An interventional study of Restory in PTSD - Post Traumatic Stress Disorder and Sexual Abuse, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
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.
200 studies on the registry are indexed under Combat Disorders; 90 are open to participants now.
This study's planned enrollment of 140 is above the median of 72 across 167 interventional studies indexed under Combat Disorders.
Browse Combat Disorders studies →Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.
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A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse
Behavioral: Restory
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.
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.
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 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.
Time frame: From baseline to end of treatment at 8 weeks
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 (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
Time frame: 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 (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
Time frame: 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 (Montgomery Åsberg Depression Rating Scale)? Scores range from 0 to 54, with higher scores indicating greater symptom severity.
Time frame: 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 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.
Time frame: 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 (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
Time frame: 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 (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
Time frame: 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
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.
Time frame: From after treatment to 1-month and 6-month follow-up
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 (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.
Time frame: From baseline to end of treatment at 8 weeks
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 (Trauma-Related Shame Inventory)? Scores range from 0 to 72, with higher scores indicating greater trauma-related shame.
Time frame: From baseline to end of treatment at 8 weeks
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 (Posttraumatic Cognitions Inventory)? Scores range from 9 to 63, with higher scores indicating more negative trauma-related cognitions.
Time frame: 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
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.
Time frame: 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
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.
Time frame: 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
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.
Time frame: From after treatment to 1-month and 6-month follow-up
Plan to share: Yes — Anonymized data will be uploaded to a repository managed by Karolinska Institutet.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will become available maximum three months after publication and remain available for an indefinite amount of time.
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.
Started May 2026 (actual). Primary completion is estimated for May 2027, 12 months after the start.
Of 73 non-industry interventional studies with no phase under Combat Disorders, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 44. This study's planned 12 months is below that.
Counting every sponsor, half of 79 studies reached it within 25 months; a quarter within 12 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
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