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Clinical Trial NCT07052474 for PTSD - Post Traumatic Stress Disorder is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Intensive Trauma-Focused Treatment for Adolescents With PTSD: Feasibility and Preliminary Effects 20 Adolescent

Recruiting
Clinical Trial NCT07052474 is an observational study for PTSD - Post Traumatic Stress Disorder that is recruiting. It started on February 12, 2024 with plans to enroll 20 participants. Led by Karolinska Institutet, it is expected to complete by December 30, 2025. The latest data from ClinicalTrials.gov was last updated on September 23, 2025.
Brief Summary
Post-Traumatic Stress Disorder (PTSD) in adolescents is a debilitating condition that, without timely intervention, risks becoming chronic and severely impairing development. Although evidence-based treatments such as Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Eye Movement Desensitization and Reprocessing (EMDR) are effective, they typically require weekly sessions over 6-9 months, which many adolescent...Show More
Detailed Description
Background Post-Traumatic Stress Disorder (PTSD) is associated with a high risk of chronicity if untreated. Rapid and effective interventions are crucial for reducing symptom burden and preventing long-term complications. According to NICE treatment guidelines, the two primary recommended treatments for PTSD in children and adolescents are Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) and Eye Movement Desensit...Show More
Official Title

Intensive Trauma-Focused Treatment for Adolescents With Post-Traumatic Stress Disorder (PTSD): Feasibility and Preliminary Effects

Conditions
PTSD - Post Traumatic Stress Disorder
Publications
Scientific articles and research papers published about this clinical trial:
  • Pynoos, R. S., Weathers, F. W., Steinberg, A. M., Marx, B. P., Layne, C. M., Kaloupek, D. G., ... & Kriegler, J. A. (2015). Clinician-administered PTSD scale for DSM-5-child/adolescent version. Scale available from the National Center for PTSD at www. ptsd. va. gov.
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Other Study IDs
  • DNR2023-06501-01
NCT ID Number
Start Date (Actual)
2024-02-12
Last Update Posted
2025-09-23
Completion Date (Estimated)
2025-12-30
Enrollment (Estimated)
20
Study Type
Observational
Status
Recruiting
Keywords
PTSD
Intensive treatment
Adolescents
Brief Intensive Trauma Treatment
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Patients with PTSD referred to the trauma unit at Child- and adolescent psychiatry, Stockholm
Patients included in the study receive one week of intensive trauma-focused treatment where two different evidence-based treatments are combined with physical activity and family support.
Intensive trauma-focused treatment
The treatment program includes components of Trauma focused cognitive behavioral therapy (TF-CBT), Eye Movement Desensitization and Reprocessing Therapy (EMDR), physical activity, as well as parent sessions. The intensive treatment largely follows the Dutch intensive trauma treatment program "Korte Intensieve Traumabehandeling" (KIT) (Albisser et al., 2024). The intensive treatment incorporates core components from ...Show More
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), och Feasibility of Intervention Measure (FIM).
The therapist rated measures of how acceptable, appropriate, and feasible the treatment is perceived. The measures consist of three scales with four items each and have demonstrated strong psychometric properties. Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Minimum value 4, maximum value 20. A higher value indicates a better outcome. To consider the intervention acceptable, appropriate, and feasible, at least 80% of clinicians must rate the method above 50 on a 0-100 scale on the AIM, IAM, and FIM subscales.
From treatment start to five weeks after the intensive treatment week.
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5)
The CAPS-CA-5 is a structured diagnostic interview assessing PTSD diagnosis. It contains 30 items and assesses symptom severity by combining frequency and intensity ratings on a 0-4 scale, minimum value = 0, maximum value = 120 CAPS-CA-5 total symptom severity score is calculated by summing severity scores for the 20 DSM-5 PTSD symptoms. Similarly, CAPS-CA-5 symptom cluster severity scores are calculated by summing the individual item severity scores for symptoms corresponding to a given DSM-5 cluster: Criterion B (items 1-5); Criterion C (items 6-7); Criterion D (items 8-14); and, Criterion E (items 15-20). PTSD diagnostic status is determined by first dichotomizing each symptom as "present" or "absent," then following the DSM-5 diagnostic rule. A symptom is considered present only if the corresponding item severity score is rated 2 ("moderate/threshold") or higher.
Assessment before treatment start and five weeks after treatment week.
The Children Impact of Event Scale
CRIES-13 is a 13-item scale assessing PTSD symptoms using a four-point Likert scale (Not at all, Rarely, Sometimes, Often), scored 0,1,3,5 with no reversed items. It includes subscales for intrusion (four items), avoidance (four items), and arousal (five items). The total score thus ranges from 0 to 65 on this 13-item scale. A higher score indicates a worse outcome in terms of PTSD symptom burden.
Before treatment, every day during the five-day intensive treatment, and at one, two, four, and five weeks post the treatment week.
Child and adolescent trauma screen 2
Trauma symptoms are assessed using the CATS-2, both for the adolescent (CATS-2-U) and for the caregiver (CATS-2-F). This trauma questionnaire screens for both trauma history and trauma symptoms based on DSM-5 criteria. The CATS-2 consists of two parts. Part one is a screening for potentially traumatic events at any point in the individual's life, comprising 15 items where the patient can answer YES or NO. Part two is a screening for post-traumatic symptoms over the past four weeks, with 20 items and five questions about how the child's daily life has been impacted by these symptoms. The total score for CATS-2-U may vary between 0 and 60 points. Each item is rated on a four-point Likert scale between 0 (never) to 3 (almost always), and the total score is calculated by summing the answers from each item. A higher score indicates a worse outcome.
Pre treatment, one, two, four and five weeks post the treatment week
Strengths and Difficulties Questionnaire
The Strengths and Difficulties Questionnaire is a 25-item scale assessing general psychological functioning. A total difficulties score is generated by summing scores from all the scales except the prosocial scale, with a minimum value of 0 to a maximum value of 40. Each subscale consists of 5 items each (range 0-2 from "not true", to "certainly true". A higher score indicates a worse outcome.
Assessment before treatment and at five weeks follow-up.
Client Satisfactory Questionnaire-8 (CSQ-8)
The Client Satisfaction Questionnaire-8 is an 8-item self-report scale measuring satisfaction with treatment. Items are scored on a Likert scale from 1 (low satisfaction) to 4 (high satisfaction) with different descriptors for each response point. Total scores range from 8 to 32, with higher scores indicating greater satisfaction.
Assessed at five weeks follow-up.
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Minimum Age
13 Years
Eligible Sexes
All

Inclusion Criteria:

  • Diagnosis of PTSD
  • No or stable medication involving antidepressants, stimulants, and/or antipsychotics
  • At least one caregiver can participate in the treatment

  • High risk for suicide
  • IQ below 75
  • Current substance abuse
Karolinska Institutet logoKarolinska Institutet450 active studies to explore
Region Stockholm logoRegion Stockholm
Study Responsible Party
Maria Helander, Principal Investigator, PhD, Licenced psychologist, Karolinska Institutet
Study Central Contact
Contact: Maja Vinnerljung, Psychologist, +46 8-123 531 00, [email protected]
Contact: Maria Helander, PhD, Psychologist, +46 702 798916, [email protected]
1 Study Locations in 1 Countries
Centre for Psychiatry Research, Stockholm, 17177, Sweden
Maria Helander, PhD, Contact, +65 702798916, [email protected]
Recruiting