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Completed

NCT Number: NCT03245814

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

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).

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Key information

Conditions

Post Traumatic Stress Disorder Behavior Human-Animal Interaction Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Service Dog

Behavioral

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

Primary outcomes

  1. PTSD Severity and Symptoms Via Self-report

    Time frame: 3 months

    Posttraumatic Stress Disorder Checklist for DSM-V (PCL-5); range 0-80; higher scores indicate worse outcome.

  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); range 0-80; higher scores indicate worse outcome.

  3. Depression

    Time frame: 3 months

    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Depression 8a; T-score range 38 to 81; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.

  4. Anxiety

    Time frame: 3 months

    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.0 - Emotional Distress - Anxiety 8a; T-score range 37 to 83; 50 indicates the population mean with a standard deviation of 10; minimally important difference greater than or equal to 3 points; higher scores indicate worse outcome.

Secondary outcomes

  1. Social Isolation

    Time frame: 3 months

    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Social Isolation 8a; T-score range 33 to 76; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.

  2. Companionship

    Time frame: 3 months

    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v2.0 - Companionship 6a; T-score range 24 to 64; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome

  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; T-score range 25 to 65; 50 indicates the population mean with a standard deviation of 10; higher scores indicate better outcome.

  4. Mental Health Quality of Life

    Time frame: 3 months

    Veterans Rand 12-item Health Survey (VR-12) - Mental Health Component; range 0-100; higher scores indicate better outcome.

  5. Psychological Well-being

    Time frame: 3 months

    Bradburn Scale of Psychological Wellbeing (BSPW); range -5 to 5; higher scores indicate better outcome.

  6. Life Satisfaction

    Time frame: 3 months

    Satisfaction with Life Scale (SLS); range 3-35; higher scores indicate better outcome.

  7. Resilience

    Time frame: 3 months

    Connor-Davidson Resilience Scale (CDRS); range 0-40; higher scores indicate better outcome.

  8. Anger

    Time frame: 3 months

    Patient Reported Outcome Measurement Information System (PROMIS) Adult Short Form (SF) v1.1 - Emotional Distress - Anger 5a; T-score range 32-82; 50 indicates the population mean with a standard deviation of 10; higher scores indicate worse outcome.

  9. Daily Socio-emotional Experiences

    Time frame: 3 months

    Ecological momentary assessment (EMA) Social interaction quality; range 0-6; higher score indicates better outcome.

Other outcomes

  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.)

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

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

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 10, 2017
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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