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Active, not recruiting Not applicable

8-day Intensive Treatment Programme for PTSD and CPTSD in Sweden

NCT06645028 · tracked via the Priya Life Science Sweden tracker
Sponsor
Christina Blomdahl
Phase
Not applicable
Started
2021-08-01
Last updated
2025-06-27

Condition(s) studied

PTSDComplex Post-Traumatic Stress Disorder

Investigational drug(s) / intervention(s)

Intensive treatment programmeTreatment as Usual (TAU)

Intensive treatment programme: Intervention Group: 8-day intensive treatment where each treatment day consists of the following schedule: Physical activity: 30 minutes Prolonged Exposure (PE): 90 minutes Physical activity: 30 minutes Lunch Physical activity: 60 minutes Eye Movement Desensitization and Reprocessing (EMDR): 90 minutes Physical activity: 30 minutes (omitted on days 4 and 8) Dinner Psychoeducation (omitted on days 4 and 8) Participants stay at the SÄS patient hotel during the treatment (with a three-day weekend break between treatment days 1-4 and 5-8). The treatment concept includes therapist rotation, meaning that participants switch therapists between PE and EMDR sessions. The purpose of this is to increase focus on the processing process rather than the relationship between the therapist and the client.

Treatment as Usual (TAU): Control group: 16 treatment sessions (90 minutes in duration) either Eye movement desensitisation and reprocessing (EMDR) or Prolonged Exposure (PE) in a standard outpatient format-weekly sessions. Participants can choose to attend 6 sessions of Psychoeducation for PTSD in a group format before starting EMDR or PE.

Study summary

Post-Traumatic Stress Disorder (PTSD) and Complex PTSD (C-PTSD) are conditions that may develop after a person has been exposed to extremely stressful experiences. The affected individual re-experiences the event despite attempts to avoid reminders of the experience and also experiences heightened tension. In C-PTSD, the individual also experiences significantly impaired ability to regulate emotions, severe negative change in self-image, and difficulty maintaining close relationships.

Traditional trauma-focused psychotherapy for PTSD typically involves one session per week over approximately 6-12 months. Intensive treatment models for both PTSD and C-PTSD have been developed and have shown promising results, with lower dropout rate from treatment compared to traditional treatments. The current project aims to compare the outcomes of an 8-day intensive treatment programme with treatment in a traditional format. Individuals with C-PTSD or PTSD who have not benefited from previous treatment attempts are included in the study. Participants are allocated to the respective treatment group according to principles of person-centered care, where participants are considered competent to make an informed choice of treatment method.

Diagnostic assessment and self-rating of symptoms of PTSD and C-PTSD are conducted before and after treatment, as well as at 3-month follow-up. The study is expected to provide increased knowledge on whether 8-day intensive treatment is a suitable alternative to treatment in a traditional format for PTSD and C-PTSD. The study is also expected to provide important data for considering whether 8-day intensive treatment should be widely implemented in Swedish psychiatry.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * CPTSD according to ICD-11 * PTSD with at least one comorbid disorder requiring psychiatric outpatient treatment * PTSD with previous unsuccessful trauma-focused treatment Exclusion Criteria: * ongoing substance or alcohol abuse * use of benzodiazepines * acute suicidality * dissociative identity disorder (DID) * insufficient knowledge of the Swedish language to complete questionnaires

Primary outcome measure(s)

  • Post Traumatic Checklist for DSM-5 (PCL-5) — Pre-treatment: 2 weeks before start. Posttreatment: 1 week after treatment. Follow-up: 3 months after treatment. Repeated measure at session 2,4,6,8,10,12,14. In ITP this corresponds to day 1-7 of treatment. TAU this corresponds to week 2-14 of treatm.
    Self-report measure of PTSD symptoms according to DSM-5 criteria. PCL-5 contains 20 items, rated on a 5-point scale (0 = "not at all" to 4 ("extremely"). It has shown good internal reliability (.96) and test-retest reliability (.84) (Bovin et al., 2016). PCL-5 has also demonstrated sensitivity to clinical change during treatment (Marx et al., 2022)

Trial sites (1)

FacilityCityRegionStatus
Södra Älvsborgs Sjukhus, Västra Götalandsregion Borås Sweden
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06645028 on ClinicalTrials.gov ↗ ← All trials in Sweden