[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06375083":3,"trial-entities:NCT06375083":113,"trial-summary:NCT06375083":116},{"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":17,"conditions":18,"keywords":21,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":42,"secondary_outcomes":59,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":82,"locations":85,"central_contacts":105,"overall_officials":108,"references":111,"see_also_links":112},"NCT06375083","23-1231","Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression","Implementing Computerized Cognitive Behavioral Therapies for Suicide Prevention and Depression Among At-Risk Rural and Urban Veterans","RECRUITING","2026-08-30","2026-02","2026-02-19","2024-03-20","VA Eastern Colorado Health Care System","FED",false,"This study plans to learn more about the use of one of two self-guided online cognitive behavioral therapy courses. One is focused on symptoms of depression and one is focused on history of suicidal thoughts and behaviors.","Based on previous work with other computerized CBT (cCBT) interventions (e.g., cCBT-D), which has found that cCBT has similar effectiveness to traditional CBT, members of the team along with Veterans Health Administration (VHA) leaders have developed computerized cCBT-SP and cCBT-D courses that will be ready for safety, feasibility, and acceptability testing. If proven to be feasible, safe, and effective, these courses could be made available to all Veterans, at no cost to users.",[19,20],"Suicide","Depression",[19,20,22,23],"Veterans","Cognitive Behavioral Therapy","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},472,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","c-CBT for Suicide Prevention","Online c-CBT for SP The computerized Cognitive Behavioral Therapy for Suicide Prevention (cCBT-SP) course is comprised of 12 online sessions and is augmented by use of a companion workbook.",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"c-CBT or Depression","The computerized Cognitive Behavioral Therapy for Depression (cCBT-D) course is comprised of 12 online sessions and is augmented by use of a companion workbook.",[41],"c-CBT for Depression",[43,47,49,51,53,56],{"measure":44,"description":45,"timeFrame":46},"Client Satisfaction Questionnaire","Acceptability","12 weeks",{"measure":48,"description":45,"timeFrame":46},"Internet Evaluation and Utility Questionnaire",{"measure":50,"description":45,"timeFrame":46},"Internet Impact and Effectiveness Questionnaire",{"measure":52,"description":45,"timeFrame":46},"Narrative Evaluation of Intervention Interview",{"measure":54,"description":55,"timeFrame":46},"Recruitment Rate","Number of individuals who consented to participate",{"measure":57,"description":58,"timeFrame":46},"Completion of intervention","Number of participants who completed most or all of the sessions",[60,63,66,69,72],{"measure":61,"description":62,"timeFrame":46},"Beck Scale for Suicide Ideation","Change in suicidal ideation",{"measure":64,"description":65,"timeFrame":46},"Patient Health Questionnaire-9","Change in depression symptoms",{"measure":67,"description":68,"timeFrame":46},"Posttraumatic Stress Disorder Checklist-5","Change in PTSD symptoms",{"measure":70,"description":71,"timeFrame":46},"Generalized Anxiety Disorder-7","Change in anxiety symptoms",{"measure":73,"description":62,"timeFrame":46},"Computerized Adaptive Testing - Suicide Scale","ALL","18 Years","65 Years",true,{"inclusion":79,"exclusion":80,"raw_text":81},[],[],"Cohort A - cCBT-SP Program\n\nInclusion Criteria:\n\n1. Veterans between the ages of 18 and 65\n2. Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA Care\n3. Recent suicidal ideation (past month; C-SSRS Screener -Yes to Item 2) and history of lifetime suicidal behavior (lifetime, C-SSRS Screener - Yes to Item 6)\n4. Reliable access to a computer\u002Ftablet and the internet\n5. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record\n2. Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record\n3. Severe cognitive impairment, as determined by screening or electronic medical record\n4. Currently enrolled in\u002Fparticipating in another mental health-related intervention research study\n\nCohort B - cCBT-D Program\n\nInclusion Criteria:\n\n1. Veterans between the ages of 18 and 65\n2. Currently living in Colorado, New York, Montana, Texas, or Utah who have accessed VA care\n3. Mild to moderate depressive symptoms, as determined by the PHQ-9, (score of 5-14)\n4. Reliable access to a computer\u002Ftablet and the internet\n5. Ability to provide informed consent\n\nExclusion Criteria:\n\n1. PHQ-9 score below 4 or 15 and above\n2. Active alcohol or substance use disorder, excluding Cannabis dependence, as determined by screening or electronic medical record\n3. Identification of active psychosis or bipolar disorder, as determined via screening or electronic medical record\n4. Severe cognitive impairment, as determined by screening or electronic medical record\n5. Currently enrolled in\u002Fparticipating in other intervention research study",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":102},"Eastern Colorado Health Care System","Aurora","Colorado","80045","United States",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Lisa A Brenner, PhD","CONTACT","720-723-6488","Lisa.Brenner@va.gov",{"name":99,"role":95,"phone":100,"email":101},"Kelly A Stearns-Yoder, MA","720-723-6477","Kelly.Stearns@va.gov",{"lat":103,"lon":104},39.72943,-104.83192,[106],{"name":99,"role":95,"phone":100,"email":107},"kelly.stearns@va.gov",[109],{"name":94,"affiliation":13,"role":110},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":114,"biomarkers":115},[20,19],[],{"nct_id":4,"found":77,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This study is an interventional study planning to enroll 472 participants. It is testing two different behavioral interventions.","completed","Online Cognitive Behavioral Therapies for Suicide Prevention and Depression","This study is exploring two online courses: c-CBT for Suicide Prevention (cCBT-SP) and c-CBT for Depression (cCBT-D). These courses use cognitive behavioral therapy, a type of talk therapy, to help with symptoms of depression and past suicidal thoughts or behaviors. The study aims to see if these online courses are safe, easy to use, and helpful. You might be able to join if you are a Veteran between 18 and 65 years old, live in Colorado, New York, Montana, Texas, or Utah, have accessed VA care, and have recently had suicidal thoughts and a history of suicidal behavior. The study will measure how satisfied participants are with the courses and how useful and effective they find them after 12 weeks. The current recruitment status is unclear.","Your satisfaction and the usefulness of the online courses will be measured at 12 weeks after starting the intervention.",126,"You would participate in 12 online sessions for either the cCBT-SP or cCBT-D course, along with using a companion workbook.","Not stated in the trial record.",[34],"v2"]