Patient Engagement in PTSD Treatment (PEP) - Advancing PTSD Treatment Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 427
- 试验地点
- 1
- 主要终点
- International Trauma Questionnaire (ITQ)
研究概览
简要总结
The goal of this clinical study is to improve the outcome of outpatient PTSD treatment at two clinics treating majority ethnic Danes and refugees with PTSD respectively. The study will consist of two similar randomized controlled trials.
The main questions the study aims to answer are:
- Does an added motivation enhancement module as a precursor for PTSD treatment reduce dropout and increase treatment outcome?
- Does an added Shared Decision-Making session which facilitate individualized treatment yield a superior outcome compared to PTSD treatment and PTSD treatment supplemented by motivation enhancement?
Participants are recruited at two different clinics, Psychotherapeutic Unit (PU) and Competence Centre for Transcultural Psychiatry (CTP). At PU the participants are randomized to one of two arms, and at CTP to one of three arms. One arm is the control group where participants will receive treatment as usual (TAU), one arm is the first intervention group where the participants will receive an Introductory PTSD module consisting of four sessions focusing on enhancing motivation for PTSD treatment, before continuing in TAU. The last arm is the second intervention group, which will only take place at CTP. Here the patient will receive the Introductory PTSD module followed by a session of Shared Decision Making, where the participant together with the MD decides which of four standardized treatment courses they will receive.
The treatment for all patients will last between 8-13 months.
详细描述
INTRODUCTION Traumatic events are a common experience worldwide. Data from the World Mental Health Consortium indicate that 70% of the general population reports at least one traumatic event, with 30.5% reporting four or more events. Certain populations, such as refugees and individuals in trauma-exposed professions (e.g., police officers, paramedics, and military personnel), are at heightened risk of encountering traumatic experiences. While the majority of individuals exposed to trauma do not develop long-term psychological distress, a significant subset develops posttraumatic stress disorder (PTSD), the primary mental health condition associated with trauma. According to the 2017 WHO World Mental Health Survey, 5.6% of trauma-exposed individuals develop PTSD, with half of these cases being persistent. PTSD is among the leading health-related causes of functional impairment, including days out of role.
Despite existing evidence-based interventions for PTSD, one-third of those undergoing treatment are non-responders and one-third drop out. This poses significant economic and social costs to the patient and to society. Previous randomized trials on refugees with PTSD at the CTP have pointed to motivation and cognitive resources as key predictors of treatment outcome. Others have theorized, and shown, that using standardized shared decision-making tools can enhance patient engagement in evidence-based PTSD treatment. Understanding the prerequisites of patients, such as motivational readiness and cognitive resources, are important in guiding decisions about treatment. At best, assigning homework or providing ambitious psychoeducation is a vain effort if the patient does not possess the motivation or cognitive means to engage, comply or fully understand. At worst, it demotivates and adds to the patient's sense of inadequacy.
These theories and hypotheses point to the need to gauge motivation, patient preference and values and assess cognition at the outset of treatment properly and to assess how to adapt treatment to fit each patient individually.
The overall aim of the PEP study is to improve the outcome of outpatient PTSD treatment.
- To test the added value of the introductory PTSD module as a precursor of PTSD treatment in two RCTs. It is hypothesized that promoting patient engagement and motivation for treatment will increase treatment outcomes and reduce dropout relative to TAU.
- To test the value of SDM to facilitate individualized treatment for the diverse population of refugees. This aim is specific to the CTP-trial. It is hypothesized that SDM + IPM will yield a superior outcome to TAU + IPM based on optimal utilization of resources of patients and clinicians.
- To compare cognitive deficits in Danish civilians and trauma-affected refugees with PTSD, examining influences of emotional distress, demographic and socio-economic factors on test performance and to determine the predictive value of cognitive tests on treatment outcomes.
- To study the association between motivation and severity of mental health symptoms, quality of life and functioning at baseline
- To explore what patients and clinicians find useful and valuable about the introductory PTSD module add-on and SDM, and determine how these two components can influence treatment readiness and patient engagement
- To examine the effect of treatment at six months follow-up on overall PTSD symptoms Course of treatment and data collection will follow the SPIRIT statement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •of the randomised controlled trial for Psychotherapeutic Unit
- •Inclusion Criteria:
- •Adults (18 years or older)
- •PTSD pursuant to the ICD-10 research criteria
- •Signed informed consent
- •patients referred to "Main Level" treatment
- •Exclusion Criteria:
- •Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
- •Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).
- •In- and exclusion criteria of the randomised controlled trial for Competencecenter of Transcultural Psychiatry:
- •Inclusion criteria:
- •Adult (18 years or older)
- •Refugees or persons who have been family reunified with a refugee
- •PTSD pursuant to the ICD-10 research criteria
- •Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nations' definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
- •Signed informed consent
- •Exclusion criteria:
- •Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Participants are excluded only if the psychotic experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
- •Dependence syndrome of drugs or alcohol: Active dependence and use (F1x.24-F1x.26).
研究组 & 干预措施
Introductory PTSD module + TAU
9-13 months of treatment An intervention with an introductory PTSD module consistent of four sessions focusing on motivation followed by TAU
干预措施: Introductory PTSD module (Behavioral)
Introductory PTSD module + TAU
9-13 months of treatment An intervention with an introductory PTSD module consistent of four sessions focusing on motivation followed by TAU
干预措施: Treatment as Usual (Behavioral)
Treatment as usual (TAU)
8-12 months of treatment Interventions: Behavioral: treamtent as usual (TAU)
干预措施: Treatment as Usual (Behavioral)
Introductory PTSD module + one session of Shared Decision Making + individualised treatment
9-13 months of treatment Add-on introductory PTSD module and add-on patient-centred shared decision making session before continuing in the chosen standardised treatment.
干预措施: Introductory PTSD module (Behavioral)
Introductory PTSD module + one session of Shared Decision Making + individualised treatment
9-13 months of treatment Add-on introductory PTSD module and add-on patient-centred shared decision making session before continuing in the chosen standardised treatment.
干预措施: Shared Decision Making (Behavioral)
Introductory PTSD module + one session of Shared Decision Making + individualised treatment
9-13 months of treatment Add-on introductory PTSD module and add-on patient-centred shared decision making session before continuing in the chosen standardised treatment.
干预措施: Standardised treatments (Behavioral)
结局指标
主要结局
International Trauma Questionnaire (ITQ)
时间窗: Change from baseline to end-of-treatment after approximately 10 months
A brief, simply worded measure, focusing only on the core features of PTSD and CPTSD, and employs straightforward diagnostic rules, based on the International Classification of Diseases, 11th edition (ICD-11). Scoring range: 0-4, lower scores reflect better outcome
次要结局
- Patient satisfaction survey(Administered once at the end of treatment)
- International Trauma Interview (ITI)(Administered only at the initial assessment)
- Readiness of Psychotherapy Index (RPI)(Change from baseline to after intervention after approximately 1,5 months)
- Hopkins Symptom Check List-25 (HSCL)(Change from baseline to end-of-treatment after approximately 10 months)
- Psychological Outcome Profiles questionnaire (PSYCHLOPS)(Change from baseline to end-of-treatment after approximately 10 months)
- World Health Organisation - 5 Well-being Index (WHO-5)(Change from baseline to end-of-treatment after approximately 10 months)
- Life Events Checklist for DSM-5 (LEC-5)(Administered once at the initial assessment)
- Post-migration Living Difficulties Check List (PMLD)(Administered once at the initial assessment, but only at CTP)
- The 9-item Shared Decision Making questionnaire (SDM-Q-9)(Administered once during treatment at the shared decision-making session only at CTP)
- The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)(Change from baseline to end-of-treatment after approximately 10 months)
- The World Health Organization Disability Assessment Schedule (WHODAS 2.0), cognition(Change from baseline to end-of-treatment after approximately 10 months)
- Hamilton depression scale (HAM-D6)(Change from baseline to end-of-treatment after approximately 10 months)
- Global Assessment of Functioning - Symptoms (GAF-S)(Time Frame: Change from baseline to end-of-treatment after approximately 10 months)
- Global Assessment of Functioning - Functioning (GAF-F)(Change from baseline to end-of-treatment after approximately 10 months)
- Shared Decision Making questionnaire - physician version (SDM-Q-Doc)(Administered once during treatment at the shared decision-making session only at CTP)
研究者
Anna Bolette Lund Nielsen
MD
Herlev and Gentofte Hospital