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

NCT03245814 | Completed Results DMC

• 2 other identifiers: 1R21HD091896-01R21HD091896-01
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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).

Conditions

Post Traumatic Stress Disorder

Keywords

service dogs; human-animal interaction

Outcome Measures

Primary Outcomes (4)

• PTSD Severity and Symptoms Via Self-report

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

  3 months

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

  3 months

• Depression

  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.

  3 months

• Anxiety

  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.

  3 months

Secondary Outcomes (9)

• Social Isolation

  3 months

• Companionship

  3 months

• Ability to Participate in Social Activities

  3 months

• Mental Health Quality of Life

  3 months

• Psychological Well-being

  3 months

Other Outcomes (7)

• Work and Activity Participation

  3 months

• Suicidal Ideation

  3 months

• Sleep Quality

  3 months

Study Arms (2)

Service Dog

EXPERIMENTAL

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

Behavioral: Service Dog

Waitlist Control

NO INTERVENTION

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

Interventions

Service Dog BEHAVIORAL

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

Service Dog

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Publications (2)

• Leighton SC, Rodriguez KE, Jensen CL, MacLean EL, Davis LW, Ashbeck EL, Bedrick EJ, O'Haire ME. Service Dogs for Veterans and Military Members With Posttraumatic Stress Disorder: A Nonrandomized Controlled Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414686. doi: 10.1001/jamanetworkopen.2024.14686.

  PMID: 38833250 DERIVED

• Leighton SC, Rodriguez KE, Zhuang R, Jensen CL, Miller EA, Sabbaghi A, O'Haire ME. Psychiatric service dog placements are associated with better daily psychosocial functioning for military veterans with posttraumatic stress disorder. Psychol Trauma. 2024 Dec;16(Suppl 3):S707-S717. doi: 10.1037/tra0001543. Epub 2023 Jul 6.

  PMID: 37410417 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Human-Animal Interaction

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Dr. Maggie O'Haire
• Organization: The University of Arizona

maggieohaire@arizona.edu

520-621-6767

Study Officials

• Marguerite O'Haire, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 5, 2017
• First Posted: August 10, 2017
• Study Start: July 1, 2017
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)