Alliance180 Program for Trauma
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of North Carolina, Chapel Hill
Disqualifiers: Completed Alliance180 Program
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers.
The study aims are:
* Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers;
* Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention.
Participants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the Alliance180 Program for Trauma treatment?
Research suggests that equine-assisted therapy, a component of the Alliance180 Program, can help improve the functioning of individuals with various health conditions, including trauma. Studies have shown that equine-assisted interventions may benefit traumatized youth and older adults by enhancing their well-being and psychosocial functioning.
12345How is the Alliance180 Program for Trauma different from other treatments for trauma?
The Alliance180 Program is unique because it uses equine-assisted therapy, which involves interactions with horses to help improve emotional and social functioning. This approach is different from traditional talk therapies and is designed to address trauma by fostering trust, communication, and personal confidence through activities with horses.
46789Eligibility Criteria
This trial is for US Veterans, First Responders, and Front Line Healthcare Workers who have experienced trauma or stress. Participants must be adults willing to report on their well-being and mental health before and after the Alliance180 Program at various intervals.Inclusion Criteria
I am 18 years old or older.
Enrollment in an upcoming Alliance180 Program (limited to adults who currently or formerly serve as US Veterans, First Responders, and/or Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)
Exclusion Criteria
Individuals who have previously completed the Alliance180 Program
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Research Session
Participants complete self-report measures of demographic information, perception of safety, trauma experience, autonomic reactivity, anxiety/depression, and purpose in life
1 day
1 visit (virtual)
Alliance180 Program
Participants attend the 3-day Alliance180 Program, including the Transformative Equine Experience
3 days
Post-intervention Research Sessions
Participants complete self-report measures of perception of safety, trauma experience, autonomic reactivity, anxiety/depression, and purpose in life at 1 week, 1 month, 3 months, and 6 months after the program
6 months
4 visits (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The Alliance180 Program's impact on physical and psychological well-being is being tested. The study will assess changes in feelings of safety, autonomic functioning, depression, anxiety, and trauma response over time after completing the program.
1Treatment groups
Experimental Treatment
Group I: Alliance180 ProgramExperimental Treatment1 Intervention
Participants will attend the 3-day Alliance180 Program.
Alliance180 Program is already approved in United States for the following indications:
🇺🇸 Approved in United States as Alliance180 Program for:
- Post-traumatic stress disorder (PTSD) prevention
- Suicide prevention
- Trauma response management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Alliance180Saratoga Springs, NY
University of North Carolina at Chapel HillChapel Hill, NC
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Who Is Running the Clinical Trial?
University of North Carolina, Chapel HillLead Sponsor
ALLIANCE180, INCCollaborator
References
A replication study of a psychotherapy incorporating horses resiliency intervention for healthcare workers. [2023]The first aim of this pilot observational study was to replicate a previous study of a resiliency psychotherapy incorporating horses (PIH) intervention for healthcare workers. The second aim was to address some gaps in the literature regarding equine-assisted services more broadly.
Effects of equine-assisted therapy on the functionality of individuals with disabilities: systematic review and meta-analysis. [2022]Evaluate the effects of Equine-Assisted Therapy (EAT) on the functioning of individuals with different health conditions through a systematic review and meta-analysis of randomized clinical trials (RCT).
Development of an ICF-based assessment tool for equine-assisted therapy: model structure and reliability. [2023]Scientific investigation and documentation of equine-assisted therapy has increased over the past several years. Yet there are no standardized and validated tools for evidence-based measurement of processes and outcomes to assess equine-assisted interventions.
Equine Facilitated Therapy for Complex Trauma (EFT-CT). [2023]Emerging research suggests that Equine Facilitated Psychotherapy (EFP) may be beneficial for traumatized youth. In addition, complex trauma (i.e., multiple and/or prolonged developmentally adverse traumatic events which are typically interpersonal in nature) treatment research is still growing and there is a need for the development and examination of novel treatments for youth with complex trauma histories. The current article describes a promising EFP model for this population called Equine Facilitated Therapy for Complex Trauma (EFT-CT). EFT-CT embeds EFP practices within Attachment, Regulation and Competency (ARC), an extant evidence-based complex trauma treatment framework for children and adolescents. The authors provide three case studies using both observational data provided by clinicians, as well as longitudinal measures of psychosocial functioning, to illustrate the potential promise of EFT-CT. The article concludes with a discussion about implications for EFP treatment and research.
Effects of equine-assisted interventions on older adults' health: A systematic review. [2022]Equine-assisted interventions (EAI) can improve a variety of health problems in older adults and thus promote their well-being. This systematic review aimed to synthesize studies on EAI to understand better their effects on the health of older adults.
Equine-Assisted Therapy for Posttraumatic Stress Disorder Among Military Veterans: An Open Trial. [2021]Objective: As veterans have high rates of posttraumatic stress disorder (PTSD) and historically poor treatment outcomes and high attrition, alternative treatments have gained much popularity despite lack of rigorous research. In this study, a recently developed and manualized 8-session group Equine-Assisted Therapy for PTSD (EAT-PTSD) was tested in an open trial to assess its preliminary feasibility, acceptability, and outcomes for military veterans.
Equine-assisted psychotherapy: a mental health promotion/intervention modality for children who have experienced intra-family violence. [2007]Equine-assisted psychotherapy (EAP) is a specialized form of psychotherapy using the horse as a therapeutic tool. This modality is designed to address self-esteem and personal confidence, communication and interpersonal effectiveness, trust, boundaries and limit-setting, and group cohesion. Substantial numbers of children witness family violence. There is evidence that violence between parents has adverse effects on the children in the family. These children are at greater risk of behavioural problems and mental health disorders, including anxiety, anger, depression and suicidal ideations, withdrawal, low self-esteem, and attention deficit hyperactivity disorder. The purpose of the present pilot study was to test the efficacy of EAP in a cross-sectional group of children referred to a psychotherapist for various childhood behavioural and mental health issues over an 18-month period (June 2003-January 2005). Sixty-three children received a mean number of 19 EAP sessions. Scores on the Children's Global Assessment of Functioning (GAF) Scale were determined pre- and post-treatment. The mean (+/- standard deviation, SD) pretreatment score was 54.1 (SD 3.2) and post treatment mean score was 61.7 +/- 5.0 (t = 9.06, d.f. = 96, P
Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder. [2020]Posttraumatic stress disorder (PTSD) is a common and debilitating disorder among war veterans. Although complementary and alternative therapies are gaining acceptance in the treatment of PTSD, the efficacy of animal-based therapies in this disorder is unknown. The goal of equine-assisted psychotherapy (EAP) is to improve the social, emotional, and/or cognitive functions of individuals with PTSD.
Equine-Assisted Therapy for Veterans with PTSD: Manual Development and Preliminary Findings. [2021]Equine-assisted therapy (EAT) for post-traumatic stress disorder (PTSD) has attracted great interest despite lacking empirical support, a manual, and a standardized protocol. Our team of experts in EAT and PTSD developed an eight-session group EAT treatment protocol for PTSD (EAT-PTSD) and administered it to two pilot groups of military veterans to assess initial effects.