AnxietyNCT06300255
Evaluation of the H.O.O.V.E.S. Healing Intensives Program
An observational study of Anxiety and PTSD, run by VA Salt Lake City Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, PTSD, Depression
- What is being tested?
- H.O.O.V.E.S. Healing Intensives
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 1 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans enrolled in a H.O.O.V.E.S. healing intensives program and must have served in the military.
Who may be able to join
- Veterans who have served in the military
- Must be enrolled in a H.O.O.V.E.S. Healing Intensives Program
- English speakers
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
George E. Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah, 84148
William Marchand, MD, 801-582-1565 ext. 1847, william.marchand@va.gov
About this study
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
- Being tested
- H.O.O.V.E.S. Healing Intensives
- Keywords
- Horses, Anxiety, PTSD, Depression
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H.O.O.V.E.S. Healing IntensivesBehavioural
"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
- Home. HOOVES for Vets. Accessed January 24, 2024. https://www.hooves.us/.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: H.O.O.V.E.S. Healing Intensives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 5 years
Secondary outcomes (3)
Mean Difference in AAQII pre- to post-session
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.
Measured: through study completion, an average of 5 years
Mean Difference in PANAS pre- to post-session
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.
Measured: through study completion, an average of 5 years
Mean Difference in STAI pre- to post-session
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.
Measured: through study completion, an average of 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start24 Apr 2024
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Salt Lake City Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- William Marchand, MD, Principal investigator, VA Salt Lake City HCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300255
- Sponsor's protocol ID
- IRB 00166616
- Status last verified
- May 2024
- First submitted
- 27 Feb 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the H.O.O.V.E.S. Healing Intensives Program
- ClinicalTrials.gov ID
- NCT06300255
- Acronym / sponsor ID
- IRB 00166616
- Conditions
- Anxiety, PTSD, Depression
- Keywords
- Horses, Anxiety, PTSD, Depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- VA Salt Lake City Health Care SystemUS federal agency
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| H.O.O.V.E.S. Healing Intensives Participants | – | Behavioral: H.O.O.V.E.S. Healing IntensivesVeterans enrolled in a H.O.O.V.E.S. healing intensives program and must have served in the military. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans enrolled in a H.O.O.V.E.S. healing intensives program and must have served in the military.
Key inclusion criteria (3 listed)
- Veterans who have served in the military
- Must be enrolled in a H.O.O.V.E.S. Healing Intensives Program
- English speakers
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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/. | Behavioural | H.O.O.V.E.S. Healing Intensives Participants |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
3 secondary outcomes
Mean Difference in AAQII pre- to post-session
Time frame: 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
Mean Difference in STAI pre- to post-session
Time frame: through study completion, an average of 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
Related trials for Anxiety
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
William Marchand, MD principal investigator
VA Salt Lake City HCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anxiety and PTSD, run by VA Salt Lake City Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William Marchand, MD (801-582-1565 ext. 1847, william.marchand@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Difference in AAQII pre- to post-session and pre- to post-intervention (time frame: through study completion, an average of 5 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.