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临床试验/NCT06588309
NCT06588309招募中不适用

What's in a Name? Do PTSD and Complex PTSD Diagnoses Predict Differences in Course and Outcome of Integrated Addiction and Trauma Focused Treatment?

IrisZorg0 个研究点目标入组 50 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
主要终点
PTSD symptom severity

研究概览

简要总结

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 it's still unclear what the clinical relevance of this differentiation is. In addiction care approximately one out of three patients suffer from (C)PTSD. It's unclear if in patients with a substance use disorder (SUD) comorbid CPTSD results in poorer treatment outcomes compared to comorbid PTSD.

详细描述

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 it's still unclear what the clinical relevance of this differentiation is. In addiction care approximately one out of three patients suffer from (C)PTSD. It's 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 1:1) 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).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥18 years. •- Primary diagnosis SUD involving one of the following substances: alcohol, cannabis, cocaine, amphetamine, benzodiazepine, opioid according to the DSM-5 (American Psychiatric Association, 2013), who are receiving or starting outpatient CRA.
  • A DSM-5 diagnosis of PTSD (n=25). A DSM-5 diagnosis of PTSD and an additional ICD-11 diagnosis of CPTSD (n=25).
  • Planned start of EMDR-therapy within 8 weeks.
  • Good Dutch language proficiency (based on clinical judgement).
  • Written informed consent

排除标准

  • 未提供

结局指标

主要结局

PTSD symptom severity

时间窗: September 2023- September 2025

Changes over time in PTSD symptom severity between participants with comorbid PTSD and CPTSD from T0-T2 as measured by the PCL-5.

Proportion of lost of the (C)PTSD diagnosis

时间窗: September 2023- September 2025

Proportion loss of (C)PTSD diagnoses in EMDR completers (as determined by their therapists) in both groups at end of treatment (T2) as measured by the ITQ and CAPS-5.

次要结局

  • substance use severity(September 2023- September 2025)

研究者

发起方
IrisZorg
申办方类型
Other
责任方
Sponsor

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