Service Dogs for Veterans With PTSD

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01329341
First received: March 30, 2011
Last updated: May 11, 2015
Last verified: May 2015

March 30, 2011
May 11, 2015
July 2011
January 2017   (final data collection date for primary outcome measure)
Mental Health Outcomes [ Time Frame: 3,6,9,12,18 and 24 months after receipt of service dog ] [ Designated as safety issue: No ]
Mental Health Outcomes are defined by the following measures: (PCL-S - PTSD symptoms; Depression - measured by PHQ9; and Alcohol abuse - measured by the Audit-C)
Mental Health Outcomes [ Time Frame: 3,6,9,12,18 and 24 months after receipt of service dog ] [ Designated as safety issue: No ]
Mental Health Outcomes are defined by the following measures: (CAPS & PCL-C - PTSD diagnosis; Depression - measured by PHQ9; Anxiety - measured by STATE/TRAIT) and Alcohol abuse - measured by the Audit-C)
Complete list of historical versions of study NCT01329341 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Service Dogs for Veterans With PTSD
Service Dogs for Veterans With PTSD: A Randomized Clinical Trial

The purpose of this study is to evaluate use of service dogs for individuals who have been diagnosed with Post Traumatic Stress Disorder (PTSD). Objectives include: (1) assess the impact service dogs have on the mental health and quality of life of Veterans; (2) to provide recommendations to the VA to serve as guidance in providing service dogs to veterans; and (3) To determine cost associated with total health care utilization and mental health care utilization among veterans with PTSD.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
PTSD
Other: Service Dogs
Service dogs will be trained to help veterans with PTSD
Other Name: Service Dogs
Experimental: Arm 1
Service Dogs
Intervention: Other: Service Dogs
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
220
October 2017
January 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Referral from provider.
  • PTSD diagnosis
  • In active treatment for PTSD for at least three months at time of enrollment, with plans to remain in active treatment
  • Acceptance by the dog vendor for the service dog
  • Ability to adequately care for a dog - physically/financially
  • Living in Florida
  • Able to travel to vendor for pairing with dog

Exclusion Criteria:

  • Been hospitalized for mental health reasons in the prior 6 months
  • Not living at the same residence for 6 months.
  • Diagnoses: Psychoses, Delusions, dementia, active alcohol/substance dependence. Moderate to severe TBI. Any other diagnosis deemed by PI to limit ability to participate or give informed consent
  • At time of enrollment - Active suicidal ideation, homicide, cognitive disabilities that would preclude safety of animal and ability needed for participation in the study.
  • Children under age 10 living in the home
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01329341
D8094-I
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Stephanie McGovern, RN James A. Haley Veterans' Hospital, Tampa, FL
Department of Veterans Affairs
May 2015

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