[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07021352":3,"trial-entities:NCT07021352":108,"trial-summary:NCT07021352":113},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":15,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":41,"secondary_outcomes":46,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":72,"locations":75,"central_contacts":100,"overall_officials":105,"references":106,"see_also_links":107},"NCT07021352","TSNRP N25D272IR","Auricular Acupuncture on Emotional Distress in Service Members and Veterans With PTSD","Effects of Auricular Acupuncture on Emotional Distress in Service Members and Veterans With Posttraumatic Stress Disorder","RECRUITING","2028-06","2026-04","2026-04-24","2026-03-02","United States Naval Medical Center, San Diego","FED",null,"Emotional distress (ED) refers to a state of mental suffering that significantly impairs an individual's ability to cope, often leading to a decline in overall well-being. In military contexts, ED is a prevalent concern due to the unique and demanding challenges faced by military personnel both in combat zones and during peacetime. The primary objective of this study is to assess the efficacy of integrating ear acupuncture with mindfulness therapy in mitigating ED and alleviating post-traumatic stress disorder (PTSD) symptoms among military personnel. The study will examine the effects of auricular acupuncture (AA) and mindfulness therapy (MT) on ED in military personnel with PTSD. The NADA ear acupuncture protocol will be administered using acupuncture semi-permanent (ASP), sterile needles placed in the bilateral ears, which will remain in place until they naturally fall out. Mindfulness therapy will incorporate relaxation techniques, such as yoga and controlled breathing exercises, specifically designed to alleviate ED. A mixed-methods approach, integrating both quantitative and qualitative methods, will be employed concurrently to evaluate the interventions' effectiveness and to explore the participants' perceived benefits. Specific Aim 1: To evaluate the effectiveness and perceived benefits of the National Acupuncture Detoxification Association (NADA) ear acupuncture protocol as an adjunct therapy to brief mindfulness therapy for reducing emotional distress in service members and veterans with PTSD. Specific Aim 2: To examine the effectiveness of NADA as an adjunct therapy to brief mindfulness therapy in improving sleep disturbances, alcohol use, and pain in service members and veterans with PTSD.",[18,19],"PTSD and Substance Use Disorder","Emotional Distress",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},66,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Ear acupuncture","Ear Acupuncture: Participants will receive bilateral NADA ear acupuncture protocol treatment for a one-time insertion in addition to the weekly mindfulness therapy received by participants. The NADA consists of 5 ear acupuncture points inserted bilaterally: shen men, sympathetic, kidney, liver, and lung. Sterile, semi-permanent acupuncture needles (2mm) will be inserted into the participant's ear and left in place until they naturally fall out, typically within 3-7 days.",[34],"Ear acupuncture plus mindfulness therapy",{"type":36,"name":37,"description":38,"armGroupLabels":39},"BEHAVIORAL","Mindfulness therapy","Mindfulness: Participants will receive virtual mindfulness therapy weekly for 30 minutes each session via the MS Teams platform.",[34,40],"Mindfulness Therapy Only",[42],{"measure":43,"description":44,"timeFrame":45},"Patient-Reported Outcomes Measurement Information System Emotional Distress - Anger Short Form 8a","Minimum value= 5, Maximum value = 40; higher scores mean worse outcome","Baseline, post 2-week intervention, post 4-week intervention",[47,50,53,56],{"measure":48,"description":49,"timeFrame":45},"Posttraumatic Stress Disorder Checklist for Diagnostic Statistical Manual-5","Minimum value = 0, Maximum value = 80, higher scores mean worse outcome",{"measure":51,"description":52,"timeFrame":45},"Insomnia Severity Index","Minimum value= 0, Maximum value = 28; higher scores mean worse outcome",{"measure":54,"description":55,"timeFrame":45},"Alcohol Use Disorders Identification Test","Minimum value= 0, Maximum value = 40; higher scores mean worse outcome",{"measure":57,"description":58,"timeFrame":45},"Numeric Rating Scale","Minimum value= 0, Maximum value = 10; higher scores mean worse outcome","ALL","18 Years","65 Years",false,{"inclusion":64,"exclusion":70,"raw_text":71},[65,66,67,68,69],"Active duty service member and veterans","A score of 14 or above on the abbreviated PCL 6-item","A score of 24 or above on the EDS","Agrees to participate in mindfulness therapy","Able to provide informed consent",[],"Inclusion Criteria:\n\n* Active duty service member and veterans\n* A score of 14 or above on the abbreviated PCL 6-item\n* A score of 24 or above on the EDS\n* Agrees to participate in mindfulness therapy\n* Able to provide informed consent\n\nExclusion Criteria:\n\n\\- Has had mindfulness therapy received from a healthcare provider in the past month",[73,74],"ADULT","OLDER_ADULT",[76,91],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":88},"David Grant USAF Medical Center","Fairfield","California","94533","United States",[83],{"name":84,"role":85,"phone":86,"email":87},"Jocelyn Caballero","CONTACT","628-399-0925","jocelyn.caballero@ucsf.edu",{"lat":89,"lon":90},38.24936,-122.03997,{"facility":92,"status":8,"city":93,"state":79,"zip":94,"country":81,"contacts":95,"geoPoint":97},"Naval Medical Center San Diego","San Diego","92134",[96],{"name":84,"role":85,"phone":86,"email":87},{"lat":98,"lon":99},32.71571,-117.16472,[101],{"name":102,"role":85,"phone":103,"email":104},"Jane Abanes","808-421-9562","jjabanes@gmail.com",[],[],[],{"nct_id":4,"conditions":109,"biomarkers":112},[19,110,111],"Post-Traumatic Stress Disorder","Substance use disorder",[],{"nct_id":4,"found":114,"summary":115,"prompt_version":125},true,{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This study plans to enroll 66 participants to assess the effects of ear acupuncture and mindfulness therapy. It is an interventional study, but details like randomization or blinding are not specified.","completed","Auricular Acupuncture and Mindfulness for Emotional Distress and PTSD","This study is looking at how ear acupuncture and mindfulness therapy can help service members and veterans who are experiencing emotional distress and post-traumatic stress disorder (PTSD). Participants will receive a one-time ear acupuncture treatment (NADA protocol) and weekly 30-minute virtual mindfulness therapy sessions. Researchers will measure changes in emotional distress, specifically anger, at the start of the study, after two weeks, and after four weeks. To join, you must be an active duty service member or veteran between 18 and 65 years old, have certain scores on PTSD and emotional distress questionnaires, and agree to participate in mindfulness therapy. The study aims to enroll 66 participants, but its current status is unclear.","Your emotional distress will be measured at baseline, after two weeks, and after four weeks.",113,"You would receive a one-time ear acupuncture treatment and participate in weekly 30-minute virtual mindfulness therapy sessions. Your emotional distress levels will be measured at the start, after two weeks, and after four weeks.","Not stated in the trial record.",[31,37],"v2"]