Effectiveness of a Trauma-Focused Group Intervention Within a Collaborative Stepped-Care Model in Primary Care: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in post-traumatic stress symptom severity
研究概览
简要总结
Psychological trauma is common and can lead to long-lasting emotional distress, difficulties in daily functioning, and reduced quality of life. Despite the availability of effective psychological treatments, access to trauma-focused interventions in primary care remains limited.
This study will evaluate the effectiveness and feasibility of a trauma-focused group intervention delivered within a collaborative stepped-care model in primary care. Adults with trauma-related symptoms will be randomly assigned to either receive the trauma-focused group intervention or treatment as usual. The intervention integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy and is delivered in a structured group format.
The study hypothesizes that participants receiving the trauma-focused group intervention will show greater improvements in trauma-related symptoms, emotional regulation, psychological distress, functioning, quality of life, and treatment satisfaction than participants receiving treatment as usual. The study will also evaluate implementation outcomes, including acceptability, feasibility, and participant engagement, to determine whether this intervention can improve access to trauma-focused care within the public healthcare system.
详细描述
Psychological trauma is highly prevalent and is associated with substantial psychiatric and physical morbidity, functional impairment, reduced quality of life, and increased healthcare utilization. In primary care, trauma-related disorders are frequently underrecognized because of their heterogeneous clinical presentation, high rates of comorbidity, and organizational barriers that limit access to evidence-based psychological treatments. Although trauma-focused interventions such as Eye Movement Desensitization and Reprocessing (EMDR) are recommended by international clinical guidelines, their implementation in routine primary care remains limited.
To address this gap, this study evaluates a trauma-focused group intervention implemented within a collaborative stepped-care model in primary care. The intervention integrates evidence-informed principles from EMDR and Sensorimotor Psychotherapy within a phased treatment framework emphasizing stabilization, trauma processing, and integration. The group format was selected to improve accessibility, facilitate implementation in routine healthcare settings, and increase the capacity of public mental health services while maintaining a trauma-informed approach.
This is a pragmatic randomized controlled trial conducted in adults presenting with trauma-related symptoms referred from primary care. Participants will be randomly allocated to receive either the trauma-focused group intervention or treatment as usual. Clinical assessments will be performed at baseline, post-intervention, and follow-up to evaluate changes over time.
The primary objective is to determine whether the trauma-focused group intervention is more effective than treatment as usual in reducing trauma-related symptoms. Secondary objectives include evaluating improvements in emotion regulation, psychological distress, functional impairment, quality of life, and treatment satisfaction. The study will also assess implementation outcomes, including feasibility, acceptability, participant engagement, and the potential integration of the intervention within routine primary care services.
This trial is intended to generate clinically relevant and implementation-focused evidence regarding the effectiveness and scalability of a trauma-focused group intervention delivered in real-world primary care. The findings may contribute to improving access to evidence-based trauma treatment and support the development of collaborative stepped-care models within public healthcare systems.
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
- None
盲法说明
Masking is not feasible due to the nature of the psychological group intervention. Participants, therapists, and investigators are aware of treatment allocation. Outcomes are assessed using standardized self-report questionnaires completed by participants at baseline, post-intervention, and follow-up.
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
- •Currently enrolled in the Primary Care Collaborative Program (PCP) of the Sant Andreu Mental Health District.
- •Diagnosis of post-traumatic stress disorder (PTSD) or the presence of symptoms consistent with trauma-related psychopathology, including PTSD, prolonged stress, complex PTSD (CPTSD), relational trauma, or other trauma-related symptoms associated with adverse life experiences.
- •Sufficient proficiency in Spanish or Catalan to understand the intervention and complete the study assessments.
- •Ability and willingness to provide written informed consent.
排除标准
- •Acute psychotic decompensation.
- •Active suicidal ideation requiring immediate and intensive clinical intervention.
- •Unstable problematic substance use.
- •Unstable comorbid severe mental disorder.
- •Significant cognitive impairment or intellectual or physical disability that would interfere with participation in the group intervention or understanding of the study procedures.
研究组 & 干预措施
Trauma-Focused Group Intervention
Participants allocated to this arm will receive the trauma-focused group intervention immediately after baseline assessment. The intervention is delivered within a collaborative stepped-care model in primary care and integrates evidence-informed principles from Eye Movement Desensitization and Reprocessing (EMDR) and Sensorimotor Psychotherapy. Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up.
干预措施: Trauma-Focused Group Intervention (Behavioral)
Treatment as Usual Wait-List Control
Participants allocated to this arm will receive treatment as usual (TAU) during the study period until completion of the primary post-intervention assessment (T1). After completion of the T1 assessment, participants will be offered the trauma-focused group intervention for ethical reasons. Clinical outcomes will be assessed at baseline (T0), post-intervention (T1), and follow-up.
干预措施: Treatment as Usual (TAU) (Other)
结局指标
主要结局
Change in post-traumatic stress symptom severity
时间窗: Baseline (T0) and post-intervention (10 weeks) (T1)
Post-traumatic stress symptom severity will be assessed using the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5), a 20-item self-report questionnaire that measures the severity of DSM-5 post-traumatic stress disorder symptoms across the domains of intrusion, avoidance, negative alterations in cognition and mood, and alterations in arousal and reactivity. Total scores range from 0 to 80, with higher scores indicating greater post-traumatic stress symptom severity.
次要结局
- Change in general psychological distress and functioning(Baseline (T0) and post-intervention (10 weeks) (T1))
- Change in ICD-11 complex post-traumatic stress symptoms(Baseline (T0) and post-intervention (10 weeks) (T1))
- Change in emotion regulation(Baseline (T0) and post-intervention (10 weeks) (T1))
- Maintenance of post-traumatic stress symptom improvement(post-intervention (10 weeks) (T1) and 3-month follow-up (T2))
- Maintenance of general psychological distress(post-intervention (10 weeks) (T1) and 3-month follow-up (T2))
- Maintenance in ICD-11 complex post-traumatic stress symptoms(post-intervention (10 weeks) (T1) and 3-month follow-up (T2))
- Maintenance in emotion regulation(post-intervention (10 weeks) (T1) and 3-month follow-up (T2))
- Treatment satisfaction(post-intervention (10 weeks) (T1))
研究者
Luis Eduardo Estévez Cachafeiro
Clinical Psychologist
University Ramon Llull
