The Key to Integrated Trauma Treatment in Psychosis (Kit) Trial: A Pragmatic, Multicenter Effectiveness RCT of EMDR for Trauma Symptoms in Schizophrenia Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 187
- 试验地点
- 13
- 主要终点
- Trauma symptoms
研究概览
简要总结
Schizophrenia spectrum disorders (SSDs) have a significant trauma etiology: trauma has been reported in 65 - 80% in this patient group and have a negative impact on prognosis. Trauma treatment is currently not offered in SSDs due to a lack of evidence. KIT is a pragmatic trial comparing the effectiveness of added trauma focused therapy, Eye Movement Desensitization and Reprocessing (EMDR) to standard treatment in SSDs.
The study will compare EMDR as add on to treatment as usual (TAU) to TAU in patients with schizophrenia spectrum disorders (SSDs). The overall aim is to examine the effectiveness of EMDR on trauma symptoms in SSDs.
Participants will receive max. 26 sessions of EMDR, and complete assessments before, during and after the course of therapy, in addition to a period of time (6 months) after therapy to examine long-term effects.
详细描述
The KIT trial is a pragmatic, assessor-blinded, parallel 2-group, superiority randomized trial comparing the addition of EMDR to treatment as usual (TAU) versus waiting list (WL) and TAU for EMDR on symptoms of trauma in patients with SSDs. Participants will be randomized (1:1, block randomization by center and gender) to one of the two groups.
Aims, hypotheses, objectives:
- The primary aim is to investigate the effectiveness of EMDR as an add-on treatment for SSDs in standard clinical practice to target trauma symptoms.
- The secondary aim is to improve personalized therapy through the exploration of clinical stratification variables that may influence the effectiveness of EMDR.
- The long-term aim is to guide clinical practice and, if shown to be effective, to implement EMDR for patients with SSDs.
- The primary objective: EMDR and treatment as usual (TAU) compared to waiting list (WL) and TAU will reduce symptoms of trauma as measured by the ITQ (the International Trauma Questionnaire) in SSDs.
- The secondary objective: Stratification variables (trauma profile e.g. type, severity, timing; gender; biomarkers of stress and immune system reactivity; digital biomarkers of autonomous stress reactivity) influence the effectiveness of EMDR.
Expected results during the project period:
- The EMDR group will show less trauma symptoms compared to the WL control group by the end of treatment and possibly better functioning.
- No differences for costs nor serious adverse events will emerge between the groups at the end of treatment.
- Better outcomes are expected for trauma characterized by mild to moderate severity and later onset (e.g. related to experience of psychosis) as compared to CT (e.g. abuse and neglect).
- Although exploratory, patients with high levels of inflammation markers and/or hyperarousal and autonomous reactivity to trauma benefit most from EMDR.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥ 16 years
- •diagnosis of F20-29 in the ICD-10 assessed using SCID 5 CV
- •reporting trauma > 1 month prior to assessment
- •being currently distressed by the reported trauma(s), i.e., ≥ 5 (from 0 = not at all, to 10 = extremely) on item 21c on the Trauma and Life Events Checklist (TALE)
- •able and motivated for engaging in trauma focused (TF) therapy
- •able to understand and give informed consent; consent capacity for psychological treatment choices and consent to study procedures.
排除标准
- •primary diagnosis of substance use/alcohol dependence
- •inability to understand spoken Norwegian
- •organic psychosis or a neurological disorder
- •acute state of psychosis defined as:
- •hospitalized in an acute ward the last 6 weeks or
- •major change in antipsychotic medication type or started/stopped antipsychotic medication last 6 weeks or
- •other mental health crises last 6 weeks
- •current or previous (past 6 months) TF therapy
研究组 & 干预措施
Trauma-focused therapy: EMDR for psychosis and treatment as usual (TAU)
Patients randomized to receive max. 26 sessions of EMDR for psychosis.
干预措施: Eye Movement Desensitization and Reprocessing (EMDR) for psychosis (Other)
Treatment as usual (TAU) and waiting list (WL)
Patients randomized to continue with treatment as usual (TAU) for 6 months as a waiting list (WL) control group. TAU consists of an individual combination of treatments for SSDs in line with Norwegian national guideline (e.g. medication, cognitive therapy, work training, music therapy).
结局指标
主要结局
Trauma symptoms
时间窗: From baseline to end of treatment at 6 months.
Primary outcome is trauma symptoms as measured by the International Trauma Questionnaire. PTSD symptom scale range from 0 to 24. Higher scores indicate more sever trauma symptoms.
次要结局
- Severity of psychosis symptoms(From baseline to end of treatment at 6 months.)
- The rate of autonomic arousal during trauma processing(Baseline to end of treatment at 6 months.)
- Inflammation(Baseline and end of treatment at 6 months)
研究者
Else-Marie Løberg
Principal Investigator (Professor, PhD, Psychologist)
Haukeland University Hospital