[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05969080":3,"trial-entities:NCT05969080":106,"trial-summary:NCT05969080":110},{"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":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":53,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":72,"locations":75,"central_contacts":99,"overall_officials":102,"references":104,"see_also_links":105},"NCT05969080","D4803-W","Self-Injury Treatment and Recovery in Veterans","A Brief Intervention to Reduce Nonsuicidal Self-Injury and Improve Functioning in Veterans","RECRUITING","2027-03-31","2026-02","2026-02-19","2024-10-15","VA Office of Research and Development","FED",false,"Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans.","Nonsuicidal self-injury (NSSI) refers to the intentional destruction of one's own body tissue without suicidal intent and for purposes that are not socially sanctioned. While NSSI has been understudied among Veterans, the lifetime prevalence rate of NSSI in Veterans is approximately three times higher than the general population. Moreover, NSSI is associated with increased risk for violence, psychiatric distress, and marked impairment in psychosocial functioning. Even though NSSI is distinct from suicidal behaviors in several important ways, NSSI remains a strong predictor of a future suicide attempt. The primary goal of this project is to evaluate the treatment and acceptability of a brief intervention for NSSI that aims to reduce psychosocial impairment and NSSI behaviors in Veterans. This treatment, known as the Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychoso ial functioning. A core component of T-SIB is functional assessment that identifies the antecedents and consequences of NSSI. This project will enhance T-SIB by using ecological momentary assessment (EMA) to conduct NSSI functional assessment in-vivo. EMA reduces retrospective recall bias and can increase engagement with therapeutic goals.",[19],"Self-Injurious Behavior",[19,21],"Veterans","INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},40,"ESTIMATED",[30,37],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"BEHAVIORAL","Treatment for Self-Injurious Behaviors","Treatment for Self-Injurious Behaviors (T-SIB) incorporates evidence-based approaches to replace NSSI with behaviors that improve psychosocial functioning.",[35],"T-SIB",[35],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"OTHER","Treatment As Usual","Participants randomized to the TAU condition will be provided with referrals to both Durham VA and local community mental health resources and offered a consult for Durham VA mental health services.",[39],[43],"TAU",[45,49],{"measure":46,"description":47,"timeFrame":48},"Feasibility as measured by number of participants enrolled","All participants (N = 40) will need to be enrolled by the end of the second year of the study to consider the recruitment benchmark met.","2 years after study enrollment begins",{"measure":50,"description":51,"timeFrame":52},"Feasibility as measured rate of retention","Retention will be measured by the number of participants who complete at least six T-SIB treatment sessions. This benchmark will be considered meet if at least 2\u002F3 of the 20 participants randomized to T-SIB complete at least 6 treatment sessions.","End of treatment, about nine weeks after beginning the study",[54],{"measure":55,"description":56,"timeFrame":52},"Number of participants who report satisfaction with the T-SIB treatment","Participant satisfaction will be measured with the Client Satisfaction Questionnaire (CSQ-8). Total scores on the CSQ-8 range from 8 to 32, which higher scores indicating higher satisfaction. A cut score of 24 will be used such that if the CSQ-8 score exceeds 24, that patient is deemed to have been satisfied with the treatment.","ALL","18 Years",null,{"inclusion":61,"exclusion":67,"raw_text":71},[62,63,64,65,66],"18 years of age or older","Past service in the United States military","Nonsuicidal self-injury engagement on 2 occasions in past 30 days","Fluent in English","Able to provide voluntary informed consent",[68,69,70],"Lifetime history of psychosis, mania, or hypomania","Imminent risk for suicide\u002Fhomicide warranting immediate intervention","Unable\u002Funwilling to complete study procedures","Inclusion Criteria:\n\n* 18 years of age or older\n* Past service in the United States military\n* Nonsuicidal self-injury engagement on 2 occasions in past 30 days\n* Fluent in English\n* Able to provide voluntary informed consent\n\nExclusion Criteria:\n\n* Lifetime history of psychosis, mania, or hypomania\n* Imminent risk for suicide\u002Fhomicide warranting immediate intervention\n* Unable\u002Funwilling to complete study procedures",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":77,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":96},"Durham VA Medical Center, Durham, NC","Durham","North Carolina","27705-3875","United States",[83,89,94],{"name":84,"role":85,"phone":86,"phoneExt":87,"email":88},"Tate F Halverson, PhD","CONTACT","919-286-0411","175415","Tate.Halverson@va.gov",{"name":90,"role":85,"phone":91,"phoneExt":92,"email":93},"Angela C Kirby, MS","(919) 286-0411","7456","angela.kirby@va.gov",{"name":84,"role":95},"PRINCIPAL_INVESTIGATOR",{"lat":97,"lon":98},35.99403,-78.89862,[100,101],{"name":84,"role":85,"phone":91,"phoneExt":87,"email":88},{"name":90,"role":85,"phone":91,"phoneExt":92,"email":93},[103],{"name":84,"affiliation":77,"role":95},[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Self-injurious behavior",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study with 40 participants. You would be randomly assigned to either receive T-SIB or Treatment As Usual.","completed","Treatment for Self-Injurious Behaviors in Veterans","This study is looking at a treatment called T-SIB (Treatment for Self-Injurious Behaviors) for veterans who have engaged in nonsuicidal self-injury (NSSI). NSSI is when someone intentionally harms their body without intending to die. The study aims to see if T-SIB can help reduce NSSI and improve overall well-being. You might be able to join if you are a veteran, 18 or older, have engaged in NSSI at least twice in the past 30 days, and can speak English. The study will enroll 40 participants and will measure how many people join and stay in the study as a sign of its success. The current recruitment status is unclear.","The study measures how many participants stay in the study at the end of treatment, which is about nine weeks after starting.",109,"Treatment lasts about nine weeks. The study will measure how many people stay in the study at the end of treatment.","Not stated in the trial record.",[32],"v2"]