Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
Stockholm, 11364, Sweden
Location status: Recruiting
NCT Number: NCT07610187
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Stockholm, 11364, Sweden
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Karolinska Institutet
Other
A Randomised Waitlist Controlled Clinical Trial of the Restory Trauma Treatment Program
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07280065
Anxiety Disorders, Behavior
Aurora, Colorado, United States
View Trial DetailsNCT06923423
Alcohol-Related Disorders, Alcoholism
Little Rock, Arkansas, United States
View Trial DetailsNCT07121270
Combat Disorders, Dyssomnias
Detroit, Michigan, United States
View Trial DetailsNCT07570654
Combat Disorders, Mental Disorders
View Trial Details