Evaluation of the H.O.O.V.E.S. Healing Intensives Program

NCT06300255 | Recruiting

• 1 other identifier: IRB 00166616
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention.

Conditions

Anxiety; PTSD; Depression

Keywords

Horses; Anxiety; PTSD; Depression

Outcome Measures

Primary Outcomes (7)

• Mean Difference in AAQII pre- to post-session and pre- to post-intervention

  AAQII is a 10-item measure that assesses psychological flexibility, with higher values indicating greater psychological inflexibility. The aim is to assess for statistically significant changes pre- to post session (1 day = a session) and pre- to post-intervention using paired t-test as well as ANCOVA adjusting for the significant demographic or diagnostic covariates.

  through study completion, an average of 5 years

• Mean Difference in PANAS pre- to post-session and pre- to post-intervention

  PANAS measures short-term positive and negative emotions. The aim is to assess for statistically significant changes pre- to post session (1 day = a session) and pre- to post-intervention using paired t-test as well as ANCOVA adjusting for the significant demographic or diagnostic covariates.

  through study completion, an average of 5 years

• Mean Difference in STAI pre- to post-session and pre- to post-intervention

  The STAI tracks the symptoms of anxiety, and the total score ranges from 20 to 80. The aim is to assess for statistically significant changes pre- to post session (1 day = a session) and pre- to post-intervention using paired t-test as well as ANCOVA adjusting for the significant demographic or diagnostic covariates.

  through study completion, an average of 5 years

• Mean Difference in PCL pre- to post-session and pre- to post-intervention

  PCL measures PTSD symptoms. The total PCL score can range from 17 to 85, with higher values indicating greater PTSD symptoms. The aim is to assess for statistically significant changes pre- to post session (1 day = a session) and pre- to post-intervention using paired t-test as well as ANCOVA adjusting for the significant demographic or diagnostic covariates.

  through study completion, an average of 5 years

• Mean Difference in BDI pre- to post-session and pre- to post-intervention

  The Beck Depression Inventory (BDI) measures depressive symptoms, with higher values indicating greater depressive symptoms. The aim is to assess for statistically significant changes pre- to post session (1 day = a session) and pre- to post-intervention using paired t-test as well as ANCOVA adjusting for the significant demographic or diagnostic covariates.

  through study completion, an average of 5 years

• Mean Difference in PTGI pre- to post-session and pre- to post-intervention

  The Post-Traumatic Growth Inventory (PTGI) examines the post-trauma growth using 21 items. The aim is to assess for statistically significant changes pre- to post session (1 day = a session) and pre- to post-intervention using paired t-test as well as ANCOVA adjusting for the significant demographic or diagnostic covariates.

  through study completion, an average of 5 years

• Mean Difference in B-SCS pre- to post-session and pre- to post-intervention

  The Brief Suicide Cognitions Scale (B-SCS) assesses the suicide risk. The aim is to assess for statistically significant changes pre- to post session (1 day = a session) and pre- to post-intervention using paired t-test as well as ANCOVA adjusting for the significant demographic or diagnostic covariates.

  through study completion, an average of 5 years

Secondary Outcomes (3)

• Mean Difference in AAQII pre- to post-session

  through study completion, an average of 5 years

• Mean Difference in PANAS pre- to post-session

  through study completion, an average of 5 years

• Mean Difference in STAI pre- to post-session

  through study completion, an average of 5 years

Study Arms (1)

H.O.O.V.E.S. Healing Intensives Participants

Veterans enrolled in a H.O.O.V.E.S. healing intensives program and must have served in the military.

Behavioral: H.O.O.V.E.S. Healing Intensives

Interventions

H.O.O.V.E.S. Healing Intensives BEHAVIORAL

"H.O.O.V.E.S. is a private, donor-supported charity dedicated to providing fully-funded, \[4\]-day, non-clinical healing intensives for veterans, their families and caregivers, and first responders across the nation who are seeking recovery from service-connected stress." 1 References 1\. Home. HOOVES for Vets. Accessed January 24, 2024. https://www.hooves.us/.

H.O.O.V.E.S. Healing Intensives Participants

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans enrolled in a H.O.O.V.E.S. healing intensives program and must have served in the military.

You may qualify if:

• Veterans who have served in the military
• Must be enrolled in a H.O.O.V.E.S. Healing Intensives Program
• English speakers

Sponsors & Collaborators

• VA Salt Lake City Health Care System: lead

Study Sites (1)

George E. Wahlen Department of Veterans Affairs Medical Center

Salt Lake City, Utah, 84148, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Stress Disorders, Post-Traumatic; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Behavioral Symptoms; Behavior

Study Officials

• William Marchand, MD

  VA Salt Lake City HCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

William Marchand, MD

CONTACT

801-582-1565; william.marchand@va.gov

Elena Nazarenko, MStat

CONTACT

801-582-1565; elena.nazarenko@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 8, 2024
• Study Start: April 24, 2024
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)