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

May 24, 2024 updated by: VA Salt Lake City Health Care System
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • Recruiting
        • George E. Wahlen Department of Veterans Affairs Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

"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/.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Difference in AAQII pre- to post-session and pre- to post-intervention
Time Frame: through study completion, an average of 5 years
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
Time Frame: through study completion, an average of 5 years
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
Time Frame: through study completion, an average of 5 years
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
Time Frame: through study completion, an average of 5 years
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
Time Frame: through study completion, an average of 5 years
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
Time Frame: through study completion, an average of 5 years
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
Time Frame: through study completion, an average of 5 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Difference in AAQII pre- to post-session
Time Frame: through study completion, an average of 5 years
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 between post sessions using the repeated measure ANOVA.
through study completion, an average of 5 years
Mean Difference in PANAS pre- to post-session
Time Frame: through study completion, an average of 5 years
PANAS measures short-term positive and negative emotions. The aim is to assess for statistically significant changes between post sessions using the repeated measure ANOVA.
through study completion, an average of 5 years
Mean Difference in STAI pre- to post-session
Time Frame: through study completion, an average of 5 years
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 between post sessions using the repeated measure ANOVA.
through study completion, an average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Salt Lake City Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Marchand, MD, VA Salt Lake City HCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB 00166616

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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