A Feasibility Study of Internet Delivered Prolonged Exposure for Patients Wit Post-traumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of drop-outs from treatment
研究概览
简要总结
The primary objective with this study is to investigate the feasibility and acceptability of ten weeks of internet delivered prolonged exposure delivered through a digital platform with therapist support. The secondary objective is to investigate preliminary effects of internet delivered prolonged exposure in terms of reducing symptoms of post-traumatic stress, depression and increase quality of life.
详细描述
The investigators will investigate internet delivered prolonged exposure delivered as a ten-week treatment comprising of six modules (psychoeducation/rational, in vivo exposure, imaginal exposure, common problems during exposure, hot spots and relapse prevention). 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. Recruitment is designed to be broadly inclusive with minimal exclusion criteria. Patients will be recruited from a psychiatric clinic specialized in PTSD in Stockholm, Sweden and by advertisements in newspapers and social media.
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
- •Currently primary diagnosis PTSD according to DSM-5 diagnostic criteria for PTSD
- •≥ 18 years
- •Fluent in Swedish
- •Signed informed consent
排除标准
- •PTSD is not the primary concern
- •Initiation or adjustment of any psychotropic medication within the last 4 weeks prior to commencement of treatment
- •Ongoing substance dependence
- •Current suicide risk meriting crisis intervention
- •Psychotic disorder
- •Ongoing trauma-focused psychological treatment
- •Ongoing trauma-related threat (e.g. living with a violent spouse)
结局指标
主要结局
Number of drop-outs from treatment
时间窗: Completion of the treatment period, up to 10 weeks
Treatment acceptability
Number of in vivo exposures made by the participant during the treatment period
时间窗: Through the treatment period, up to 10 weeks
Number of in vivo exposures made by the participant during the treatment period
Adverse events related to the treatment
时间窗: Through study completion, up to the 6 months follow up
Treatment acceptability
Number of imaginal exposures made by the participant during the treatment period
时间窗: Through the treatment period, up to 10 weeks
Number of imaginal exposures made by the participant during the treatment
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]
The proportion of participants that conducts the weekly measures and further assessment points
Participants experience/satisfaction with treatment and assessment procedures through qualitative interviews
时间窗: Completion of the treatment period up to the 6-month follow up
Qualitative interviews
Participants satisfaction with treatment, assessed by The Client Satisfaction Questionnaire (CSQ-8).
时间窗: Completion of the treatment period, up to 10 weeks
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.
The proportion of participants that go through the entire treatment period
时间窗: Completion of the treatment period, ten weeks
The proportion of participants that go through the entire treatment period
次要结局
- Change in PTSD symptoms as assessed by the Clinician Administered PTSD Scale (CAPS-5)(Baseline, 1 month and 6 months follow up)
- Change in ICD-11 PTSD and complex PTSD symptoms as assessed by the International Trauma Questionnaire (ITQ).(Baseline, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
- Change in depressive symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9)(Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
- Change in PTSD symptoms as assessed by the PTSD Check List - DSM-5 (PCL-5)(Baseline, weekly through 10 weeks of treatment, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
- Change in quality of life measured by Euroqol, EQ-5D(Baseline, post-treatment (immediately after treatment completion at 10 weeks), and the 1 month and 6 months follow up.)
研究者
Maria Bragesjo
Principal investigator
Karolinska Institutet