline.

PRIMARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

Population: Participants randomized and paired with an emotional support dog or a service dog. The number of participants analyzed at each 3-month follow-up time point represents the number of individuals still participating in the study at that time point and completing the assessment. As this was a longitudinal study, attrition was expected and seen over time. Reasons for attrition are noted in the Participant Flow section under the 'Pairing With a Study Dog' Period.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score Month 15	43.48 score on a scale Standard Deviation 17.83	36.16 score on a scale Standard Deviation 17.69
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score Month 18	38.05 score on a scale Standard Deviation 17.79	33.43 score on a scale Standard Deviation 17.38
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score Baseline	38.31 score on a scale Standard Deviation 16.23	35.78 score on a scale Standard Deviation 16.72
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score Month 3	41.76 score on a scale Standard Deviation 16.89	38.76 score on a scale Standard Deviation 16.46
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score Month 6	41.70 score on a scale Standard Deviation 17.62	36.73 score on a scale Standard Deviation 16.33
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score Month 9	43.07 score on a scale Standard Deviation 18.74	36.90 score on a scale Standard Deviation 17.29
World Health Organization Disability Assessment Scale II (WHO-DAS 2.0) Total Score Month 12	40.79 score on a scale Standard Deviation 17.36	36.76 score on a scale Standard Deviation 17.23

PRIMARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The PCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) Baseline	40.16 T-score Standard Deviation 9.94	43.07 T-score Standard Deviation 11.20
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) Month 9	35.35 T-score Standard Deviation 11.32	39.07 T-score Standard Deviation 11.65
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) Month 18	37.30 T-score Standard Deviation 11.60	38.52 T-score Standard Deviation 11.71
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) Month 3	37.14 T-score Standard Deviation 10.86	39.05 T-score Standard Deviation 11.08
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) Month 6	35.78 T-score Standard Deviation 10.83	39.80 T-score Standard Deviation 11.59
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) Month 12	35.73 T-score Standard Deviation 12.52	38.89 T-score Standard Deviation 11.44
Veterans Rand 12-Item Health Survey (VR-12): Physical Component Score (PCS) Month 15	35.78 T-score Standard Deviation 11.42	39.48 T-score Standard Deviation 11.43

PRIMARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

The 12-item, self-administered Veterans Rand 12-Item Health Survey (VR-12) assesses health-related quality of life. Two sub-scores are derived: 1) a Physical Component Score (PCS) assessing general health, physical functioning, role limitations, and bodily pain; and 2) a Mental Component Score (MCS) assessing emotional, vitality/mental health and social functioning (Selim et al., 2009). The MCS score is standardized using a T-score transformation with a mean of 50 (which indicates the population mean) and a standard deviation (SD) of 10 to represent the population norm based on U.S. population in 1990. T-scores below 50 represent worse quality of life compared to the U.S. population norm, and those above 50 indicate better quality of life.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) Month 6	36.71 T-score Standard Deviation 11.30	35.71 T-score Standard Deviation 8.91
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) Month 18	39.04 T-score Standard Deviation 12.35	40.28 T-score Standard Deviation 9.33
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) Baseline	31.11 T-score Standard Deviation 10.62	30.68 T-score Standard Deviation 10.37
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) Month 3	35.59 T-score Standard Deviation 10.32	35.81 T-score Standard Deviation 9.07
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) Month 9	34.53 T-score Standard Deviation 10.59	36.39 T-score Standard Deviation 9.92
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) Month 12	37.32 T-score Standard Deviation 10.66	36.98 T-score Standard Deviation 10.83
Veterans Rand 12-Item Health Survey (VR-12): Mental Component Score (MCS) Month 15	36.42 T-score Standard Deviation 10.15	37.72 T-score Standard Deviation 11.40

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

The Pittsburgh Sleep Quality Index (PSQI) is a self-administered survey used to assess sleep-related problems during the past month (Buysse, et al., 1989). The 19 items completed by the participant are grouped into seven components: (1) Sleep quality, (2) Sleep latency, (3) Sleep duration, (4) Habitual sleep efficiency, (5) Sleep disturbances, (6) Use of sleep medication, and (7) Daytime dysfunction. Each of the seven components are weighted equally on a 0-3 scale with 0 (better) to 3 (worse). These are summed to yield a global score with a range of 0-21 with higher scores indicating worse sleep quality.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Pittsburgh Sleep Quality Index (PSQI) Global Score Month 15	12.91 score on a scale Standard Deviation 4.64	12.02 score on a scale Standard Deviation 4.50
Pittsburgh Sleep Quality Index (PSQI) Global Score Baseline	14.26 score on a scale Standard Deviation 4.09	13.60 score on a scale Standard Deviation 3.85
Pittsburgh Sleep Quality Index (PSQI) Global Score Month 3	13.60 score on a scale Standard Deviation 4.79	12.51 score on a scale Standard Deviation 4.24
Pittsburgh Sleep Quality Index (PSQI) Global Score Month 6	13.10 score on a scale Standard Deviation 4.60	12.17 score on a scale Standard Deviation 4.13
Pittsburgh Sleep Quality Index (PSQI) Global Score Month 9	13.29 score on a scale Standard Deviation 4.59	12.36 score on a scale Standard Deviation 4.37
Pittsburgh Sleep Quality Index (PSQI) Global Score Month 12	13.24 score on a scale Standard Deviation 4.88	12.27 score on a scale Standard Deviation 4.34
Pittsburgh Sleep Quality Index (PSQI) Global Score Month 18	12.54 score on a scale Standard Deviation 4.85	11.74 score on a scale Standard Deviation 4.33

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

The Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) is a 20-item self-report measure that assesses the 20 Diagnostic and Statistical Manual of Mental Disorder, 5th edition (DSM-5) symptoms of PTSD. Each symptom is scored on a scale of 0 (not at all) through 4 (extreme). A total symptom severity score is calculated by summing the scores for each of the 20 items. Scores can range from 0 to 80 with higher scores representing greater PTSD symptom severity.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score Month 3	41.96 score on a scale Standard Deviation 15.45	41.54 score on a scale Standard Deviation 15.14
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score Month 6	39.66 score on a scale Standard Deviation 16.43	39.39 score on a scale Standard Deviation 14.87
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score Month 9	41.04 score on a scale Standard Deviation 15.49	38.29 score on a scale Standard Deviation 15.04
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score Month 12	40.01 score on a scale Standard Deviation 17.60	35.48 score on a scale Standard Deviation 15.39
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score Month 15	41.23 score on a scale Standard Deviation 16.50	35.75 score on a scale Standard Deviation 16.18
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score Month 18	35.25 score on a scale Standard Deviation 17.00	31.66 score on a scale Standard Deviation 14.61
Post-Traumatic Stress Disorder (PTSD) Civilian Checklist 5 (PCL-5) Score Baseline	46.98 score on a scale Standard Deviation 14.70	48.33 score on a scale Standard Deviation 15.66

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

The Patient Health Questionnaire (PHQ-9) assesses the severity of depression (Kroenke, et al., 2002). It consists of 9 depression symptom questions with response choices of 0 (not at all), 1 (several days), 2 (more than half of days), or 3 (nearly every day). The total score is calculated by adding together the symptom ratings for each of the 9 questions so that scores range from 0 to 27 (higher scores represent greater depression severity).

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Patient Health Questionnaire (PHQ-9) Score Baseline	13.08 score on a scale Standard Deviation 5.94	12.79 score on a scale Standard Deviation 5.85
Patient Health Questionnaire (PHQ-9) Score Month 9	11.53 score on a scale Standard Deviation 6.18	9.52 score on a scale Standard Deviation 4.80
Patient Health Questionnaire (PHQ-9) Score Month 12	11.03 score on a scale Standard Deviation 6.31	9.97 score on a scale Standard Deviation 5.65
Patient Health Questionnaire (PHQ-9) Score Month 15	11.47 score on a scale Standard Deviation 6.20	9.67 score on a scale Standard Deviation 5.79
Patient Health Questionnaire (PHQ-9) Score Month 18	9.43 score on a scale Standard Deviation 6.24	8.19 score on a scale Standard Deviation 4.45
Patient Health Questionnaire (PHQ-9) Score Month 3	11.46 score on a scale Standard Deviation 6.05	10.95 score on a scale Standard Deviation 5.47
Patient Health Questionnaire (PHQ-9) Score Month 6	10.55 score on a scale Standard Deviation 6.03	10.03 score on a scale Standard Deviation 5.07

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

The 7-item Dimensions of Anger Reactions (DAR) is a seven-item scale that assesses anger disposition directed to others (Forbes, et al.,2004). For each item, participants indicate the degree to which each statement describes their feelings and behavior on an 8-point scale ranging from 0 (not at all) to 8 (exactly so). Scores are totaled yielding a range of 0 to 56 with higher scores indicating greater anger disposition.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Dimensions of Anger Reactions (DAR) Score Baseline	23.82 score on a scale Standard Deviation 14.64	21.85 score on a scale Standard Deviation 15.07
Dimensions of Anger Reactions (DAR) Score Month 3	23.21 score on a scale Standard Deviation 15.87	22.14 score on a scale Standard Deviation 14.28
Dimensions of Anger Reactions (DAR) Score Month 6	21.05 score on a scale Standard Deviation 16.32	20.35 score on a scale Standard Deviation 13.75
Dimensions of Anger Reactions (DAR) Score Month 9	23.97 score on a scale Standard Deviation 16.16	19.52 score on a scale Standard Deviation 13.22
Dimensions of Anger Reactions (DAR) Score Month 12	22.97 score on a scale Standard Deviation 15.57	18.58 score on a scale Standard Deviation 14.75
Dimensions of Anger Reactions (DAR) Score Month 15	22.32 score on a scale Standard Deviation 16.91	17.47 score on a scale Standard Deviation 14.24
Dimensions of Anger Reactions (DAR) Score Month 18	20.15 score on a scale Standard Deviation 16.63	15.90 score on a scale Standard Deviation 14.37

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

The Suicidal Behavior or Ideation (SBI) indicator derived from the Columbia Suicide Severity Rating Scale (C-SSRS) is dichotomized as the presence or absence of suicidal behavior or ideation. Presence of SBI is indicated by a "Yes" response to any one of the five suicidal behavior or the five suicidal ideation questions.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) Baseline	13 Participants	24 Participants
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) Month 3	22 Participants	33 Participants
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) Month 6	19 Participants	21 Participants
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) Month 9	19 Participants	22 Participants
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) Month 12	20 Participants	25 Participants
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) Month 15	21 Participants	20 Participants
Number of Participants Reporting Suicidal Behavior or Ideation (SBI) Derived From the Columbia Suicide Severity Rating Scale (C-SSRS) Month 18	18 Participants	13 Participants

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

Non-Veterans Administration (VA) healthcare utilization will be assessed using the "HERC non-VA utilization survey." This survey was created in 2011 by VA Health Economics Resource Center (HERC) investigators. The HERC non-VA utilization survey is self-administered and asks about outpatient and inpatient (including Emergency Room) visits to non-VA healthcare and/or non-VA mental health providers. Sample size (n) reflects the number of participants who provided self-reported non-VA healthcare use information at the time of data collection.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers Baseline	1.6 number of visits Standard Deviation 3.8	1.1 number of visits Standard Deviation 4.8
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers Month 3	0.9 number of visits Standard Deviation 2.6	0.5 number of visits Standard Deviation 1.3
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers Month 6	1.0 number of visits Standard Deviation 2.8	0.4 number of visits Standard Deviation 1.4
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers Month 9	1.3 number of visits Standard Deviation 3.5	0.5 number of visits Standard Deviation 1.5
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers Month 12	0.9 number of visits Standard Deviation 2.7	0.7 number of visits Standard Deviation 2.5
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers Month 15	1.4 number of visits Standard Deviation 3.3	0.5 number of visits Standard Deviation 1.5
Number of Outpatient Visits to Non-Veterans Administration (VA) Healthcare Providers or Mental Health Providers Month 18	0.9 number of visits Standard Deviation 2.1	0.6 number of visits Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities Month 3	0.1 number of visits Standard Deviation 0.3	0.0 number of visits Standard Deviation 0.2
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities Month 6	0.1 number of visits Standard Deviation 0.3	0.0 number of visits Standard Deviation 0.2
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities Baseline	0.1 number of visits Standard Deviation 0.4	0.1 number of visits Standard Deviation 0.3
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities Month 9	0.1 number of visits Standard Deviation 0.6	0.1 number of visits Standard Deviation 0.3
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities Month 12	0.1 number of visits Standard Deviation 0.4	0.1 number of visits Standard Deviation 0.3
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities Month 15	0.1 number of visits Standard Deviation 0.3	0.0 number of visits Standard Deviation 0.2
Number of Emergency Room Visits to Non-Veterans Administration (VA) Facilities Month 18	0.1 number of visits Standard Deviation 0.3	0.1 number of visits Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Percentage of Participants With a Non-VA Hospitalization Baseline	0 Percentage of participants Standard Deviation 0	6 Percentage of participants Standard Deviation 24
Percentage of Participants With a Non-VA Hospitalization Month 3	3 Percentage of participants Standard Deviation 16	5 Percentage of participants Standard Deviation 23
Percentage of Participants With a Non-VA Hospitalization Month 6	5 Percentage of participants Standard Deviation 23	2 Percentage of participants Standard Deviation 15
Percentage of Participants With a Non-VA Hospitalization Month 9	3 Percentage of participants Standard Deviation 17	8 Percentage of participants Standard Deviation 27
Percentage of Participants With a Non-VA Hospitalization Month 12	3 Percentage of participants Standard Deviation 17	3 Percentage of participants Standard Deviation 18
Percentage of Participants With a Non-VA Hospitalization Month 15	0 Percentage of participants Standard Deviation 0	1 Percentage of participants Standard Deviation 11
Percentage of Participants With a Non-VA Hospitalization Month 18	0 Percentage of participants Standard Deviation 0	2 Percentage of participants Standard Deviation 15

SECONDARY outcome

Timeframe: 540 days starting on the pairing date; summarized into six 90-day periods

Population: Participants randomized and paired with an emotional support dog or a service dog.

Utilization of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. Days 361-450	14.2 number of visits Standard Deviation 8.7	13.8 number of visits Standard Deviation 10.5
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. Days 451-540	14.8 number of visits Standard Deviation 10.7	13 number of visits Standard Deviation 9.8
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. Baseline (90 days prior to pairing)	16.4 number of visits Standard Deviation 9.1	15.2 number of visits Standard Deviation 10.6
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. Days 1-90	15.1 number of visits Standard Deviation 9.3	15.1 number of visits Standard Deviation 11.3
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. Days 91-180	14.5 number of visits Standard Deviation 9.1	15 number of visits Standard Deviation 9.8
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. Days 181-270	14.5 number of visits Standard Deviation 10.1	14.4 number of visits Standard Deviation 11.2
Number of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers. Days 271-360	13.4 number of visits Standard Deviation 8.5	13.4 number of visits Standard Deviation 9.8

SECONDARY outcome

Timeframe: 540 days starting on the pairing date; summarized into six 90-day periods

Population: Participants randomized and paired with an emotional support dog or a service dog

Utilization of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Baseline (90 days prior to pairing)	0 Number of inpatient admissions Standard Deviation 0.1	0.1 Number of inpatient admissions Standard Deviation 0.3
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 1-90	0 Number of inpatient admissions Standard Deviation 0.1	0.1 Number of inpatient admissions Standard Deviation 0.3
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 91-180	0 Number of inpatient admissions Standard Deviation 0.2	0 Number of inpatient admissions Standard Deviation 0.2
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 181-270	0 Number of inpatient admissions Standard Deviation 0.3	0.1 Number of inpatient admissions Standard Deviation 0.3
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 271-360	0 Number of inpatient admissions Standard Deviation 0.1	0 Number of inpatient admissions Standard Deviation 0.2
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 361-450	0.1 Number of inpatient admissions Standard Deviation 0.3	0.1 Number of inpatient admissions Standard Deviation 0.4
Number of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 451-540	0 Number of inpatient admissions Standard Deviation 0.3	0 Number of inpatient admissions Standard Deviation 0.1

SECONDARY outcome

Timeframe: 540 days starting on the pairing date; summarized into six 90-day periods

Population: Participants randomized and paired with an emotional support dog or a service dog

Cost of VA outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Baseline (90 days prior to pairing)	4701.32 U.S. dollars Standard Deviation 4714.98	4496.76 U.S. dollars Standard Deviation 4547.64
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 1-90	3997.82 U.S. dollars Standard Deviation 3433.71	4696.70 U.S. dollars Standard Deviation 4363.93
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 91-180	3684.87 U.S. dollars Standard Deviation 3295.50	4579.89 U.S. dollars Standard Deviation 4833.31
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 271-360	3494.07 U.S. dollars Standard Deviation 3840.25	4025.24 U.S. dollars Standard Deviation 4438.57
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 361-450	3762.58 U.S. dollars Standard Deviation 3886.48	4043.37 U.S. dollars Standard Deviation 4333.64
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 451-540	3685.47 U.S. dollars Standard Deviation 4648.30	3449.97 U.S. dollars Standard Deviation 4099.49
Total Cost of Outpatient Visits to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 181-270	3869.49 U.S. dollars Standard Deviation 4358.85	4360.64 U.S. dollars Standard Deviation 4602.07

SECONDARY outcome

Timeframe: 540 days starting on the pairing date; summarized into six 90-day periods

Population: Participants randomized and paired with an emotional support dog or a service dog

Cost of VA inpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Baseline (90 days prior to pairing)	184.53 U.S. dollars Standard Deviation 1701.29	1341.99 U.S. dollars Standard Deviation 7621.15
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 271-360	70.04 U.S. dollars Standard Deviation 456.89	1403.54 U.S. dollars Standard Deviation 6648.71
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 1-90	132.36 U.S. dollars Standard Deviation 1220.31	727.11 U.S. dollars Standard Deviation 3513.19
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 91-180	803.92 U.S. dollars Standard Deviation 5758.11	567.10 U.S. dollars Standard Deviation 3690.03
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 181-270	1182.46 U.S. dollars Standard Deviation 8807.28	1219.27 U.S. dollars Standard Deviation 8693.99
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days 361-450	916.85 U.S. dollars Standard Deviation 5527.54	1174.82 U.S. dollars Standard Deviation 6770.73
Total Cost of Inpatient Admissions to Veterans Administration (VA) Healthcare Providers or Mental Health Providers Days (451-540)	439.40 U.S. dollars Standard Deviation 2943.53	333.03 U.S. dollars Standard Deviation 2311.15

SECONDARY outcome

Timeframe: 540 days starting on the pairing date; summarized into six 90-day periods

Population: Participants randomized and paired with an emotional support dog or a service dog

Cost of VA inpatient and outpatient services, identified using VA administrative data. The investigators identified all VA utilization and cost data for the 540 days (i.e., 18 months) starting on the date of pairing for each participant and summarized the data into six 90-day periods.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Total Cost of VA Healthcare (Inpatient and Outpatient) Days 181-270	5051.95 U.S. dollars Standard Deviation 10019.56	5579.91 U.S. dollars Standard Deviation 9864.29
Total Cost of VA Healthcare (Inpatient and Outpatient) Days 271-360	3564.11 U.S. dollars Standard Deviation 3895.45	5428.78 U.S. dollars Standard Deviation 8514.41
Total Cost of VA Healthcare (Inpatient and Outpatient) Days 361-450	4679.42 U.S. dollars Standard Deviation 7081.99	5218.19 U.S. dollars Standard Deviation 8398.77
Total Cost of VA Healthcare (Inpatient and Outpatient) Days 451-540	4124.87 U.S. dollars Standard Deviation 6196.64	3782.99 U.S. dollars Standard Deviation 4929.90
Total Cost of VA Healthcare (Inpatient and Outpatient) Baseline (90 days prior to pairing)	4885.85 U.S. dollars Standard Deviation 5043.26	5838.74 U.S. dollars Standard Deviation 9613.11
Total Cost of VA Healthcare (Inpatient and Outpatient) Days 1-90	4130.18 U.S. dollars Standard Deviation 3637.66	5423.80 U.S. dollars Standard Deviation 6612.74
Total Cost of VA Healthcare (Inpatient and Outpatient) Days 91-180	4488.79 U.S. dollars Standard Deviation 7642.83	5146.99 U.S. dollars Standard Deviation 7084.47

SECONDARY outcome

Timeframe: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540

Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog

The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antidepressants are reported for this outcome (as a percentage).

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Percentage of Days Covered for Antidepressants Baseline	78.10 Percentage of days Standard Deviation 21.60	73.90 Percentage of days Standard Deviation 23.20
Percentage of Days Covered for Antidepressants Follow up	70.50 Percentage of days Standard Deviation 20.80	77.20 Percentage of days Standard Deviation 21.80

SECONDARY outcome

Timeframe: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540

Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog

The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for antipsychotics are reported for this outcome (as a percentage).

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Percentage of Days Covered for Antipsychotics Baseline	79.00 Percentage of days Standard Deviation 22.40	72.30 Percentage of days Standard Deviation 20.90
Percentage of Days Covered for Antipsychotics Follow up	71.40 Percentage of days Standard Deviation 28.50	76.30 Percentage of days Standard Deviation 17.40

SECONDARY outcome

Timeframe: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540

Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog

The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for benzodiazepines are reported for this outcome (as a percentage).

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Percentage of Days Covered for Benzodiazepines Follow up	54.80 Percentage of days Standard Deviation 28.30	60.10 Percentage of days Standard Deviation 29.30
Percentage of Days Covered for Benzodiazepines Baseline	61.60 Percentage of days Standard Deviation 25.60	72.60 Percentage of days Standard Deviation 26.60

SECONDARY outcome

Timeframe: Baseline: The 540 days prior to pairing Follow up: Pairing through day 540

Population: Participants with at least one refill in the drug class randomized and paired with an emotional support dog or a service dog

The investigators calculated Proportion of Days Covered (PDC) to measure medication adherence for common psychiatric medications dispensed by VA. Using the VA Drug Class variable, the investigators categorized medications into four categories: antidepressants (CN600-CN699), antipsychotics (CN700-CN799), benzodiazepine (CN302), and other hypnotics and sedatives (CN300, CN301, CN309). PDC for other sedatives are reported for this outcome (as a percentage).

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Percentage of Days Covered for Other Sedatives Baseline	66.90 Percentage of days Standard Deviation 30.90	63.20 Percentage of days Standard Deviation 25.30
Percentage of Days Covered for Other Sedatives Follow up	79.10 Percentage of days Standard Deviation 27.80	63.00 Percentage of days Standard Deviation 21.50

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

Population: Participants randomized and paired with an emotional support dog or a service dog

Employment assessed using the question "Are you currently employed (working for pay)?" from the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Sample size (n) reflects the number of participants who provided work productivity and employment information at the time of data collection.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Number of Veterans Employed Baseline	28 Participants	25 Participants
Number of Veterans Employed Month 3	27 Participants	22 Participants
Number of Veterans Employed Month 6	23 Participants	23 Participants
Number of Veterans Employed Month 9	20 Participants	22 Participants
Number of Veterans Employed Month 12	19 Participants	21 Participants
Number of Veterans Employed Month 15	18 Participants	25 Participants
Number of Veterans Employed Month 18	17 Participants	21 Participants

SECONDARY outcome

Timeframe: Baseline and every 3 months after dog pairing up to 18 months post-pairing

Population: Participants randomized and paired with an emotional support dog or a service dog

Impact of Health on Work Productivity was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health Problem V2.0 (WPAI V2.0; Reilly et al, 1993). Only participants who were employed were included in this analysis. Scores can range from 0 (no impact of health on work productivity) to 10 (extreme impact of health on work productivity), so a higher score represents a greater impact of health on work productivity.

Outcome measures

Outcome measures
Measure	Emotional Support Dogs n=84 Participants Participants paired with Emotional Support Dogs Emotional Support Dogs were required to pass the American Kennel Club Canine Good Citizen and the American Kennel Club Community Canine tests and be well-behaved and well-socialized.	Service Dogs n=97 Participants Participants paired with Service Dogs Service Dogs were required to pass the American Kennel Club Canine Good Citizen and the Assistance Dogs International Public Access tests and trained to complete five PTSD-specific tasks (lights, sweep, bring, block, \& behind).
Impact of Health on Work Productivity Score Baseline	5.7 score on a scale Standard Deviation 2.6	3.3 score on a scale Standard Deviation 2.2
Impact of Health on Work Productivity Score Month 9	3.9 score on a scale Standard Deviation 2.9	2.7 score on a scale Standard Deviation 2.8
Impact of Health on Work Productivity Score Month 12	3.1 score on a scale Standard Deviation 2.6	3.4 score on a scale Standard Deviation 2.6
Impact of Health on Work Productivity Score Month 18	2.7 score on a scale Standard Deviation 2.2	3.7 score on a scale Standard Deviation 2.3
Impact of Health on Work Productivity Score Month 3	4.7 score on a scale Standard Deviation 2.6	3.4 score on a scale Standard Deviation 2.8
Impact of Health on Work Productivity Score Month 6	4.1 score on a scale Standard Deviation 2.7	3.1 score on a scale Standard Deviation 2.9
Impact of Health on Work Productivity Score Month 15	3.6 score on a scale Standard Deviation 2.2	3 score on a scale Standard Deviation 2.9

Adverse Events

Emotional Support Dog

Serious events: 21 serious events

Other events: 5 other events

Deaths: 1 deaths

Service Dog

Serious events: 18 serious events

Other events: 0 other events

Deaths: 0 deaths

Prior to Dog Pairing

Serious events: 18 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Emotional Support Dog n=84 participants at risk Participants randomized and paired to receive an Emotional Support Dog Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.	Service Dog n=97 participants at risk Participants randomized and paired to receive a Service Dog Service Dog - an assistance dog specifically trained to perform tasks that are specific to the person's disability and has public access privileges.	Prior to Dog Pairing n=287 participants at risk All participants consented regardless of whether eventually randomized and paired with a dog.
Immune system disorders Allergy to animal	1.2% 1/84 • Number of events 1 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/97 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/287 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.
Infections and infestations Infestation	1.2% 1/84 • Number of events 1 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/97 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/287 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.
Injury, poisoning and procedural complications Animal bite	1.2% 1/84 • Number of events 2 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/97 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/287 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.
Injury, poisoning and procedural complications Fall	1.2% 1/84 • Number of events 1 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/97 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/287 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.
Injury, poisoning and procedural complications Joint injury	1.2% 1/84 • Number of events 1 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/97 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/287 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.
Injury, poisoning and procedural complications Limb injury	1.2% 1/84 • Number of events 1 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/97 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/287 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.
Psychiatric disorders Emotional distress	0.00% 0/84 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.00% 0/97 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.	0.35% 1/287 • Number of events 1 • Serious adverse events (SAE) were assessed continuously from the time of a participant's consent up to 19 months post-pairing (18 months post-pairing + 30 days). Other (non-SAE) adverse events were collected starting from dog pairing until up to 19 months post-pairing (18 months post-pairing + 30 days). For participants consented, all SAEs were collected. Other AEs were collected if possibly or definitely related to the intervention. Events AFTER pairing are reported under the randomized treatment group. Events BEFORE pairing are in the Prior to Dog Pairing group. Participants with an event in the Prior to Dog Pairing group may have an event reported in a treatment group. One SAE with a partial missing date is believed to have occurred prior to pairing and is in "Prior to Dog Pairing" group.

Additional Information

Joan Richerson

Tennesse Valley HCS

Phone: 615-574-8198

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place