A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program (Restory)

Internetförmedlad Psykoterapi för Att Behandla Posttraumatiskt Stressyndrom Efter Sexuella övergrepp

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.

Study Overview

• Status: Recruiting
• Conditions: Sexual Abuse; PTSD - Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Restory

Detailed Description

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 (Andersson et al., 2014). iCBT for PTSD has documented efficacy (Lewis et al., 2017; Litz et al., 2007), regardless of the patient's age (Paiva et al., 2024), and even intensive formats have proven feasible despite concerns about increased risk of dropout or symptom deterioration (Bragesjö et al., 2021). There are indications that internet-based treatment can even enhance the patient's sense of self-efficacy (Knaevelsrud et al., 2017) 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.

In a recent review of barriers to formal help-seeking following sexual victimization, Zinzow et al. (2021) 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; Zinzow et al., 2021), boys and men (Donne et al., 2018), victims of female offenders (Jonsson & Svedin, 2019), and victims of technology-assisted sexual abuse (Joleby et al., 2024) 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 (SKR, 2020) 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 (Kennedy & Prock, 2018). 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 (Kennedy & Prock, 2018), 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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Malin Joleby, PhD; Phone Number: +46736971237; Email: malin.joleby@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 11364
    • Recruiting
    • Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
    • Contact: Malin Joleby, PhD; Phone Number: +46736971237; Email: malin.joleby@ki.se
    • Principal Investigator: Malin Joleby, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restory; A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse	Behavioral: Restory; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD symptom severity score, as measured by PCL-5	Is Restory more effective than a waitlist control in reducing PTSD symptom severity score, as measured by PCL-5?	From baseline to end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD symptom severity score, as measured by the PTSD-part of the ITQ	Is Restory more effective than a waitlist control in reducing 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?	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?	From baseline to end of treatment at 8 weeks
Depressive symptoms, as measured by MADRS-S	Is Restory more effective than a waitlist control in reducing 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	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?	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	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?	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	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?	Post treatment to 1-month and 6-month follow-up
Depressive symptoms, as measured by MADRS-S at 1-month an 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?	From after treatment to 1-month and 6-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life, measured with the AQoL-8D	Is Restory more effective than a waitlist control in increasing quality of life, measured with the AQoL-8D?	From baseline to end of treatment and 1-month and 6-month follow-up
Trauma-related shame, measured with the TRSI-24	Is Restory more effective than a waitlist control in reducing trauma-related shame, measured with the TRSI-24?	From baseline to end of treatment and 1-month and 6-month follow-up
Negative post-traumatic cognitions, measured with the PTCI-9	Is Restory more effective than a waitlist control in reducing negative post-traumatic cognitions, measured with the PTCI-9?	From baseline to end of treatment and 1-month and 6-month follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Göteborg University; Linkoeping University

Publications and helpful links

Helpful Links

• Preregistration on osf.io

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2026
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): November 4, 2027

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 20, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Trauma; Online; PTSD treatment; Sexual Abuse; Anonymous
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Combat Disorders
• Other Study ID Numbers: Dnr 2025-08612-01; 2024-116 (Other Grant/Funding Number: Fredrik och Ingrid Thurings stiftelse); 04904/2024 (Other Grant/Funding Number: Brottsofferfonden)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized data will be uploaded to a repository managed by Karolinska Institutet.
• IPD Sharing Time Frame: Data will become available maximum three months after publication and remain available for an indefinite amount of time.

IPD Sharing Access Criteria

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 Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No