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

NCT06645028 | Active Not Recruiting

• 1 other identifier: 280348
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD; Complex Post-Traumatic Stress Disorder

Keywords

Intensive treatment programme; EMDR; Prolonged exposure; Physical activity

Outcome Measures

Primary Outcomes (1)

• Post Traumatic Checklist for DSM-5 (PCL-5)

  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)

  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.

Secondary Outcomes (1)

• International Trauma Questionnaire (ITQ)

  Pre-treatment: 2 weeks before start. Posttreatment: 1 week after treatment. Follow-up: 3 months after treatment.

Other Outcomes (1)

• International Trauma Interview (ITI) 3.2 (test version)

  Pre-treatment: 2 weeks before start. Posttreatment: 1 week after treatment. Follow-up: 3 months after treatment.

Study Arms (2)

Intensive treatment programme

EXPERIMENTAL

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.

Behavioral: Intensive treatment programme

Treatment as usual

ACTIVE COMPARATOR

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.

Behavioral: Treatment as Usual (TAU)

Interventions

Intensive treatment programme BEHAVIORAL

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.

Also known as: EMDR, Prolonged Exposure

Intensive treatment programme

Treatment as Usual (TAU) BEHAVIORAL

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.

Also known as: Prolonged Exposure, EMDR

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CPTSD according to ICD-11
• PTSD with at least one comorbid disorder requiring psychiatric outpatient treatment
• PTSD with previous unsuccessful trauma-focused treatment

You may not qualify if:

• ongoing substance or alcohol abuse
• use of benzodiazepines
• acute suicidality
• dissociative identity disorder (DID)
• insufficient knowledge of the Swedish language to complete questionnaires

Sponsors & Collaborators

• Christina Blomdahl: lead
• Vastra Gotaland Region: collaborator
• Sodra Alvsborgs Hospital: collaborator

Study Sites (1)

Södra Älvsborgs Sjukhus, Västra Götalandsregion

Borås, 50182, Sweden

Location

Related Publications (3)

• 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: 30013726 BACKGROUND

• Sciarrino NA, Warnecke AJ, Teng EJ. A Systematic Review of Intensive Empirically Supported Treatments for Posttraumatic Stress Disorder. J Trauma Stress. 2020 Aug;33(4):443-454. doi: 10.1002/jts.22556. Epub 2020 Jun 29.

  PMID: 32598561 BACKGROUND

• Voorendonk EM, De Jongh A, Rozendaal L, Van Minnen A. Trauma-focused treatment outcome for complex PTSD patients: results of an intensive treatment programme. Eur J Psychotraumatol. 2020 Jul 23;11(1):1783955. doi: 10.1080/20008198.2020.1783955.

  PMID: 33029323 BACKGROUND

Related Links

• Description of the project in Swedish

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Motor Activity

Interventions

Eye Movement Desensitization Reprocessing; Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christina Blomdahl, PhD

  REDI, Primary Health Care, Västra Götalands Region (VGR)

  PRINCIPAL INVESTIGATOR

• Sandra Weineland, Associate Professor

  Dpt of Psychology, Gothenburg University; REDI, Primary Health Care, VGR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: R & D Strategic

Model Details: Open clinical trail where participants are allocated via shared desicion making

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 16, 2024
• Study Start: August 1, 2021
• Primary Completion: October 30, 2024
• Study Completion (Estimated): December 30, 2026
• Last Updated: June 27, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)