Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06645028
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
8-day Intensive Treatment Programme for PTSD and CPTSD in Sweden
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of an 8-day Intensive Treatment Programme for PTSD and CPTSD in the Swedish Mental Health Care
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
8-day ITP
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
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
21 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 GPower 3194 Faul et al 2007 With a power of 080 a significance level of 005 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 056 which corresponds to a moderate effect This results in a total sample of 100 ie 50 participants in each group
22 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
23 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 32
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
24 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 p05 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
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
21 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 GPower 3194 Faul et al 2007 With a power of 080 a significance level of 005 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 056 which corresponds to a moderate effect This results in a total sample of 100 ie 50 participants in each group
22 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
23 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 32
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
24 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 p05 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None