A Feasibility Study of Intensive Treatment With Prolonged Exposure for Patients With Post-traumatic Stress Disorder (PTSD) in a Regular Health Care Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- The proportion of participants that go through the entire treatment period
研究概览
简要总结
The primary objective with this study is to investigate the feasibility and acceptability of intensive treatment with prolonged exposure (I-PE) in regular Swedish psychiatric care. The secondary objective is to investigate preliminary effects of i-PE in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.
详细描述
The investigators will investigate I-PE delivered as a one-week intensive treatment consisting of nine individual sessions and five group sessions followed by three individual session two, four and eight weeks afterwards in a pilot trial. The feasibility and acceptability and preliminary effects of treatment- and assessment procedures will be evaluated using a within-group design with repeated measurements and qualitative interviews. The individual sessions will consist of imaginal exposure and processing and the group sessions of psychoeducation, rationale for treatment and in vivo exposure work. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialised in PTSD in Stockholm, Sweden.
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
- •Meet criteria for PTSD
- •If taking psychotropic medication, then the dose must be stable for at least 4 weeks prior to study entry
- •≥ 18 years
- •Fluent in Swedish
- •Signed informed consent
排除标准
- •Other serious comorbidity as primary concern (for example ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, high suicidal risk)
- •Other ongoing trauma-focused psychological treatment
- •Ongoing trauma-related threat (e.g. living with a violent spouse)
研究组 & 干预措施
Intensive treatment with prolonged exposure
Intensive treatment with prolonged exposure
干预措施: Intensive treatment with prolonged exposure (Behavioral)
结局指标
主要结局
The proportion of participants that go through the entire treatment period
时间窗: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Number of imaginal exposures made by the participant during the treatment period
时间窗: Through treatment, up to the last session delivered eight weeks after the massed treatment week
Number of individuals offered the intervention but declined part of treatment
时间窗: Baseline
Treatment acceptability
Number of in vivo exposures made by the participant during the treatment period
时间窗: Through treatment, up to up to the last session delivered eight weeks after the massed treatment week
The proportion of participants that conducts the weekly measures and further assessment points
时间窗: Through study completion up to the 6 months follow up
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
时间窗: Completion of the massed treatment period (one week)
The CSQ-8 yields a single score measuring a single dimension of overall satisfaction. An "overall score" is calculated by summing the score on each of the eight scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction.
Adverse events related to the treatment
时间窗: Through study completion, up to the 6 months follow up
Treatment acceptability
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
时间窗: Completion of the massed treatment period up to post-treatment
Qualitative interviews
Number of drop-outs from treatment
时间窗: Completion of treatment period, up to the last session delivered eight weeks after the massed treatment week
Treatment acceptability
次要结局
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)(Pre-treatment, 6 months follow up)
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)(Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
- Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).(Baseline, daily through the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
- Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
- Change in quality of life measured by Euroqol, EQ-5D(Baseline, last 1 day of the treatment 1 week, at the 2, 4 and 8 week sessions and the 6 months follow up.)
研究者
Maria Bragesjo
Principal investigator
Karolinska Institutet