Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04159506 |
Other study ID # |
D3312-P |
Secondary ID |
02342-003 |
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 20, 2022 |
Est. completion date |
July 30, 2023 |
Study information
Verified date |
October 2023 |
Source |
VA Office of Research and Development |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The VA Office of Patient Centered Care and Cultural Transformation's Whole Health initiative
promotes the use of complementary and integrative health (CIH) approaches with traditional
medical care to help Veterans achieve meaningful life goals and improved functioning.
Equine-facilitated therapy (EFT), an animal-assisted form of CIH, is increasingly available
to Veterans within the VA. Horses have extreme sensitivity to the emotional states,
behaviors, and intentions of their herds and other animals, including humans, and mirror body
language and respond to subtle nonverbal cues. As such, horses have the capacity to provide
immediate feedback about a people's emotional and behavioral states. This capacity affords
people opportunities to become more emotionally self-aware and, with guidance from EFT
facilitators, learn how to regulate emotions and become calmer and more patient, attentive,
and confident to gain the horses' cooperation. Participants in EFT are encouraged to apply
what they have learned from their equine experiences to their relationships with people.
Since high quality social functioning depends on effective regulation of one's emotions, EFT
offers a novel way in which to improve the social functioning of Veterans with mental health
concerns. VAs are increasingly embracing EFT as a CIH. However, carefully conducted,
scientifically valid research about EFT has not been conducted. Existing peer-reviewed
research about EFT for mental health is very limited, of poor methodological quality, and not
focused on adults. None of it targets social functioning as a main outcome. This small
randomized controlled pilot study proposes to examine an innovative EFT called The Equus
Effect (TEE) as a complement to Veterans' existing VA mental health services to improve
social functioning. TEE aims to improve Veterans' social functioning by developing their
emotion regulation and interpersonal skills through therapeutic interactions with horses.
This study will evaluate 1) the feasibility of study procedures, assessments, and outcomes,
2) the fidelity of experimental and control interventions, and 3) the acceptability of the
interventions to Veterans and their mental health clinicians using mixed
quantitative-qualitative methods. The study has the potential to lend initial credibility to
the therapeutic claims of this increasingly popular CIH.
Description:
**Please note that as a consequence of the COVID-19 pandemic, and after consultation with the
appropriate research oversight, regulatory and monitoring entities, screening and enrollment
was placed on temporary administrative hold from 04/30/2020 - 3/31/2022. Experimental and
comparator conditions had to occur in person, in groups, and with van transportation to and
from the intervention site. The study resumed preparations for the pilot trial 4/1/2022 and
began participant screening and recruitment 6/15/2022.**
The VA Office of Patient Centered Care and Cultural Transformation launched the Whole Health
initiative to transform the Veterans Health Administration into a healthcare system in which
providers and Veterans develop holistic, personalized, proactive, patient-driven healthcare
plans that center on realizing meaningful life goals and improved functioning. Whole Health
promotes the use of complementary and integrative health (CIH) approaches with traditional
medical care to achieve these aims - consistent with psychosocial rehabilitation's emphasis
on recovery-oriented, community-based functional outcomes. Equine-facilitated therapy (EFT),
an animal-assisted form of CIH, is increasingly available to Veterans within the VA. Horses
are prey animals with extreme sensitivity to the emotional states, behaviors, and intentions
of their herds and other animals, including humans, and mirror body language and respond to
subtle nonverbal cues. As such, horses have the capacity to provide immediate feedback about
a person's emotional and behavioral states (e.g., pinning ears back when someone is angry or
relaxing them forward when a person is calm). As a person interacts with horses, this
capacity affords him or her an opportunity to become more emotionally self-aware and, with
guidance from EFT facilitators, learn how to regulate emotions and become calmer and more
patient, attentive, and confident to gain the horses' cooperation. With EFT, emotion
regulation is the key mechanism for social interaction with horses, and participants in EFT
are encouraged to apply what they have learned from their equine experiences to their
relationships with people. Since high quality social functioning depends on effective
regulation of one's emotions, EFT offers a novel way in which to improve the social
functioning of Veterans with mental health concerns. In fact, in the VA, EFT has been used to
address a variety of diagnostic issues commonly experience by Veterans, including PTSD,
depression, anxiety, substance use and eating disorders. However, peer-reviewed published
quantitative and qualitative research on EFT as a CIH for mental health is very limited, of
poor methodological quality, and focused on school-age children and adolescents, not adults.
None of it targets social functioning as a main outcome. Given VAs increasing embrace of EFT
as a CIH, carefully conducted research that aims to systematically develop and study EFT for
Veterans is sorely needed to ensure that EFT is feasible to study, acceptable to Veterans and
clinicians, and clinically promising.
The investigators propose to pilot test an innovative EFT called The Equus Effect (TEE) as a
complement to Veterans' existing VA mental health services to improve social functioning. TEE
aims to improve Veterans' social functioning by developing their emotion regulation and
interpersonal skills through therapeutic interactions with horses. In line with
recommendations for pilot investigations, the investigators will conduct a randomized pilot
study to 1) evaluate the feasibility of study procedures, assessments, and outcomes, 2)
demonstrate experimental and control interventions can be delivered with fidelity, and 3)
examine the acceptability of the interventions. To accomplish these goals, the investigators
will enroll a transdiagnostic cohort of 40 Veterans involved in VA mental health services
with social dysfunction and emotion dysregulation. Participants will be randomized to receive
either 1) TEE or 2) attention control (AC), both group interventions. Each week, the
4-session TEE will include 1) mindfulness activities, 2) emotion regulation and interpersonal
skills education, 3) experiential activities with horses incorporating opportunities to
develop emotion regulation and interpersonal skills, and 4) between-session application of
lessons learned from the equine activities. AC will have similar elements without equine
features. Intervention outcomes will be measured at 4- and 16-weeks post randomization.
Specifically, using mixed quantitative-qualitative methods, the investigators aim to:
Aim 1: Determine the feasibility of recruitment, randomization, retention, assessment
procedures, and implementation of TEE and AC. Hypothesis: Rates of recruitment will be at
least 8 participants per month, and Veterans randomized to TEE will attend intervention
sessions, remain in the study, and experience clinically significant changes in social
functioning and emotion dysregulation at rates equal to or superior to AC.
Aim 2: Demonstrate TEE and AC can be delivered with fidelity. Hypothesis: Facilitators will
deliver each intervention consistently and as intended across sessions.
Aim 3: Establish acceptability of TEE and AC by assessing intervention credibility and
satisfaction and the usefulness of TEE as a complementary mental health intervention using
mixed quantitative-qualitative methods. Hypothesis: Veterans will find TEE and AC credible
and satisfying and Veterans and their mental health clinicians will qualitatively report the
therapeutic benefits of TEE as a CIH for mental health treatment.