[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06300255":3,"trial-entities:NCT06300255":110,"trial-summary:NCT06300255":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":20,"study_type":22,"primary_purpose":14,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":57,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":78,"locations":81,"central_contacts":98,"overall_officials":104,"references":108,"see_also_links":109},"NCT06300255","IRB 00166616","Evaluation of the H.O.O.V.E.S. Healing Intensives Program","RECRUITING","2029-02-01","2024-05","2024-05-28","2024-04-24","VA Salt Lake City Health Care System","FED",null,"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.",[17,18,19],"Anxiety","PTSD","Depression",[21,17,18,19],"Horses","OBSERVATIONAL",[],{"count":25,"type":26},250,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"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\n\nReferences\n\n1\\. Home. HOOVES for Vets. Accessed January 24, 2024. https:\u002F\u002Fwww.hooves.us\u002F.",[33],"H.O.O.V.E.S. Healing Intensives Participants",[35,39,42,45,48,51,54],{"measure":36,"description":37,"timeFrame":38},"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",{"measure":40,"description":41,"timeFrame":38},"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.",{"measure":43,"description":44,"timeFrame":38},"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.",{"measure":46,"description":47,"timeFrame":38},"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.",{"measure":49,"description":50,"timeFrame":38},"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.",{"measure":52,"description":53,"timeFrame":38},"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.",{"measure":55,"description":56,"timeFrame":38},"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.",[58,61,64],{"measure":59,"description":60,"timeFrame":38},"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.",{"measure":62,"description":63,"timeFrame":38},"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.",{"measure":65,"description":66,"timeFrame":38},"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.","ALL","18 Years","120 Years",true,{"inclusion":72,"exclusion":76,"raw_text":77},[73,74,75],"Veterans who have served in the military","Must be enrolled in a H.O.O.V.E.S. Healing Intensives Program","English speakers",[],"Inclusion Criteria:\n\n* Veterans who have served in the military\n* Must be enrolled in a H.O.O.V.E.S. Healing Intensives Program\n* English speakers",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":7,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":95},"George E. Wahlen Department of Veterans Affairs Medical Center","Salt Lake City","Utah","84148","United States",[89],{"name":90,"role":91,"phone":92,"phoneExt":93,"email":94},"William Marchand, MD","CONTACT","801-582-1565","1847","william.marchand@va.gov",{"lat":96,"lon":97},40.76078,-111.89105,[99,100],{"name":90,"role":91,"phone":92,"phoneExt":93,"email":94},{"name":101,"role":91,"phone":92,"phoneExt":102,"email":103},"Elena Nazarenko, MStat","3891","elena.nazarenko@va.gov",[105],{"name":90,"affiliation":106,"role":107},"VA Salt Lake City HCS","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":111,"biomarkers":113},[17,19,112],"Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":70,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an observational study with a planned enrollment of 250 participants. It is not specified if it is randomized or blinded.","completed","H.O.O.V.E.S. Healing Intensives for Anxiety, PTSD, and Depression","This study is evaluating the H.O.O.V.E.S. Healing Intensives program, a 4-day program for veterans, their families, and first responders dealing with stress. Researchers want to see how much this program helps with anxiety, PTSD (Post-Traumatic Stress Disorder), and depression. They will use questionnaires to measure changes in your well-being before, during, and after the program, and then again at 90, 120, and 360 days later. To join, you must be a veteran who has served in the military, be enrolled in a H.O.O.V.E.S. program, and speak English. The study aims to see if there are significant improvements in your mental health after participating.","You will be followed for an average of 5 years, with specific assessments at 90, 120, and 360 days after the program.",103,"You would complete demographic questionnaires and psychological tests before, during, and after the H.O.O.V.E.S. program, and then again at 90, 120, and 360 days post-intervention.","Not stated in the trial record.",[30],"v2"]