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Evaluation of Restory - an Online Trauma Treatment for Victims of Sexual Abuse (Restory)

2026年8月4日 更新者:Malin Joleby、Karolinska Institutet

A Randomised Waitlist Controlled Clinical Trial of the Restory Trauma Treatment Program

This project aims to evaluate Restory - a newly developed anonymous, iCBT prolonged exposure therapy program specifically tailored for victims of sexual abuse - using a pre-registered randomized controlled trial with waitlist control. The primary research question is whether Restory is more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5.

研究概览

地位

招聘中

干预/治疗

详细说明

Restory has been developed to address the current lack of available, low-threshold treatment for sexual abuse victims. Restory is a free, anonymous, trauma-focused, iCBT program. iCBT has been shown to be as effective as face-to-face treatment for several conditions. iCBT for PTSD has documented efficacy, regardless of the patient's age, and even intensive formats have proven feasible despite concerns about increased risk of dropout or symptom deterioration. There are indications that internet-based treatment can even enhance the patient's sense of self-efficacy since they are encouraged to take on a more active role in their treatment, which is particularly beneficial for individuals with PTSD facing negative self-cognitions.

A recent review of barriers to formal help-seeking following sexual victimization concluded that increasing resource availability and access is crucial. iCBT can thus play a pivotal role in breaking down barriers by providing nationwide access to care, regardless of geographical location, thus democratizing access to specialized care for an underserved patient population. By offering treatment anonymously, we believe we can further promote help-seeking by mitigating the stigma, guilt shame, and confidentiality concerns that often hinder victims of sexual abuse from seeking care. This is valuable for the patient group at large, but particularly beneficial for victim groups that are less likely to seek help, including minority groups (racial, ethnical, and sexual minorities), boys and men, victims of female offenders, and victims of technology-assisted sexual abuse as they may face heightened risk of experiencing shame, stigma, and cultural and social barriers. iCBT treatment can be conducted discreetly and flexibly online, accommodating the patient's schedule without the need for physical clinic visits, thereby reducing the risk of recognition. Overall, this approach aligns with the objective outlined by the Swedish Association of Local Authorities and Regions to ensure equitable care nationwide and to better address the needs of particularly vulnerable groups.

An important aspect of Restory, and a gap it aims to fill, is that it is a treatment program specifically designed for a unique patient group: victims of sexual abuse. This is crucial because sexual victimization is often associated with fear, anxiety, and shame, making the quality of the therapeutic encounter essential. The lack of specialized clinics means that victims of sexual abuse are often left to seek care through a regular medical center or emergency room, where the medical staff do not have any specific training in meeting this patient group. Research has indicated that women disclosing to both informal and formal supports reported more negative (e.g. victim blaming and disbelief) than positive reactions. These negative reactions have in turn been linked to adverse outcomes such as PTSD, depression, psychological and physical distress, and maladaptive coping. Hence, it is imperative that specialized care is provided by knowledgeable staff, and ideally with a treatment program specifically tailored to the unique needs of the patient group.

The project implements Public and Patient Involvement (PPI) from start to finish of the project. Experts from organisations working with this patient, and a patient representative with lived experience of sexual abuse, are part of an Advisory Board providing feedback on the planning of the studies and in the development of the treatment program.

The target population is adult victims of sexual abuse suffering from post-traumatic stress disorder. Interested individuals will self-refer and register via the study platform (www.restorystudien.se).

A Project Plan and a Statistical Analysis Plan (SAP) was pre-registered at the OSF platform (https://osf.io/mxf7t/overview) before recruitment commenced.

研究类型

介入性

注册 (估计的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Stockholm、瑞典、11364
        • 招聘中
        • Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
        • 接触:
        • 首席研究员:
          • Malin Joleby, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • 18+ years
  • exposure to sexual violence where a minimum of 1 month has passed since the incident
  • self-reported total PCL-5 of minimum 30
  • current stable dose of psychotropic medication (for at least 4 weeks) or medication free
  • sufficient Swedish skills
  • willingness and availability to participate

Exclusion Criteria:

  • Ongoing trauma-related threat (e.g. living with a violent spouse)
  • severe psychiatric illness requiring immediate alternative treatment (such as high acute suicide risk or presence of psychotic episode, assessed during screening interview)
  • current participation in other trauma-focused CBT or Eye Movement Desensitization and Reprocessing therapy
  • current benzodiazepine treatment
  • no trauma memory

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Restory
A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse
Restory contains eight modules over eight weeks, and is a cognitive behavioral therapy program based on prolonged exposure (PE), specifically tailored for victims of sexual abuse. The program comprises all core treatment elements in PE (Foa et al., 2021), together with added psychoeducation on aspects specifically relevant for this patient group (i.e. shame, guilt, disgust, sexuality). Each module contains psychoeducational text, a description of the how the treatment works, and instructions for homework assignments. After completing a module and receiving personalized feedback from the therapist, the participant proceeds to the next module.
无干预:Waitlist
The waitlist control group will wait a minimum of nine weeks before starting active treatment (Restory). During the waitlist period, the participant will be followed up, responding to the same set of questionnaires as participants in the treatment group.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
PTSD symptom severity score, as measured by PCL-5
大体时间:From baseline to end of treatment at 8 weeks
Is Restory more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.
From baseline to end of treatment at 8 weeks

次要结果测量

结果测量
措施说明
大体时间
PTSD symptom severity score, as measured by the PTSD-part of the ITQ
大体时间:From baseline to end of treatment at 8 weeks
Is Restory more effective than a waitlist control in reducing PTSD symptom severity score, as measured by the PTSD-part of the ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
From baseline to end of treatment at 8 weeks
Complex-PTSD symptom severity score, as measured by the Disturbances in Self-Organization part of ITQ?
大体时间:From baseline to end of treatment at 8 weeks
Is Restory more effective than a waitlist control in reducing Complex-PTSD symptom severity score, as measured by the Disturbances in Self-Organization part of ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
From baseline to end of treatment at 8 weeks
Depressive symptoms, as measured by MADRS-S
大体时间:From baseline to end of treatment at 8 weeks
Is Restory more effective than a waitlist control in reducing depressive symptoms, as measured by MADRS-S (Montgomery Åsberg Depression Rating Scale)? Scores range from 0 to 54, with higher scores indicating greater symptom severity.
From baseline to end of treatment at 8 weeks
PTSD symptom severity score, as measured by the PCL-5 at 1- and 6-month follow-up
大体时间:From post treatment to 1-month and 6-month follow-up
Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for PTSD symptom severity score, as measured by the PCL-5 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.
From post treatment to 1-month and 6-month follow-up
PTSD symptom severity score, as measured by the PTSD-part of the ITQ, at 1-month and 6-month follow-up
大体时间:From post treatment to 1-month and 6-month follow-up
Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for PTSD symptom severity score, as measured by the PTSD-part of the ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
From post treatment to 1-month and 6-month follow-up
Complex-PTSD symptom severity score, as measured by the Disturbances in Self- Organization part of ITQ at 1-month and 6-month follow-up
大体时间:Post treatment to 1-month and 6-month follow-up
Are treatment gains from Restory maintained or improved at 1-month follow-up and 6-month follow up for Complex-PTSD symptom severity score, as measured by the Disturbances in Self- Organization part of ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
Post treatment to 1-month and 6-month follow-up
Depressive symptoms, as measured by MADRS-S at 1-month and 6-month follow-up
大体时间:From after treatment to 1-month and 6-month follow-up
Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for depressive symptoms, as measured by MADRS-S (Montgomery Åsberg Depression Rating Scale)? Scores range from 0 to 54, with higher scores indicating greater symptom severity.
From after treatment to 1-month and 6-month follow-up

其他结果措施

结果测量
措施说明
大体时间
Quality of life, measured with the AQoL-8D
大体时间:From baseline to end of treatment at 8 weeks
Is Restory more effective than a waitlist control in increasing quality of life, measured with the AQoL-8D (Assessment of Quality of Life - 8 Dimensions)? The AQoL-8D has 35 items and eight dimensions. Items have different response levels, each representing increasing levels of severity.
From baseline to end of treatment at 8 weeks
Trauma-related shame, measured with the TRSI-24
大体时间:From baseline to end of treatment at 8 weeks
Is Restory more effective than a waitlist control in reducing trauma-related shame, measured with the TRSI-24 (Trauma-Related Shame Inventory)? Scores range from 0 to 72, with higher scores indicating greater trauma-related shame.
From baseline to end of treatment at 8 weeks
Negative post-traumatic cognitions, measured with the PTCI-9
大体时间:From baseline to end of treatment at 8 weeks
Is Restory more effective than a waitlist control in reducing negative post-traumatic cognitions, measured with the PTCI-9 (Posttraumatic Cognitions Inventory)? Scores range from 9 to 63, with higher scores indicating more negative trauma-related cognitions.
From baseline to end of treatment at 8 weeks
Quality of life, measured with the AQoL-8D at 1-month and 6-month follow-up
大体时间:From after treatment to 1-month and 6-month follow-up
Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for quality of life, measured with the AQoL-8D (Assessment of Quality of Life - 8 Dimensions)? The AQoL-8D has 35 items and eight dimensions. Items have different response levels, each representing increasing levels of severity.
From after treatment to 1-month and 6-month follow-up
Trauma-related shame, measured with the TRSI-24 at 1-month and 6-month follow-up
大体时间:From after treatment to 1-month and 6-month follow-up
Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for trauma-related shame, measured with the TRSI-24 (Trauma-Related Shame Inventory)? Scores range from 0 to 72, with higher scores indicating greater trauma-related shame.
From after treatment to 1-month and 6-month follow-up
Negative post-traumatic cognitions, measured with the PTCI-9 at 1-month and 6-month follow-up
大体时间:From after treatment to 1-month and 6-month follow-up
Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for negative post-traumatic cognitions, measured with the PTCI-9 (Posttraumatic Cognitions Inventory)? Scores range from 9 to 63, with higher scores indicating more negative trauma-related cognitions.
From after treatment to 1-month and 6-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月4日

初级完成 (估计的)

2027年5月4日

研究完成 (估计的)

2027年11月4日

研究注册日期

首次提交

2026年5月20日

首先提交符合 QC 标准的

2026年5月20日

首次发布 (实际的)

2026年5月27日

研究记录更新

最后更新发布 (实际的)

2026年8月7日

上次提交的符合 QC 标准的更新

2026年8月4日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • Dnr 2025-08612-01
  • 2024-116 (其他赠款/资助编号:Fredrik och Ingrid Thurings stiftelse)
  • 04904/2024 (其他赠款/资助编号:Brottsofferfonden)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Anonymized data will be uploaded to a repository managed by Karolinska Institutet.

IPD 共享时间框架

Data will become available maximum three months after publication and remain available for an indefinite amount of time.

IPD 共享访问标准

Investigators who provide a methodologically sound proposal, and whose proposed use of the data has been approved by an independent review committee identified for this purpose. Any researcher may access the version of the data available in a public repository.

For what types of analyses? To achieve aims in the approved proposal and for meta-analysis

By what mechanism will data be made available? Proposals should be directed to the Data Access Unit at Karolinska Institutet.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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