Меню
Идёт набор NCT07052474

Intensive Trauma-Focused Treatment for Adolescents With PTSD: Feasibility and Preliminary Effects

Наблюдательное PTSD - Post Traumatic Stress Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intensive trauma-focused treatment.
Кому может быть актуально
Состояния в реестре: PTSD - Post Traumatic Stress Disorder. Базовые параметры: 13 лет — 17 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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 adolescents struggle to complete. High dropout rates remain a significant clinical challenge. Intensive trauma-focused interventions have shown promising outcomes in adults, including rapid symptom reduction and improved retention. Inspired by a Dutch model, this project evaluates a Swedish adaptation of Korte Intensieve Traumabehandeling (KIT), which combines EMDR, elements of TF-CBT, physical activity, and parental support in a 5-day intensive treatment. This project is a pilot study to examine the feasibility, early effects, and practicality of intensive trauma-focused therapy. The pilot study is the first step toward planning a larger, controlled study in Swedish child and adolescent psychiatry. The following questions are included in the project: 1. Is intensive trauma-focused psychological treatment with EMDR, components of TF-CBT, combined with physical activity and a parent group a feasible, suitable, and acceptable treatment method for PTSD within Swedish child and adolescent psychiatry in terms of: 1. Therapists' ratings of whether they find the intensive trauma-focused treatment acceptable, appropriate, and feasible. 2. The number of patients who complete the treatment without dropping out 3. Patients' self-reported satisfaction with the treatment 4. The proportion of patients with "adverse effects" 2. Does intensive trauma-focused psychological treatment with EMDR, components of TF-CBT, combined with physical activity and a parent group for PTSD, lead to a decrease in symptoms in the expected direction in terms of: 1. PTSD symptoms 2. General mental health

Подробное описание

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 Desensitization and Reprocessing (EMDR), both of which are supported by substantial empirical evidence. These treatments typically involve 6-9 months of weekly sessions.

A notable challenge in treating adolescents with PTSD is the high rate of premature treatment termination. Increasing treatment intensity may reduce dropout rates, as studies indicate that more frequent sessions lead to greater symptom reduction and improved retention. In adult populations, intensive programs that combine evidence-based therapies such as EMDR and Prolonged Exposure (PE), alongside physical activity and psychoeducation, have shown promising results, including significant symptom reduction and lower dropout rates.

While EMDR and exposure-based therapies share some similarities, they operate through different mechanisms. TF-CBT utilizes continuous exposure to facilitate habituation and fear extinction, whereas EMDR employs dual attention stimulation, often via eye movements. The hypothesis that combining both approaches can enhance treatment effects through complementary mechanisms requires further investigation, particularly in an intensive format.

For adolescents, treatment protocols similar to those developed for adults have emerged, evaluating variations of 5-8 days of intensive treatment that integrate therapeutic modalities such as EMDR and CBT-based treatments like PE or TF-CBT, along with parental support and physical activity. In the Netherlands, a Brief Intensive Trauma Treatment (KIT; Korte Intensieve Traumabehandeling) model has been developed, which combines EMDR with TF-CBT, physical exercise, and parental support.

Despite promising outcomes indicating rapid symptom alleviation-often within a week-existing research on intensive trauma treatments for children and adolescents is limited. Notably, no randomized controlled trials (RCTs) have been published, and many studies lack control groups. Observed results suggest that the majority of participants no longer meet PTSD diagnostic criteria post-treatment while reporting reduced depressive symptoms. However, methodological limitations call for cautious interpretation of these findings.

This project is designed as a feasibility study utilizing a within-group design to assess the viability and preliminary effects of a Swedish adaptation of the KIT model. This intensive five-day trauma-focused intervention will incorporate EMDR and TF-CBT elements alongside physical activity and parent sessions, targeting adolescents with PTSD referred to the Child and Adolescent Psychiatry (CAP) Trauma Unit in Stockholm. Ethical approval for the study has been granted (Dnr 2024-05726-02).

Time points for data assessment Data is collected at baseline and at five weeks post treatment week for all measures. In addition, two of the measures are collected with higher intensity, the CRIES 13, self rated measure of PTSD symptoms is collected daily during the treatment week and at one and two weeks post treatment. The CATS 2 is assessed at one and two weeks post treatment by both the patient and the caregiver.

Data Analysis As a pilot study with a limited sample size, inferential statistics are not planned. Instead, changes in PTSD symptoms and mental health will be examined descriptively. Planned analyses include within-group effect sizes, proportion of treatment drop-out, and proportions of patients in full or partial remission. Attrition rates will be compared to dropout rates reported in earlier studies.

Вмешательства

  • Поведенческое 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 TF-CBT for children and adolescents (Cohen \& Mannarino, 2008) as well as the st

Первичные конечные точки

  • Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), och Feasibility of Intervention Measure (FIM). [Срок оценки: From treatment start to five weeks after the intensive treatment week.]
Вторичные конечные точки (5)
  • Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5) [Срок оценки: Assessment before treatment start and five weeks after treatment week.]
  • The Children Impact of Event Scale [Срок оценки: 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 [Срок оценки: Pre treatment, one, two, four and five weeks post the treatment week]
  • Strengths and Difficulties Questionnaire [Срок оценки: Assessment before treatment and at five weeks follow-up.]
  • Client Satisfactory Questionnaire-8 (CSQ-8) [Срок оценки: Assessed at five weeks follow-up.]

Критерии участия

Patients with PTSD between 13 and 17 years of age who are referred to the specialized trauma unit within Stockholm Child and Adolescent Psychiatry. Patients who meet inclusion criteria after assessment at the BUP Trauma Unit are informed about the study. If interested, they attend a meeting to receive further information and provide consent. Background data is collected, and a diagnostic interview (CAPS-CA-5) is scheduled. Inclusion is decided during treatment planning meetings.

Критерии включения

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

Критерии исключения

  • High risk for suicide
  • IQ below 75
  • Current substance abuse

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швеция · 1 центр
  • Centre for Psychiatry Research — Stockholm

Публикации

  • 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.
  • Mevissen L, Ooms-Evers M, Serra M, de Jongh A, Didden R. Feasibility and potential effectiveness of an intensive trauma-focused treatment programme for families with PTSD and mild intellectual disability. Eur J Psychotraumatol. 2020 Jul 14;11(1):1777809. doi: 10.1080/20008198.2020.1777809. PMID 33029319
  • Hendriks L, de Kleine RA, Heyvaert M, Becker ES, Hendriks GJ, van Minnen A. Intensive prolonged exposure treatment for adolescent complex posttraumatic stress disorder: a single-trial design. J Child Psychol Psychiatry. 2017 Nov;58(11):1229-1238. doi: 10.1111/jcpp.12756. Epub 2017 Jun 14. PMID 29057522
  • Ooms-Evers M, van der Graaf-Loman S, van Duijvenbode N, Mevissen L, Didden R. Intensive clinical trauma treatment for children and adolescents with mild intellectual disability or borderline intellectual functioning: A pilot study. Res Dev Disabil. 2021 Oct;117:104030. doi: 10.1016/j.ridd.2021.104030. Epub 2021 Jul 24. PMID 34314951
  • Wachen, J. S., Dondanville, K. A., Evans, W. R., Morris, K., & Cole, A. (2019). Adjusting the Timeframe of Evidence-Based Therapies for PTSD-Massed Treatments. In Current Treatment Options in Psychiatry (Vol. 6, Issue 2, pp. 107-118). Springer. https://doi.org/10.1007/s40501-019-00169-9
  • Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. PMID 28851459
  • Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x. PMID 10259963
  • Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015. PMID 11699809

Идентификаторы

NCT: NCT07052474 · DNR2023-06501-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗