Feasibility and Acceptability Off The Equus Effect

NCT04159506 | Completed Results DMC

• 2 other identifiers: D3312-P02342-003
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Skills; Emotional Dysfunction

Keywords

equine therapy; social functioning; emotion regulation

Outcome Measures

Primary Outcomes (2)

• Social Adjustment Scale-Self Report (SAS-SR)

  SAS-SR details social functioning in a range of role areas (e.g., work, social and leisure, family); the overall SAS-SR score is 1 (no impairment), to 5 (highest impairment).

  Baseline, 4-weeks post-randomization, 16-weeks post-randomization

• Inventory of Interpersonal Problems-32 (IIP-32)

  IIP-32 taps people's interpersonal difficulties across role areas; the IIP-32 total score is 0 (no difficulties), to 4 (extreme difficulties).

  Baseline, 4-weeks post-randomization, 16-weeks post-randomization

Secondary Outcomes (1)

• Difficulties in Emotion Regulation Scale (DERS)

  Baseline, 4-weeks post-randomization, 16-weeks post-randomization

Study Arms (2)

The Equus Effect (TEE)

EXPERIMENTAL

TEE is a 4-session intervention. Each session is 4 hours and includes: 1) mindfulness-based activities; 2) didactics about emotion regulation and interpersonal skills; and 3) experiential learning activities with horses that provide opportunities to practice emotion regulation and interpersonal skills. At the end of each session, Veterans debrief about what they learned and identify how they might apply this knowledge to manage their mental health concerns and function better socially.

Behavioral: mindfulness, emotion didactics, interpersonal skills, experiential learning

Attention Control (AC)

ACTIVE COMPARATOR

AC will exclude equine-related activities or discussions but maintain mindfulness-based activities, emotion regulation and interpersonal skills didactics, and experiential learning activities with between-session application. Instead of experiential equine activities, AC will rely on team-building activities, which aim to enhance social relations by involving participants in collaborative tasks and providing opportunities for emotion regulation and interpersonal skills practice.

Behavioral: mindfulness, emotion didactics, interpersonal skills, experiential learning

Interventions

mindfulness, emotion didactics, interpersonal skills, experiential learning BEHAVIORAL

mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.

Attention Control (AC); The Equus Effect (TEE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• seeing a VA Connecticut mental health clinician at least 3 times in the past 3 months with intent to remain in treatment during study enrollment;
• age 18 and over;
• social dysfunction (score \> 2.5 on the Social Adjustment Scale-Self Report (SAS-SR) and \> 1.5 on Inventory of Interpersonal Problems-32 (IIP-32);
• emotion dysregulation (score \> 95 on the Difficulties in Emotion Regulation Scale (DERS);
• sufficient mobility to participate in study procedures, as determined by PI;
• consent to all study procedures, including audio recording of TEE and AC sessions.

You may not qualify if:

• psychotic disorder per self-report and verified in medical record or as determined by the Mini-International Neuropsychiatric Interview (MINI);
• acute suicidality;
• inability to read English or communicate in spoken English;
• anticipated unavailability to the study during the next 20 weeks;
• participation in any equine-facilitated therapy in the past 24 weeks;
• unavailability of a landline or cellular telephone.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Connecticut Healthcare System: collaborator

Study Sites (1)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516-2770, United States

Location

MeSH Terms

Conditions

Social Skills; Social Adjustment; Emotional Regulation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Self-Control

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

The pilot study had a small sample size not powered to detect statistically significant differences in clinical outcomes. It also examined the feasibility and acceptability of one specific equine-facilitated therapy; other equine-facilitated therapy programs may differ from the one we studied. Finally, follow-up was 3-months post-intervention. The feasibility of studying longer follow-up periods was not examined.

Results Point of Contact

• Title: Steve Martino, Ph.D.
• Organization: VA Connecticut Healthcare System

Steve.Martino@va.gov

203-932-5718

Study Officials

• Steve Martino, PhD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research assistant who will collect study assessments will not know the randomization of participants to conditions. Randomization will be conducted by the study coordinator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be block randomized to receive either 1) The Equus Effect (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.

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 12, 2019
• Study Start: June 20, 2022
• Primary Completion: July 30, 2023
• Study Completion: July 30, 2023
• Last Updated: September 26, 2024
• Results First Posted: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After one year of study completion
• Access Criteria: Interested parties may email the PI to request data sharing.

Locations

US (1)