NCT07052474

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 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. 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:
  2. 2.Therapists' ratings of whether they find the intensive trauma-focused treatment acceptable, appropriate, and feasible.
  3. 3.The number of patients who complete the treatment without dropping out
  4. 4.Patients' self-reported satisfaction with the treatment
  5. 5.The proportion of patients with "adverse effects"
  6. 6.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:
  7. 7.PTSD symptoms
  8. 8.General mental health

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2024

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 4, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

September 23, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

June 26, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

PTSDIntensive treatmentAdolescentsBrief Intensive Trauma Treatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5)

    Assessment before treatment start and five weeks after treatment week.

  • The Children Impact of Event Scale

    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

    Pre treatment, one, two, four and five weeks post the treatment week

  • Strengths and Difficulties Questionnaire

    Assessment before treatment and at five weeks follow-up.

  • Client Satisfactory Questionnaire-8 (CSQ-8)

    Assessed at five weeks follow-up.

Other Outcomes (2)

  • Adverse effects checklist

    Daily during the treatment period and at one, two, four and five weeks post treatment week

  • Drop out of treatment

    Any treatment dropout during the five-day treatment period.

Study Arms (1)

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.

Behavioral: Intensive trauma-focused treatment

Interventions

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).

Patients with PTSD referred to the trauma unit at Child- and adolescent psychiatry, Stockholm

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients referred to the CAP Stockholm Trauma unit

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Psychiatry Research

Stockholm, 17177, Sweden

RECRUITING

Related Publications (22)

  • 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.

    BACKGROUND
  • 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: 33029319BACKGROUND
  • 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: 29057522BACKGROUND
  • 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: 34314951BACKGROUND
  • 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

    BACKGROUND
  • 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: 28851459BACKGROUND
  • 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: 10259963BACKGROUND
  • 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: 11699809BACKGROUND
  • 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.

    PMID: 8931390BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 35928521BACKGROUND
  • 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.

    PMID: 30013726BACKGROUND
  • 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.

    PMID: 34025927BACKGROUND
  • 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.

    PMID: 32454314BACKGROUND
  • 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.

    PMID: 39878600BACKGROUND
  • 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.

    PMID: 34377359BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 32624017BACKGROUND
  • Post-traumatic stress disorder NICE guideline. (2018). www.nice.org.uk/guidance/ng116

    BACKGROUND
  • 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.

    PMID: 22522959BACKGROUND
  • 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.

    PMID: 27449400BACKGROUND
  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Combat DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Maria Helander, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maja Vinnerljung, Psychologist

CONTACT

Maria Helander, PhD, Psychologist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Licenced psychologist

Study Record Dates

First Submitted

June 26, 2025

First Posted

July 4, 2025

Study Start

February 12, 2024

Primary Completion

October 30, 2025

Study Completion

December 30, 2025

Last Updated

September 23, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

IPD was not included in the ethical permission.

Locations