Can Service Dogs Improve Activity and Quality of Life in Veterans With PTSD?

Background: Service Dogs are trained to assist people with disabilities to accomplish tasks
which permit the individual to be more functional in their home and social environment. Often
the dogs are trained to help in the completion of activities of daily living and instrumental
activities of daily living. Service Dogs are efficacious for individuals with disabilities,
such as vision limitations, spinal cord injury and hearing problems. In addition, some mental
health outcomes have improved with the introduction of a Service Dog. A research study was
mandated in the Department of Defense Bill of 2010, to examine the efficacy of service dogs
for Veterans with Post Traumatic Stress Disorder (PTSD). Together with the Cooperative
Studies Program, the proponents have designed a research study to effectively meet the
demands of the Bill and to provide timely research into an evolving field.

Study Primary Objective: To examine how limitations on activity and quality of life in
Veterans with PTSD are impacted by the provision of a Service Dog versus an Emotional Support
Dog.

Study Design: A three-year prospective randomized study is proposed which has two randomized
arms. Arm one of the study will be Veterans (n=110) randomized to receiving a Service Dog,
which has been trained for specific tasks to assist with the Veteran's disability. Arm two
(n=110) of the study will be Veterans randomized to receive an Emotional Support Dog (a dog
which provide emotional comfort). All Veterans, after confirmation of eligibility will be
randomized to receive a Service Dog or Emotional Support Dog and will be observed a minimum
of three months. During this period, Veterans will be required to participate in a Dog Care
Course to ensure they are aware of the demands dogs place on humans. Once dogs become
available, Veterans will be paired with a Service Dog or Emotional Support Dog. Follow-up
will begin at one week post pairing to track any dog behavior issues, and will continue after
pairing for 18 months. Primary outcomes to be examined include limitations on activity (as
measured by the WHO- DAS 2.0), quality of life (measured by the VR-12). Secondary outcomes
include PTSD symptoms (measured by the PCL), Suicidal ideation (Columbia-Suicide Severity
Rating Scale); depression (PHQ-9) and Sleep (Pittsburgh Sleep Quality Index). In addition,
health care utilization, anger management, employment and productivity will also be examined.
This multi-site study will be conducted at three locations, Nationwide.

Inclusion Criteria:

- Males and Females greater than> 18 years of age

- Referral from Mental Health provider that documents PTSD.

- PTSD as a result of any trauma as determined by meeting DSM 5 diagnostic criteria.

- Enrolled in mental health services at VA and has attended at least one visit in the 90
days prior to consent.

- If individual not currently enrolled in mental health treatment decides to enroll in
such then he/she may become eligible to participate in the study.

- If individual enrolled in mental health treatment schedules and attends a mental
health visit then he/she may become eligible to participate in the study.

- Agrees to remain in mental health treatment throughout the duration of the study

- Can adequately care for a dog

- Home environment is suitable for a dog.

- If the home environment can be remedied the potential participant may become eligible
to participate in the study

- If a participant moves home while enrolled in the study the new home must be suitable
for a dog

- Home environment is accessible for study staff

- If a participant moves home while enrolled in the study, the new home must be
geographically accessible to study staff.

- Is willing to accept randomization outcome..

- Has someone to care for dog in a long-term absence

- If no one is available to care for the dog but the situation changes then the
participant may become eligible to participate.

- Others in home are agreeable to having dog

- If others in the home are not agreeable but at a later date the situation changes,
then the potential participant may become eligible to participate

- Is willing and able to travel (by air or car) to training site for pairing

- If potential participant's unwillingness to travel to a training site changes, he/she
may become eligible to participate.

- Individual has no household pets that would threaten the dog-human bonding process

- If an individual has household pets but the situation changes, the individual may
become eligible to participate

- If a household dog lives inside the home and the home is partitioned such that there
are two or more separate living spaces served by independent entrance/exits, and the
individual does not live in a partition with a dog, then the individual can be
eligible. If a household dog lives primarily outside the home in a rural area and the
individual is not primarily responsible for feeding the dog on a daily basis, the
individual can be eligible.

- If an individual has pets other than dogs that could interfere with bonding, the
individual will be scheduled for screening visits and the relationship will be
assessed by the dog trainer.

- If an individual has a household dog or other pet that prevents participation in the
study but the situation changes, the individual may become eligible to participate. In
this instance, it will be the individual's responsibility to re-contact the study
team.

- If can verbalize understanding of consent form, is willing to provide written informed
consent and to follow study procedures.

Exclusion Criteria:

- Hospitalization for mental health reasons in the past 6 months

- Once six months since hospitalization have passed, the individual may become eligible
to participate in the study

- Aggressive behavior that would make it unsafe for dog

- Diagnosis of psychosis, delusions, dementia, active alcohol/substance dependence, or
moderate to severe traumatic brain injury

- Active suicidal intent as determined by a CPRS flag for suicidal intent or a score 5
on the C-SSRS completed at the baseline visit

- Homicidal intent or cognitive disabilities that would preclude safety of dog and/or
ability to participate in the study

- Social, mental or physical condition that prevents the potential participant from
either giving informed consent or participating in the study

- Participation in another research trial

- If a participant is in another unrelated study and both the study Chair/PI of this and
the other study consider participation in both studies to be acceptable then the
individual may become eligible to participate in the study.

- Has chart note flag for violent/disruptive behavior

- Potential participants who are pregnant/who have a partner who is pregnant, or who
currently have one or more children younger than the age of 5 in the household for
more than 8 hours per , one day a week will be excluded from the study.

- If a participant or anyone else in the household becomes pregnant during the
observation period, the participant will be excluded from the study.

- Participants who have children in their home/become pregnant after being paired with a
dog will be evaluated on a case by case basis.

- After a total of 10 dogs have been placed with participants who have children between
the ages of 5 and 10 years, and after each pairing has successfully reached and passed
the 2 month home visit, this exclusion criterion will be revisited for potential
inclusion of participants with children younger than 5 years.