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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

Tracking Information
First Submitted Date  ICMJE July 5, 2017
First Posted Date  ICMJE August 10, 2017
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2017)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
  • 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 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2017)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 7, 2017)
  • 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.)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
Official Title  ICMJE Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Post Traumatic Stress Disorder
Intervention  ICMJE Behavioral: Service Dog
A service dog trained to perform tasks that are specific to PTSD
Study Arms  ICMJE
  • Experimental: Service Dog
    Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.
    Intervention: Behavioral: Service Dog
  • No Intervention: Waitlist Control
    Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: August 7, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03245814
Other Study ID Numbers  ICMJE 1R21HD091896-01( U.S. NIH Grant/Contract )
R21HD091896-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marguerite O'Haire, Purdue University
Study Sponsor  ICMJE Marguerite O'Haire
Collaborators  ICMJE
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Complementary and Integrative Health (NCCIH)
Investigators  ICMJE
Principal Investigator: Marguerite O'Haire, Ph.D. Purdue University
PRS Account Purdue University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP