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Blended Trauma-Focused Cognitive Behavioral Therapy With Compassion

RecruitingNAAges 12 Years - 17 YearsAllUmeå University
NCT07407946 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Brief Summary The 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: * 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? * 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, em

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📋 Eligibility rules (as published)
Inclusion Criteria: * Adolescents aged 12-17 years. * Meet DSM-5 criteria for post-traumatic stress disorder (PTSD) confirmed by diagnostic interview (MINI-KID). * Score ≥25 on the Child and Adolescent Trauma Screen (CATS-2) at baseline. * Receiving care within routine child and adolescent psychiatric services in participating regions. * Have a non-offending caregiver willing and able to participate in caregiver components of treatment. * Able to communicate in Swedish sufficiently to engage in treatment and assessments. * Provide informed assent/consent, with caregiver consent according to age and regulations. Exclusion Criteria: * Acute suicidality or risk requiring inpatient care. * Active psychotic disorder or severe dissociative symptoms that interfere with participation. * Autism spectrum disorder, severe eating disorder, or obsessive-compulsive disorder requiring primary specialized treatment. * Ongoing trauma exposure or unstable living conditions that would prevent safe participation. * Cognitive impairment or medical condition that precludes participation in psychotherapy or digital components. * Substance use disorder requiring treatment, or regular use of benzodiazepines (\> once per week). * Concurrent trauma-focused psychotherapy or recent initiation/discontinuation of psychotropic medication (within the past 6 weeks), or planned medication changes during the study period.
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What it tests

  • Blended Trauma-Focused Cognitive Behavioral Therapy with Compassion (bTF-CBT-C)
  • Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)
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Where

1 site
Umeå University, Clinical Science, Child- and Adolescent Psychiatry
Umeå, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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