- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06300255
Evaluation of the H.O.O.V.E.S. Healing Intensives Program
March 5, 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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
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
- Name: William Marchand, MD
- Phone Number: 1847 801-582-1565
- Email: william.marchand@va.gov
Study Contact Backup
- Name: Elena Nazarenko, MStat
- Phone Number: 3891 801-582-1565
- Email: elena.nazarenko@va.gov
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84148
- George E. Wahlen Department of Veterans Affairs Medical Center
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
"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
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
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.
Investigators
- 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 (Estimated)
April 22, 2024
Primary Completion (Estimated)
February 1, 2029
Study Completion (Estimated)
February 1, 2029
Study Registration Dates
First Submitted
February 27, 2024
First Submitted That Met QC Criteria
March 5, 2024
First Posted (Actual)
March 8, 2024
Study Record Updates
Last Update Posted (Actual)
March 8, 2024
Last Update Submitted That Met QC Criteria
March 5, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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