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

Primary Purpose

Post Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Service Dog
Sponsored by
Marguerite O'Haire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Post Traumatic Stress Disorder focused on measuring service dogs, human-animal interaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Purdue University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Service Dog

Waitlist Control

Arm Description

Participants in the service dog arm will receive unrestricted, non-study usual care, in addition to a trained service dog.

Participants in the control arm will receive unrestricted, non-study usual care, while on the waitlist for a service dog.

Outcomes

Primary Outcome Measures

PTSD severity and symptoms via self-report
Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5)
PTSD severity and symptoms via clinician rating
Clinician-Administered PTSD Assessment for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition DSM-V (CAPS-5)
Depression
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a
Anxiety
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a

Secondary Outcome Measures

Social isolation
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a
Companionship
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a
Ability to participate in social activities
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
Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component
Psychological well-being
Bradburn Scale of Psychological Wellbeing (BSPW)
Life satisfaction
Satisfaction with Life Scale (SLS)
Resilience
Connor-Davidson Resilience Scale (CDRS)
Anger
Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a
Daily socio-emotional experiences
Ecological momentary assessment (EMA)

Full Information

First Posted
July 5, 2017
Last Updated
March 10, 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)
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1. Study Identification

Unique Protocol Identification Number
NCT03245814
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
June 4, 2020 (Actual)
Study Completion Date
June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
service dogs, human-animal interaction

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Non-Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marguerite O'Haire, Ph.D.
Organizational Affiliation
Purdue University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Purdue University
City
West Lafayette
State/Province
Indiana
ZIP/Postal Code
47907
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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