跳至主要内容
临床试验/NCT07610187
NCT07610187招募中不适用

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

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2026年5月4日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
140
试验地点
1
主要终点
PTSD symptom severity score, as measured by PCL-5

研究概览

简要总结

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.

详细描述

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).

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
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

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Restory

Experimental

A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse

干预措施: Restory (Behavioral)

Waitlist

No Intervention

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.

结局指标

主要结局

PTSD symptom severity score, as measured by PCL-5

时间窗: 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.

次要结局

  • PTSD symptom severity score, as measured by the PTSD-part of the ITQ(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?(From baseline to end of treatment at 8 weeks)
  • Depressive symptoms, as measured by MADRS-S(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(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(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(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(From after treatment to 1-month and 6-month follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Malin Joleby

Research Specialist, PhD

Karolinska Institutet

研究点 (1)

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