How Effective and Safe is Trauma Therapy Using Prolonged Exposure for Patients With PTSD and a Comorbid Psychotic Disorder? Treatment Trauma and Psychosis -TEP
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Remission of PTSD diagnosis
研究概览
简要总结
Psychosis patients with comorbid PTSD will be treated with trauma therapy.
详细描述
This is a monocentric, controlled, prospective, randomised trial. (RCT). The study population is outpatients with psychotic illness and comorbid post-traumatic stress disorder who have applied for outpatient psychotherapy at the psychotherapeutic outpatient clinic (HSA) of the Medical School Hamburg. It will be investigated whether trauma therapy (Prolonged Exposure) reduces PTSD and psychosis symptoms in comparison to the waiting group. The study will be conducted from 01.09.2023 to 30.04.2028. Patients with suitable symptoms should be seen in the psychotherapeutic outpatient (psychotherapeutic consultation hours) at the HSA should be made aware of the study.
In the next step, a detailed diagnosis is made and, if consent is given and the inclusion criteria listed below are met, the patients are enrolled in the study.
The sample size for the longitudinal intent-to-treat (ITT) analysis with a linear mixed model (LMM) was chosen. Models (LMM) was calculated based on a previous RCT (Van den Berg et al., 2016, effect size for PE in CAPS versus waitlist (TAU) d = 0.78, p < 0.001; effect size for PE in paranoia versus waitlist (TAU) d = 0.62, p = .005). ITT analyses with LLM are relatively robust to missing data, despite which we calculate a 20% dropout rate. With an alpha of 0.05; a mean effect size of 0.5, 3 measurement replicates (baseline measurement T0, post-treatment T1, 6-month follow-up after post, T2), we require 28 patients per treatment arm. A total of 56 patients will be included in the study.
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 (Participant)
盲法说明
Treatment as usual group compared to intervention group.
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
- •Presence of a psychotic disorder (F20) or affective disorder with psychotic symptoms(F30) according to DSM-
- •comorbid post-traumatic stress disorder (PTSD) according to DSM-5 (CAPS-5 score ≥ 23)
- •At least 18 years old
- •Good knowledge of the German language
- •Willingness to participate in randomisation and trauma-focused therapy
排除标准
- •Changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects).
- •Any substance dependence with continued use other than nicotine and/or caffeine dependence.
- •IQ of 70 or less
- •Acute suicidality
- •Pregnant women
研究组 & 干预措施
Waiting control group
The patients in the treatment-as-usual control group remain on the waiting list for 14 weeks after the baseline measurement. After 14 weeks, they participate in the study diagnostics post-treatment at time point.
Intervention group
In the intervention condition, patients are treated directly after the baseline measurement by Prolonged Exposure in 16 hours of individual therapy. The 16 individual therapy sessions will take place in 1 to 2 sessions per week over a period of 7 to 16 weeks. The individual therapy sessions are videotaped with camera focus on the therapist. Parts of the Prolonged Exposure process (the re-experiencing of the traumatic memory) are recorded on tape, so that the patient can listen to the recording as homework at home. Afterwards, the patients take part in a study diagnostic session.
干预措施: Prolonged Exposure (Behavioral)
结局指标
主要结局
Remission of PTSD diagnosis
时间窗: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD diagnosis (cut-off score lower than 23)
severity of PTSD symptoms
时间窗: baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months)
Clinical-Administered PTSD Scale for DSM-5 (CAPS, Blake etal., 1998), presence of PTSD and score for severity of PTSD symptoms
次要结局
- subjective PTSD symptoms(baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months))
- Wellbeing(baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months))
- severity of psychosis(baseline (pre-intervention), post-intervention (after 16 psychotherapy sessions or for waiting group after 4 months) and follow-up (after 6 months))