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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300255
• Other study ID #: IRB 00166616
• Status: Recruiting
• Start date: April 24, 2024
• Est. completion date: February 1, 2029

Study information

• Verified date: May 2024
• Source: VA Salt Lake City Health Care System
• Contact: William Marchand, MD
• Phone: 801-582-1565
• Email: william.marchand[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: February 1, 2029
• Est. primary completion date: February 1, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• PTSD

Intervention

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/.

Locations

Country	Name	City	State
United States	George E. Wahlen Department of Veterans Affairs Medical Center	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
VA Salt Lake City Health Care System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	through study completion, an average of 5 years
Secondary	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.	through study completion, an average of 5 years
Secondary	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.	through study completion, an average of 5 years