PTSD - Post Traumatic Stress DisorderNCT07052474
Intensive Trauma-Focused Treatment for Adolescents With PTSD: Feasibility and Preliminary Effects
An observational study of PTSD - Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder
- What is being tested?
- Intensive trauma-focused treatment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 12 Feb 2024to 30 Dec 2025
- How long will I take part?
- 5 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients referred to the CAP Stockholm Trauma unit
Who may be able to join
- Diagnosis of PTSD
- No or stable medication involving antidepressants, stimulants, and/or antipsychotics
- At least one caregiver can participate in the treatment
Who cannot join
- High risk for suicide
- IQ below 75
- Current substance abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Centre for Psychiatry Research
Stockholm, 17177
Maria Helander, PhD, +65 702798916, maria.helander@ki.se
About this study
Official title: Intensive Trauma-Focused Treatment for Adolescents With Post-Traumatic Stress Disorder (PTSD): Feasibility and Preliminary Effects
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.
Read more
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:
- 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:
- Therapists' ratings of whether they find the intensive trauma-focused treatment acceptable, appropriate, and feasible.
- The number of patients who complete the treatment without dropping out
- Patients' self-reported satisfaction with the treatment
- The proportion of patients with "adverse effects"
- 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:
- PTSD symptoms
- General mental health
Read the 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 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.
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Being tested
- Intensive trauma-focused treatment
- Keywords
- PTSD, Intensive treatment, Adolescents, Brief Intensive Trauma Treatment
- Medical subject headings
- Combat Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive trauma-focused treatmentBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Intensive trauma-focused treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at five weeks follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start12 Feb 2024
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 5 Weeks
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Maria Helander, Karolinska Institutet
- Investigators
- Maria Helander, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052474
- Sponsor's protocol ID
- DNR2023-06501-01
- Status last verified
- Sep 2025
- First submitted
- 26 Jun 2025
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD was not included in the ethical permission.
Publications
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.
PubMed 33029319Hendriks 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.
PubMed 29057522Ooms-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.
PubMed 34314951Wachen, 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.
PubMed 28851459Attkisson 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.
PubMed 10259963Goodman 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.
PubMed 11699809Dyregrov 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.
PubMed 8931390Nader, 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.
PubMed 35928521Van 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.
PubMed 30013726van 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.
PubMed 34025927Van 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.
PubMed 32454314Tinghog 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.
PubMed 39878600
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Trauma-Focused Treatment for Adolescents With Post-Traumatic Stress Disorder (PTSD): Feasibility and Preliminary Effects
- ClinicalTrials.gov ID
- NCT07052474
- Acronym / sponsor ID
- DNR2023-06501-01
- Conditions
- PTSD - Post Traumatic Stress Disorder
- Keywords
- PTSD, Intensive treatment, Adolescents, Brief Intensive Trauma Treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Therapists' ratings of whether they find the intensive trauma-focused treatment acceptable, appropriate, and feasible.
- The number of patients who complete the treatment without dropping out
- Patients' self-reported satisfaction with the treatment
- The proportion of patients with "adverse effects"
- 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:
- PTSD symptoms
- General mental health
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PTSD referred to the trauma unit at Child- and adolescent psychiatry, Stockholm | – | Behavioral: Intensive trauma-focused treatmentPatients 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. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients referred to the CAP Stockholm Trauma unit
Key inclusion criteria (3 listed)
- Diagnosis of PTSD
- No or stable medication involving antidepressants, stimulants, and/or antipsychotics
- At least one caregiver can participate in the treatment
Key exclusion criteria (3 listed)
- High risk for suicide
- IQ below 75
- Current substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive trauma-focused treatmentThe 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). | Behavioural | Patients with PTSD referred to the trauma unit at Child- and adolescent psychiatry, Stockholm |
Primary outcome
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), och Feasibility of Intervention Measure (FIM).
Time frame: From treatment start to five weeks after the intensive treatment week.
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.
5 secondary outcomes
Clinician-Administered PTSD Scale for DSM-5 - Child/Adolescent Version (CAPS-CA-5)
Time frame: Assessment before treatment start and five weeks after treatment week.
The Children Impact of Event Scale
Time frame: 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
Time frame: Pre treatment, one, two, four and five weeks post the treatment week
Strengths and Difficulties Questionnaire
Time frame: Assessment before treatment and at five weeks follow-up.
Client Satisfactory Questionnaire-8 (CSQ-8)
Time frame: Assessed at five weeks follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- BackgroundPynoos, 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: PubMed 33029319Mevissen 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.
- Background: PubMed 29057522Hendriks 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.
- Background: PubMed 34314951Ooms-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.
- BackgroundWachen, 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: PubMed 28851459Weiner 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.
- Background: PubMed 10259963Attkisson 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.
- Background: PubMed 11699809Goodman 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.
- Background: PubMed 8931390Dyregrov 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.
- BackgroundNader, 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: PubMed 35928521Sachser 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.
- Background: PubMed 30013726Van 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.
- Individual participant dataSharing planned: No. IPD was not included in the ethical permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Helander, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD - Post Traumatic Stress Disorder, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maja Vinnerljung, Psychologist (+46 8-123 531 00, maja.vinnerljung@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), och Feasibility of Intervention Measure (FIM). (time frame: From treatment start to five weeks after the intensive treatment week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07052474, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.