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

• ClinicalTrials.gov Identifier: NCT03245814
• Recruitment Status: Completed
• First Posted: August 10, 2017
• Last Update Posted: March 11, 2021
• Sponsor: Marguerite O'Haire
• 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: July 5, 2017
• First Posted Date: August 10, 2017
• Last Update Posted Date: March 11, 2021
• Actual Study Start Date: July 1, 2017
• Actual Primary Completion Date: June 4, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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: 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: Quantifying the Efficacy and Role of Service Dogs for Military Veterans With PTSD
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Post Traumatic Stress Disorder

Intervention

Behavioral: Service Dog

A service dog trained to perform tasks that are specific to PTSD

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 10, 2021): 171
• Original Estimated Enrollment (submitted: August 7, 2017): 100
• Actual Study Completion Date: June 4, 2020
• Actual Primary Completion Date: June 4, 2020 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03245814
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Marguerite O'Haire, Purdue University
• Original Responsible Party: Same as current
• Current Study Sponsor: Marguerite O'Haire
• Original Study Sponsor: Same as current

Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• National Center for Complementary and Integrative Health (NCCIH)

Investigators

• Principal Investigator: Marguerite O'Haire, Ph.D.; Purdue University

• PRS Account: Purdue University
• Verification Date: March 2021