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

NCT ID: NCT06645028

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2026-12-30

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.

Detailed Description

1. Study aims and research questions

The purpose of the study is to compare the outcomes and potential risks between two treatment methods for treatment-resistant PTSD and C-PTSD: 8-day intensive treatment and conventional treatment. Additionally, the study aims to investigate whether there are individual factors that influence the outcomes of each treatment format.

Specific research questions:

• Can a difference in the severity of PTSD and C-PTSD be observed after 8-day intensive treatment? Does the outcome differ compared to conventional treatment for PTSD and C-PTSD?

• Are there individual factors that influence the treatment outcome? Does the impact of these factors differ between the study groups?

• Does participation in 8-day intensive treatment pose an increased risk of adverse, harmful effects or an increase in suicidal intentions during and after the treatment?

2. Method

2.1 Participants

Participants consist of individuals referred to the Adult Psychiatric Outpatient Clinic for Psychosis and PTSD at Södra Älvsborgs Hospital between August 2021 and December 2023. Inclusion criteria for participation: diagnosis of C-PTSD or PTSD with previous treatment attempts that have not been effective. Exclusion criteria: insufficient knowledge of the Swedish language to respond to questionnaires, need for an interpreter during treatment, use of benzodiazepines, acute suicidality, or dissociative identity disorder. All individuals who meet the inclusion criteria during the recruitment period are asked about their willingness to participate.

We calculated differences between two independent groups with means. The calculation was based on the PCL-5 and the results from the study by Wortmann et al. (2016). The power calculation was performed using G*Power 3.1.9.4 (Faul et al., 2007) With a power of 0.80, a significance level of 0.05, a two-sided test, Group 1 had a difference of 10 (SD 15), and Group 2 had a difference of 2 (SD 13). The effect size was 0.56, which corresponds to a moderate effect. This results in a total sample of 100, i.e., 50 participants in each group.

2.2 Procedure

Allocation to each intervention group follows the principles of person-centered care, where participants are considered competent to be involved in their treatment choice. Participants are provided with written and verbal information about the treatment options and given the opportunity to ask questions in order to make an informed decision.

2.3 Data collection

Data is collected in the two following ways:

1. Through questionnaires and clinician ratings conducted during the inclusion assessment and follow-up after treatment, the following data is collected:

• Trauma history (LEC-5),

• Diagnosis of PTSD or C-PTSD (ITI 3.2),
• Self-assessment of dissociative symptoms (DES II),
• Clinician rating of suicidal intentions (SSI).

2. Data is collected via the REDcap database before, during, and after treatment completion. Participants receive a printed QR code for each assessment point and complete the assessments via mobile phone or computer. If needed, assessments can be done manually. The digital assessments include:

• Background information such as demographic data, sick leave status, employment, psychiatric treatment history, and ongoing treatment.
• Self-report questionnaires measuring PTSD symptoms (PCL-5), C-PTSD symptoms (ITQ), and transdiagnostic screening of psychiatric symptoms (DSM-5 CCM Level 1).

2.4. Data analysis

Analysis of group differences and exploratory analyses will be conducted using statistical software (SPSS for Windows). Differences in background data and baseline data between groups will be tested using the Chi-square (X²) test for categorical data and independent t-tests for numerical data, or alternatively, the Mann-Whitney U test if the criteria for parametric statistics are not met for numerical data.

• Data from all included participants completing basline assessment will be used, regardless of the number of completed assessments. Data that are possible statistical outliers will be included in the analysis if they are not outside the expected clinical range for the specific measure. Intent-to-treat (ITT) analysis will be applied to analyze outcomes related to repeated measurements (PCL-5 and ITQ). For this purpose, Linear Mixed Model (LMM) will be used, allowing for the inclusion of all available data from participants across all time points.

• Difference between groups will be analyzed for means and standard deviations. Results will be presented with levels of signifiance (p.05) and effectsize, including confidence intervals.
• Exploratory analysis of moderating individual factors (baseline symptom measurement, demographics, comorbidity, trauma history) that may influence treatment outcomes will be conducted using multiple regression analysis.

3. Expected outcomes and contributions fot the field of knowledge

The study is expected to provide increased knowledge on whether 8-day intensive treatment has an impact on symptoms in treatment-resistant forms of PTSD and C-PTSD, and whether its effectiveness differs from traditional treatment. The study is also anticipated to enhance understanding of whether individual factors play a role in the choice of treatment.

Overall, the study aims to provide important insights into intensive treatment for C-PTSD and treatment-resistant PTSD in a Swedish context. This knowledge is expected to contribute to decisions on whether intensive treatment should be implemented in Swedish psychiatry.

Conditions

PTSD; Complex Post-Traumatic Stress Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Intensive treatment programme

Intervention Type: 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.

Treatment as usual

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.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual (TAU)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

EMDR; Prolonged Exposure; Prolonged Exposure; EMDR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: collaborator

Sodra Alvsborgs Hospital

OTHER

Sponsor Role: collaborator

Christina Blomdahl

OTHER_GOV

Sponsor Role: lead

Responsible Party

Christina Blomdahl

R & D Strategic

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christina Blomdahl, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Sandra Weineland, Associate Professor

Role: STUDY_DIRECTOR

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

Locations

Södra Älvsborgs Sjukhus, Västra Götalandsregion

Borås, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 30013726 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32598561 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33029323 (View on PubMed)

Related Links

https://www.researchweb.org/is/se/vgr/project/280348

Description of the project in Swedish

Other Identifiers

280348

Identifier Type: -

Identifier Source: org_study_id