Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03245814 |
Recruitment Status :
Completed
First Posted : August 10, 2017
Last Update Posted : March 11, 2021
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Condition or disease | Intervention/treatment | Phase |
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Post Traumatic Stress Disorder | Behavioral: Service Dog | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 171 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Clinician Administered PTSD Scale for DSM-V (CAPS-5) assessments will be completed via telephone by a trained CAPS-5 rater who will be masked to the intervention and treatment arm of each participant. |
Primary Purpose: | Supportive Care |
Official Title: | Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD |
Actual Study Start Date : | July 1, 2017 |
Actual Primary Completion Date : | June 4, 2020 |
Actual Study Completion Date : | June 4, 2020 |

Arm | Intervention/treatment |
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Experimental: Service Dog
Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.
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Behavioral: Service Dog
A service dog trained to perform tasks that are specific to PTSD |
No Intervention: Waitlist Control
Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog.
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- PTSD severity and symptoms via self-report [ Time Frame: 3 months ]Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
- PTSD severity and symptoms via clinician rating [ Time Frame: 3 months ]Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5)
- Depression [ Time Frame: 3 months ]Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a
- Anxiety [ Time Frame: 3 months ]Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a
- Social isolation [ Time Frame: 3 months ]Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a
- Companionship [ Time Frame: 3 months ]Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a
- Ability to participate in social activities [ Time Frame: 3 months ]Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Ability to Participate in Social Roles and Activities 8a
- Mental health quality of life [ Time Frame: 3 months ]Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component
- Psychological well-being [ Time Frame: 3 months ]Bradburn Scale of Psychological Wellbeing (BSPW)
- Life satisfaction [ Time Frame: 3 months ]Satisfaction with Life Scale (SLS)
- Resilience [ Time Frame: 3 months ]Connor-Davidson Resilience Scale (CDRS)
- Anger [ Time Frame: 3 months ]Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a
- Daily socio-emotional experiences [ Time Frame: 3 months ]Ecological momentary assessment (EMA)
- Work and activity participation [ Time Frame: 3 months ]Work Productivity and Activity Impairment Questionnaire (WPAIQ)
- Suicidal ideation [ Time Frame: 3 months ]Columbia Suicide Severity Rating Scale (CSSRS)
- Sleep quality [ Time Frame: 3 months ]Pittsburgh Sleep Quality Assessment (PSQI)
- Sleep disturbance [ Time Frame: 3 months ]Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a
- Sleep actigraphy [ Time Frame: 3 months ]Actiwatch 2 (Philips Respironics)
- Salivary cortisol awakening response [ Time Frame: 3 months ]Passive drool method (Salimetrics)
- Electrodermal activity (skin conductance) [ Time Frame: 3 months ]Embrace wristband (Empatica, Inc.)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria for veterans into the study will include:
- Applied for and approved to receive a dog from K9s For Warriors
- Military service on or after September 11, 2001
- Honorable discharge or current honorable service
- Diagnosis of PTSD
- No conviction of any crimes against animals.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03245814
United States, Indiana | |
Purdue University | |
West Lafayette, Indiana, United States, 47907 |
Principal Investigator: | Marguerite O'Haire, Ph.D. | Purdue University |
Responsible Party: | Marguerite O'Haire, Assistant Professor of Human-Animal Interaction, Purdue University |
ClinicalTrials.gov Identifier: | NCT03245814 |
Other Study ID Numbers: |
1R21HD091896-01 ( U.S. NIH Grant/Contract ) R21HD091896-01 ( U.S. NIH Grant/Contract ) |
First Posted: | August 10, 2017 Key Record Dates |
Last Update Posted: | March 11, 2021 |
Last Verified: | March 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
service dogs human-animal interaction |
Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Trauma and Stressor Related Disorders Mental Disorders |