Intensive Trauma-Focused Treatment for Adolescents With PTSD: Feasibility and Preliminary Effects
NCT ID: NCT07052474
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2024-02-12
2025-12-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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 TF-CBT for children and adolescents (Cohen \& Mannarino, 2008) as well as the standard EMDR protocol (Shapiro, 2018).
Interventions
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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 standard EMDR protocol (Shapiro, 2018).
Eligibility Criteria
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Inclusion Criteria
* No or stable medication involving antidepressants, stimulants, and/or antipsychotics
* At least one caregiver can participate in the treatment
Exclusion Criteria
* IQ below 75
* Current substance abuse
13 Years
17 Years
ALL
No
Sponsors
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Region Stockholm
OTHER_GOV
Karolinska Institutet
OTHER
Responsible Party
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Maria Helander
PhD, Licenced psychologist
Principal Investigators
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Maria Helander, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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Centre for Psychiatry Research
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Dyregrov A, Kuterovac G, Barath A. Factor analysis of the impact of event scale with children in war. Scand J Psychol. 1996 Dec;37(4):339-50. doi: 10.1111/j.1467-9450.1996.tb00667.x.
Nader, K., Kriegler, K. A., Blake, D. D., Pynoos, R. S., Newman, E., & Weathers, F. W. (1996). Clinician-administered PTSD scale for children and adolescents.
Sachser C, Berliner L, Risch E, Rosner R, Birkeland MS, Eilers R, Hafstad GS, Pfeiffer E, Plener PL, Jensen TK. The child and Adolescent Trauma Screen 2 (CATS-2) - validation of an instrument to measure DSM-5 and ICD-11 PTSD and complex PTSD in children and adolescents. Eur J Psychotraumatol. 2022 Aug 1;13(2):2105580. doi: 10.1080/20008066.2022.2105580. eCollection 2022.
Van Woudenberg C, Voorendonk EM, Bongaerts H, Zoet HA, Verhagen M, Lee CW, van Minnen A, De Jongh A. Effectiveness of an intensive treatment programme combining prolonged exposure and eye movement desensitization and reprocessing for severe post-traumatic stress disorder. Eur J Psychotraumatol. 2018 Jul 10;9(1):1487225. doi: 10.1080/20008198.2018.1487225. eCollection 2018.
van Pelt Y, Fokkema P, de Roos C, de Jongh A. Effectiveness of an intensive treatment programme combining prolonged exposure and EMDR therapy for adolescents suffering from severe post-traumatic stress disorder. Eur J Psychotraumatol. 2021 May 14;12(1):1917876. doi: 10.1080/20008198.2021.1917876.
Van Minnen A, Voorendonk EM, Rozendaal L, de Jongh A. Sequence matters: Combining Prolonged Exposure and EMDR therapy for PTSD. Psychiatry Res. 2020 Aug;290:113032. doi: 10.1016/j.psychres.2020.113032. Epub 2020 May 16.
Tinghog P, Vagbratt L, Jennstal J, Bragesjo M, Moller N. Acceptability and Preliminary Effects of Intensive Brief Trauma-Focused PTSD Treatment for Refugees. Torture. 2024;34(3):54-63. doi: 10.7146/torture.v34i3.147953.
Simmons C, Meiser-Stedman R, Baily H, Beazley P. A meta-analysis of dropout from evidence-based psychological treatment for post-traumatic stress disorder (PTSD) in children and young people. Eur J Psychotraumatol. 2021 Aug 5;12(1):1947570. doi: 10.1080/20008198.2021.1947570. eCollection 2021.
Shapiro, F. (2007). EMDR, Adaptive Information Processing, and Case Conceptualization. Journal of EMDR Practice and Research, 1(2), 68-87. https://doi.org/10.1891/1933-3196.1.2.68
John-Baptiste Bastien R, Jongsma HE, Kabadayi M, Billings J. The effectiveness of psychological interventions for post-traumatic stress disorder in children, adolescents and young adults: a systematic review and meta-analysis. Psychol Med. 2020 Jul;50(10):1598-1612. doi: 10.1017/S0033291720002007. Epub 2020 Jun 22.
Post-traumatic stress disorder NICE guideline. (2018). www.nice.org.uk/guidance/ng116
Pietrzak RH, Goldstein RB, Southwick SM, Grant BF. Psychiatric comorbidity of full and partial posttraumatic stress disorder among older adults in the United States: results from wave 2 of the National Epidemiologic Survey on Alcohol and Related Conditions. Am J Geriatr Psychiatry. 2012 May;20(5):380-90. doi: 10.1097/JGP.0b013e31820d92e7.
Cohen JA, Deblinger E, Mannarino AP. Trauma-focused cognitive behavioral therapy for children and families. Psychother Res. 2018 Jan;28(1):47-57. doi: 10.1080/10503307.2016.1208375. Epub 2016 Jul 22.
Albisser, N., Westerveld, M., Kooij, L., de Keizer-Altink, M., & Lindauer, R. (2024). Korte intensieve traumabehandeling bij jongeren. Kind & Adolescent Praktijk, 23(3), 16-24. https://doi.org/10.1007/s12454-024-1833-1
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Other Identifiers
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DNR2023-06501-01
Identifier Type: -
Identifier Source: org_study_id
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