[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624308":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":69,"collaborators":71,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":43,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":52,"whyStopped":43,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Umeå University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Blended TF-CBT with Compassion (bTF-CBT-C)","EXPERIMENTAL","Participants assigned to this arm receive blended trauma-focused cognitive behavioral therapy with integrated compassion-focused strategies (bTF-CBT-C), delivered in a structured sequence combining therapist-led sessions and self-paced app-based modules. The intervention includes an initial clinic-based introduction with safety planning (C0), app-supported psychoeducation and compassion-based stabilization modules targeting emotion regulation and compassionate coping (C1-C5), therapist-led trauma narrative and cognitive processing delivered via videoconferencing and selected in-person sessions (C6), followed by in vivo mastery, conjoint caregiver-adolescent work, and future-oriented relapse prevention and recovery planning (C7-C9).\n\nCaregiver involvement follows TF-CBT principles and compassion-focused strategies and is integrated throughout treatment. Caregivers participate in the initial session and safety planning, complete parallel app-based modules during the stabilization phase.",[13],"Behavioral: Blended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C)",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)","ACTIVE_COMPARATOR","Participants assigned to this arm receive standard trauma-focused cognitive behavioral therapy (TF-CBT) delivered face-to-face and through videoconference in routine child and adolescent psychiatric care. Treatment follows the TF-CBT PRACTICE components, including psychoeducation, emotion regulation skills, cognitive coping, trauma narrative and processing, in vivo exposure, conjoint caregiver-adolescent sessions, and safety planning, with caregiver involvement according to the TF-CBT manual.",[19],"Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Blended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C)","Blended trauma-focused cognitive behavioral therapy with integrated compassion-focused strategies, combining therapist-led videoconferencing and selected in-person sessions with self-paced app-based modules. The intervention includes an initial introduction and safety planning, a stabilization phase with digital psychoeducation and compassion-based emotion regulation skills, therapist-led trauma narrative and cognitive processing, and a recovery phase focusing on in vivo mastery, caregiver-adolescent conjoint work, and relapse prevention. Caregivers participate throughout treatment, including parallel app-based modules during stabilization and selected therapist-led sessions.",[9],[27,28],"bTF-CBT-C","Blended TF-CBT with Compassion",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)","Standard trauma-focused cognitive behavioral therapy delivered face-to-face in routine child and adolescent psychiatric care. Treatment follows the TF-CBT PRACTICE components, including psychoeducation, affect regulation, cognitive coping, trauma narrative and processing, in vivo exposure, conjoint caregiver-adolescent sessions, and safety planning, with caregiver involvement according to the TF-CBT manual.",[15],[34],"TF-CBT",[36],{"name":37,"affiliation":5,"role":38},"Inga Dennhag, PhD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":37,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+46-706217414",null,"inga.dennhag@umu.se",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Linda Wallin, MD","+46-702101726","linda.wallin@umu.se",[50],{"facility":51,"status":52,"city":53,"state":43,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Umeå University, Clinical Science, Child- and Adolescent Psychiatry","RECRUITING","Umeå","901 87","Sweden","SE",{"type":58,"coordinates":59},"Point",[60,61],20.25972,63.82842,{"lat":61,"lon":60},[64,66],{"name":37,"role":41,"phone":65,"phoneExt":43,"email":44},"+4670-6217414",{"name":67,"role":41,"phone":68,"phoneExt":43,"email":48},"Linda Wallin, PhD Student","+4670-2101726",{"type":70,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR",[72,75,77,80,83],{"name":73,"class":74},"Region Västerbotten","OTHER_GOV",{"name":76,"class":6},"Region Norrbotten",{"name":78,"class":79},"Forte","INDUSTRY",{"name":81,"class":82},"Visare Norr","UNKNOWN",{"name":84,"class":82},"Stiftelsen Kempe-Carlgrenska Fonden","100624308","blended-trauma-focused-cognitive-behavioral-therapy-with-compassion-100624308",false,"NCT07407946","Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion","Blended (mHealth) Trauma-Focused Cognitive Behavioral Therapy With Compassion for Adolescents With Post-Traumatic Stress Disorder: Protocol for a Pilot Randomized Controlled Trial in Northern Sweden","b-TF-CBT-C","Inclusion Criteria:\n\n* Adolescents aged 12-17 years.\n* Meet DSM-5 criteria for post-traumatic stress disorder (PTSD) confirmed by diagnostic interview (MINI-KID).\n* Score ≥25 on the Child and Adolescent Trauma Screen (CATS-2) at baseline.\n* Receiving care within routine child and adolescent psychiatric services in participating regions.\n* Have a non-offending caregiver willing and able to participate in caregiver components of treatment.\n* Able to communicate in Swedish sufficiently to engage in treatment and assessments.\n* Provide informed assent\u002Fconsent, with caregiver consent according to age and regulations.\n\nExclusion Criteria:\n\n* Acute suicidality or risk requiring inpatient care.\n* Active psychotic disorder or severe dissociative symptoms that interfere with participation.\n* Autism spectrum disorder, severe eating disorder, or obsessive-compulsive disorder requiring primary specialized treatment.\n* Ongoing trauma exposure or unstable living conditions that would prevent safe participation.\n* Cognitive impairment or medical condition that precludes participation in psychotherapy or digital components.\n* Substance use disorder requiring treatment, or regular use of benzodiazepines (\\> once per week).\n* Concurrent trauma-focused psychotherapy or recent initiation\u002Fdiscontinuation of psychotropic medication (within the past 6 weeks), or planned medication changes during the study period.","ALL","12 Years","17 Years",{"count":97,"type":98},40,"ESTIMATED","INTERVENTIONAL",[101],"NA","Brief Summary\n\nThe goal of this clinical trial is to evaluate the feasibility and acceptability of a blended (mHealth) Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C) for adolescents with post-traumatic stress disorder (PTSD) in routine child and adolescent psychiatric services in northern Sweden. The main questions it aims to answer are:\n\n* Is bTF-CBT-C feasible to deliver in routine care, as indicated by recruitment, retention, adherence to sessions and app modules, data completeness, and adverse events?\n* Is bTF-CBT-C acceptable to adolescents, caregivers, and therapists, as indicated by satisfaction, therapeutic alliance, digital treatment evaluation, and qualitative interviews? Researchers will compare bTF-CBT-C to standard TF-CBT to explore whether the blended format shows similar or potentially improved patterns in clinical outcomes (e.g., PTSD symptoms, emotion regulation, and self-compassion) and to estimate variability needed to plan a future non-inferiority trial.\n\nParticipants will:\n\n* Complete eligibility screening and baseline assessments, including a diagnostic interview for PTSD.\n* Be randomized to either bTF-CBT-C or standard TF-CBT.\n* Receive trauma-focused treatment over time, with caregiver involvement in both groups.\n* In the bTF-CBT-C group, use a secure mobile app for stabilization modules and exercises, together with therapist-led video sessions and selected in-person meetings.\n* Complete assessments at baseline, after stabilization, post-treatment, and at 6-month follow-up, and provide feedback about their experiences (questionnaires and interviews).",[104],"Post-traumatic Stress Disorder (PTSD)",[106,107,30,108,109,110,111,112,113,114,115,116,117,118,119],"post-traumatic stress disorder (ptsd)","Adolescent","Blended psychotherapy","Digital mental health","mHealth intervention","Compassion-focused therapy","Self-compassion","Emotion regulation","Shame and self-criticism","Caregiver involvement","Child and adolescent psychiatry","Rural mental health","Telehealth","Pilot randomized controlled trial","2026-02-24",{"date":122,"type":123},"2026-02-27","ACTUAL",{"date":125,"type":123},"2026-02-23",{"date":127,"type":98},"2029-12-31",{"name":5,"class":6},1]