Pilot Study Adapting EAT-PTSD for Anxious Youth

NCT05298397 | Terminated

• 1 other identifier: 8260
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research protocol is to adapt the Equine Assisted Therapy (EAT) protocol, which the investigators had developed to help treat PTSD (EAT-PTSD; the Man O' War (MOW) protocol), for use with adolescents who have an anxiety disorder. The MOW protocol is an eight session, group therapy EAT protocol, which the investigators developed, piloted, revised, and tested. EAT is an alternative treatment practiced across the United States and around the world for mental health disorders, in which the horse(s) play an essential role in an experientially oriented therapeutic approach. The MOW protocol is for group EAT, with groups led by a licensed mental health provider and an "equine specialist," working with two horses and assisted by a wrangler (horse handler) to assure safety. In the open trial, the MOW protocol showed promising results in reducing the level of PTSD and Depressive symptoms in veterans with moderate to severe PTSD, was found to be safe (no adverse events), and well accepted (very few dropouts (Fisher et al., 2021)) and found evidence of neural changes (Zhu et al, 2021). As part of the MOW project, the investigators prepared a well specified treatment manual (Fisher et al, 2021) - the first of its kind in the field of EAT - and have trained others in its use.

Conditions

Anxiety Disorder of Childhood or Adolescence

Outcome Measures

Primary Outcomes (5)

• Pediatric Anxiety Rating Scale - Global Ratings (PARS)

  A clinician-rated measure of symptom severity and associated impairment that targets generalized anxiety disorder, social phobia, and separation anxiety disorder

  5 minutes

• Children's Global Assessment Scale (CGAS)

  A clinician rating of a child's social and psychological functioning

  2 minutes

• Screen for Child Anxiety Related Disorders (SCARED) - Youth

  A child self-report instrument used to screen for childhood anxiety disorders including general anxiety disorder, separation anxiety disorder, panic disorder and social phobia

  4 minutes

• Screen for Child Anxiety Related Disorders (SCARED) - Parent

  A parent/other administered scale that aids in the diagnosis of panic disorder/significant somatic symptoms, generalized anxiety disorder, separation anxiety disorder, social anxiety disorder, and significant school avoidance

  4 minutes

• Clinical Global Impressions - Improvement Scale (CGI-I)

  A scale that rates the degree of clinical improvement at the time of assessment, relative to how the patient was at entry (Score from 1-7)

  2 minutes

Secondary Outcomes (7)

• Anxiety Disorders Interview Schedule - Child and Parent (ADIS-C)

  160 minutes

• Columbia Impairment Scale - Parent Form

  2 minutes

• Mood and Feelings Questionnaire - Parent Long Form

  5 minutes

• Mood and Feelings Questionnaire - Youth Long Form

  5 minutes

• Patient-Reported Outcomes Measurement Information System (PROMIS): Short Form 8A - Family Relationships (Parent)

  2 minutes

Study Arms (1)

Intervention - EAT

EXPERIMENTAL

This study has one arm (it is an open trial). All participants will receive the intervention (EAT-PTSD adapted for youth).

Other: EAT-PTSD adapted for youth for anxiety

Interventions

EAT-PTSD adapted for youth for anxiety OTHER

This is an eight session (90 minute sessions) weekly experiential group treatment. The first session includes psychoeducation, orientation to treatment, a barn tour, and ends with meeting the horses. Subsequent sessions involve increasingly complex encounters and interactions with horses accompanied by feedback and direction from the treatment. Early phase treatment exercises acquaint patients with the horse, with grooming exercises, leading with a rope or a wand, and directing the horse. The middle phase furthers patients' mastery and comfort with the horse in individual and teamwork exercises. The final session includes a graduation ceremony. All intervention sessions begin with "Opening Circle" and end with "Closing Circle." Opening Circle incorporates a "grounding exercise" and is orients participants to the session to check in regarding thoughts and feelings. Closing Circle reviews lessons learned during the session, eliciting participant feedback and facilitating discussion.

Intervention - EAT

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Youth ages 13-17
• Youth lives with parent
• English speaking (youth and parent) who reside in Westchester, Putnam, Rockland, Bronx, or Manhattan Counties (in New York) OR in Connecticut
• Youth does not have a current substance use problem
• Youth is available for an "after school" group at time the EAT sessions are scheduled
• Parent understands that participation does not affect place on clinic waiting list
• Parent will be able to provide/assure transportation to equestrian center, etc.
• Current diagnosis of Social Anxiety Disorder, Separation Anxiety Disorder, Generalized Anxiety Disorder, or Unspecified Anxiety Disorder
• Parent understands the protocol, agrees to their responsibilities (providing transport, scheduling sessions), and is able to give consent
• Youth understands the protocol and consents (if age 18) or assents (if younger than age 18) of their own free will

You may not qualify if:

• Elevated depression, PTSD, or OCD symptoms of clinical concern
• Elevated risk for suicide/suicidal behavior based on history and current mental state
• Extreme fear of horses
• Orthopedic or other physical limitation that would prevent youth from walking unassessed and/or walking freely in ring
• Acute, unstable, or severe medical disorder (that might prohibit completing the 8 session protocol)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Columbia University: collaborator

Study Sites (2)

1051 Riverside Drive

New York, New York, 10032, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related Publications (3)

• Zhu X, Suarez-Jimenez B, Zilcha-Mano S, Lazarov A, Arnon S, Lowell AL, Bergman M, Ryba M, Hamilton AJ, Hamilton JF, Turner JB, Markowitz JC, Fisher PW, Neria Y. Neural changes following equine-assisted therapy for posttraumatic stress disorder: A longitudinal multimodal imaging study. Hum Brain Mapp. 2021 Apr 15;42(6):1930-1939. doi: 10.1002/hbm.25360. Epub 2021 Feb 5.

  PMID: 33547694 BACKGROUND

• Fisher PW, Lazarov A, Lowell A, Arnon S, Turner JB, Bergman M, Ryba M, Such S, Marohasy C, Zhu X, Suarez-Jimenez B, Markowitz JC, Neria Y. Equine-Assisted Therapy for Posttraumatic Stress Disorder Among Military Veterans: An Open Trial. J Clin Psychiatry. 2021 Aug 31;82(5):21m14005. doi: 10.4088/JCP.21m14005.

  PMID: 34464523 BACKGROUND

• Arnon S, Fisher PW, Pickover A, Lowell A, Turner JB, Hilburn A, Jacob-McVey J, Malajian BE, Farber DG, Hamilton JF, Hamilton A, Markowitz JC, Neria Y. Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. Mil Med. 2020 Jun 8;185(5-6):e557-e564. doi: 10.1093/milmed/usz444.

  PMID: 32034416 BACKGROUND

Study Officials

• Prudence Fisher, PhD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 28, 2022
• Study Start: April 29, 2022
• Primary Completion: November 23, 2022
• Study Completion: November 23, 2022
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)