Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
研究概览
简要总结
The research aims to assess the practicality and implementation aspects, effectiveness, and processes of change related to Condensed Internet-delivered Prolonged Exposure (CIPE) administered as an early trauma focused intervention after sexual assault. Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa, Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that.
详细描述
The study is un-controlled with 30 participants that will undergo a brief trauma-focused Internet-based CBT treatment, delivered as a three-week treatment comprising of four modules (psychoeducation/rational, in vivo exposure, imaginal exposure and relapse prevention). The primary outcome is level of symptoms of post traumatic stress rated by the PCL-5. Secondary outcomes are level of symptoms of post traumatic stress using the Clinician Administered PTSD Scale version 5 (CAPS-5) and The International Trauma Questionnaire (ITQ), level of depression (PHQ-9), quality of life (WSAS and EQ-5D ) dropout rate, rates of inclusion, attrition, adherence,and negative effects.
Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants' views on the treatment, preferences for this type of treatment and how to further improve it.
The treatment effects will be evaluated using a within-group design with repeated measurements. Participants in the study will be will recruited from patients treated for sexual assault at Traumamottagning Centrum för Sexuell Hälsa, Malmö.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Experienced trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).
- •At least mild clinical symptoms assessed using the PCL-5 cut-off >10
- •≥ 18 years
- •Signed informed consent
排除标准
- •Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk)
- •Unable to read and write in Swedish
- •Receiving other psychological trauma-focused treatment
- •Ongoing trauma-related threat (e.g., living with a violent spouse)
- •Not stable dose of antidepressant medication the last two weeks
结局指标
主要结局
Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)
时间窗: Baseline, weekly through three weeks of treatment, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.
The PCL-5 is a 20-item self-report measure based upon the Diagnostic and Statistical Manual (DSM-5) criteria for PTSD. Total Score (Range 0-80 with higher scores representing more PTSD symptoms.
次要结局
- Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.)
- Change in psychosocial impairment measured by The Work and Social Adjustment Scale (WSAS), adapted to symptoms of post-traumatic stress.(Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.)
- Clinician Administered PTSD Scale version 5 (CAPS-5), the gold standard clinical interview to assess PTSD symptom severity and diagnosis of PTSD(Three months after treatment completion.)
- The International Trauma Questionnaire (ITQ)(Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.)
- Change in drug use measured by Drug Use Disorders Identification Test (DUDIT)(Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.)
- Change in quality of life measured by EQ-5D(Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.)
- Change in use of alcohol measured by Alcohol Use Disorders Identification Test (AUDIT)(Baseline, post-treatment (immediately after treatment completion at three weeks), and the 1 month, 3 month, 6 month and 12 month follow up.)
研究者
Maria Bragesjo
Princicpal investigator, PhD
Karolinska Institutet