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

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.

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.

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