Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588309
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
The Course and Outcome of Integreated Trauma and Addiction Treatment Between PTSD and CPTSD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Whats in a Name Do PTSD and Complex PTSD Diagnoses Predict Differences in Course and Outcome of Integrated Addiction and Trauma Focused Treatment
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
In the ICD-11 post-traumatic stress disorder PTSD and complex PTSD CPTSD are distinguished CPTSD is associated with early childhood traumatization and more severe symptom patterns Research thus far confirms that PTSD and CPTSD are two related but different concepts but its still unclear what the clinical relevance of this differentiation is In addiction care approximately one out of three patients suffer from CPTSD Its unclear if in patients with a substance use disorder SUD comorbid CPTSD results in poorer treatment outcomes compared to comorbid PTSD
Detailed Description:
Rationale In the ICD-11 post-traumatic stress disorder PTSD and complex PTSD CPTSD are distinguished CPTSD is associated with early childhood traumatization and more severe symptom patterns Research thus far confirms that PTSD and CPTSD are two related but different concepts but its still unclear what the clinical relevance of this differentiation is In addiction care approximately one out of three patients suffer from CPTSD Its unclear if in patients with a substance use disorder SUD comorbid CPTSD results in poorer treatment outcomes compared to comorbid PTSD
Objective To determine differences in course and outcome of integrated trauma-focused treatment delivered alongside addiction treatment in participants with comorbid PTSD and CPTSD
Study design An observational prospective study with two groups N 50 allocation ratio 11 of participants with a SUD One group has a comorbid PTSD n 25 and the other a comorbid CPTSD n 25 Assessments take place at baseline T0 after every trauma- focused treatment session T11-9 and after 10 weeks during which trauma-focused treatment may or may not have been completed or prematurely terminated T2
Study population Patients with SUD and either comorbid PTSD or CPTSD aged 18 years with good Dutch language proficiency who receive addiction treatment and trauma-focused treatment and who provide written informed consent
Intervention Treatment as usual TAU in accordance with the Dutch clinical practice guidelines consists of 1 addiction treatment according to the Community Reinforcement Approach henceforth CRA and 2 trauma-focused treatment EMDR-therapy henceforth EMDR
Main study parametersendpoints Changes in PTSD symptom severity in participants with comorbid PTSD and CPTSD from T0 to T2 as measured by the PCL-5 and CAPS-5
Nature and extent of the burden and risks associated with participation benefit and group relatedness All participants receive TAU both CRA and EMDR including standardized assessments Additionally participants fill in one extra questionnaire ITQ at T0 and T2 and the CAPS is administered additionally at T2 The extra burden of filling the ITQ is approximately one minute and for the CAPS approximately ten to forty-five minutes depending on the amount of symptoms after trauma treatment Given the observational nature of the study no risks related to the study are expected beyond those associated with routine clinical addiction care eg relapse
To optimize data-collection especially after termination of EMDR before T2 assessment participants receive an incentive a voucher worth 10 euro after completing the baseline T0 assessment and the first five PCL-5 assessments T11-5 and a voucher worth 15 euro after completing the next four PCL-5 assessments T16-9 and the final assessment T2
Objective To determine differences in course and outcome of integrated trauma-focused treatment delivered alongside addiction treatment in participants with comorbid PTSD and CPTSD
Study design An observational prospective study with two groups N 50 allocation ratio 11 of participants with a SUD One group has a comorbid PTSD n 25 and the other a comorbid CPTSD n 25 Assessments take place at baseline T0 after every trauma- focused treatment session T11-9 and after 10 weeks during which trauma-focused treatment may or may not have been completed or prematurely terminated T2
Study population Patients with SUD and either comorbid PTSD or CPTSD aged 18 years with good Dutch language proficiency who receive addiction treatment and trauma-focused treatment and who provide written informed consent
Intervention Treatment as usual TAU in accordance with the Dutch clinical practice guidelines consists of 1 addiction treatment according to the Community Reinforcement Approach henceforth CRA and 2 trauma-focused treatment EMDR-therapy henceforth EMDR
Main study parametersendpoints Changes in PTSD symptom severity in participants with comorbid PTSD and CPTSD from T0 to T2 as measured by the PCL-5 and CAPS-5
Nature and extent of the burden and risks associated with participation benefit and group relatedness All participants receive TAU both CRA and EMDR including standardized assessments Additionally participants fill in one extra questionnaire ITQ at T0 and T2 and the CAPS is administered additionally at T2 The extra burden of filling the ITQ is approximately one minute and for the CAPS approximately ten to forty-five minutes depending on the amount of symptoms after trauma treatment Given the observational nature of the study no risks related to the study are expected beyond those associated with routine clinical addiction care eg relapse
To optimize data-collection especially after termination of EMDR before T2 assessment participants receive an incentive a voucher worth 10 euro after completing the baseline T0 assessment and the first five PCL-5 assessments T11-5 and a voucher worth 15 euro after completing the next four PCL-5 assessments T16-9 and the final assessment T2
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