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Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD

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 : Enrolling by invitation
First Posted : August 10, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Marguerite O'Haire, Purdue University

Study Description
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Brief Summary:
The purpose of this study is to quantify the therapeutic efficacy and role of trained service dogs on socio-emotional functioning among military veterans with posttraumatic stress disorder (PTSD).

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Service Dog Not Applicable

Detailed Description:
The long-term research goal is to evaluate the safety and efficacy of service dogs as a complementary intervention to enhance biopsychosocial functioning in special populations. The objective is to conduct a methodologically rigorous trial to quantify the therapeutic efficacy of service dogs on clinically-important outcomes for veterans with PTSD. Based on preliminary findings and qualitative reports, the central hypothesis is that military veterans with PTSD who are provided service dogs will experience reduced PTSD symptoms related to socio-emotional functioning and arousal modulation. The rationale for this research is that its successful completion will provide an evidence-based demonstration of the efficacy and role of an increasingly used yet poorly tested complementary intervention. The completion of this project is expected to established an initial demonstration of the therapeutic efficacy of service dogs in this population, as well as possible mechanisms of action via specific biological pathways and human-canine interaction profiles.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Service Dog
Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. PTSD severity and symptoms via self-report [ Time Frame: 3 months ]
    Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)

  2. 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)

  3. Depression [ Time Frame: 3 months ]
    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a

  4. Anxiety [ Time Frame: 3 months ]
    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a


Secondary Outcome Measures :
  1. Social isolation [ Time Frame: 3 months ]
    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a

  2. Companionship [ Time Frame: 3 months ]
    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a

  3. 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

  4. Mental health quality of life [ Time Frame: 3 months ]
    Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component

  5. Psychological well-being [ Time Frame: 3 months ]
    Bradburn Scale of Psychological Wellbeing (BSPW)

  6. Life satisfaction [ Time Frame: 3 months ]
    Satisfaction with Life Scale (SLS)

  7. Resilience [ Time Frame: 3 months ]
    Connor-Davidson Resilience Scale (CDRS)

  8. Anger [ Time Frame: 3 months ]
    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a

  9. Daily socio-emotional experiences [ Time Frame: 3 months ]
    Ecological momentary assessment (EMA)


Other Outcome Measures:
  1. Work and activity participation [ Time Frame: 3 months ]
    Work Productivity and Activity Impairment Questionnaire (WPAIQ)

  2. Suicidal ideation [ Time Frame: 3 months ]
    Columbia Suicide Severity Rating Scale (CSSRS)

  3. Sleep quality [ Time Frame: 3 months ]
    Pittsburgh Sleep Quality Assessment (PSQI)

  4. Sleep disturbance [ Time Frame: 3 months ]
    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Sleep Disturbance 8a

  5. Sleep actigraphy [ Time Frame: 3 months ]
    Actiwatch 2 (Philips Respironics)

  6. Salivary cortisol awakening response [ Time Frame: 3 months ]
    Passive drool method (Salimetrics)

  7. Electrodermal activity (skin conductance) [ Time Frame: 3 months ]
    Embrace wristband (Empatica, Inc.)


Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Indiana
Purdue University
West Lafayette, Indiana, United States, 47907
Sponsors and Collaborators
Marguerite O'Haire
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Marguerite O'Haire, Ph.D. Purdue University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marguerite O'Haire, Purdue University:
service dogs
human-animal interaction
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders