- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07610187
Evaluation of Restory - an Online Trauma Treatment for Victims of Sexual Abuse (Restory)
A Randomised Waitlist Controlled Clinical Trial of the Restory Trauma Treatment Program
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Malin Joleby, PhD
- Telefonnummer: +46736971237
- E-mail: malin.joleby@ki.se
Studiesteder
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Stockholm, Sverige, 11364
- Rekruttering
- Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
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Kontakt:
- Malin Joleby, PhD
- Telefonnummer: +46736971237
- E-mail: malin.joleby@ki.se
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Ledende efterforsker:
- Malin Joleby, PhD
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Restory
A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse
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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.
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Ingen indgriben: 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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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PTSD symptom severity score, as measured by PCL-5
Tidsramme: From baseline to end of treatment at 8 weeks
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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.
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From baseline to end of treatment at 8 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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PTSD symptom severity score, as measured by the PTSD-part of the ITQ
Tidsramme: From baseline to end of treatment at 8 weeks
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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.
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From baseline to end of treatment at 8 weeks
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Complex-PTSD symptom severity score, as measured by the Disturbances in Self-Organization part of ITQ?
Tidsramme: From baseline to end of treatment at 8 weeks
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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.
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From baseline to end of treatment at 8 weeks
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Depressive symptoms, as measured by MADRS-S
Tidsramme: From baseline to end of treatment at 8 weeks
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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.
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From baseline to end of treatment at 8 weeks
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PTSD symptom severity score, as measured by the PCL-5 at 1- and 6-month follow-up
Tidsramme: From post treatment to 1-month and 6-month follow-up
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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.
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From post treatment to 1-month and 6-month follow-up
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PTSD symptom severity score, as measured by the PTSD-part of the ITQ, at 1-month and 6-month follow-up
Tidsramme: From post treatment to 1-month and 6-month follow-up
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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.
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From post treatment to 1-month and 6-month follow-up
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Complex-PTSD symptom severity score, as measured by the Disturbances in Self- Organization part of ITQ at 1-month and 6-month follow-up
Tidsramme: Post treatment to 1-month and 6-month follow-up
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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.
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Post treatment to 1-month and 6-month follow-up
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Depressive symptoms, as measured by MADRS-S at 1-month and 6-month follow-up
Tidsramme: From after treatment to 1-month and 6-month follow-up
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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.
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From after treatment to 1-month and 6-month follow-up
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of life, measured with the AQoL-8D
Tidsramme: From baseline to end of treatment at 8 weeks
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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.
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From baseline to end of treatment at 8 weeks
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Trauma-related shame, measured with the TRSI-24
Tidsramme: From baseline to end of treatment at 8 weeks
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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.
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From baseline to end of treatment at 8 weeks
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Negative post-traumatic cognitions, measured with the PTCI-9
Tidsramme: From baseline to end of treatment at 8 weeks
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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.
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From baseline to end of treatment at 8 weeks
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Quality of life, measured with the AQoL-8D at 1-month and 6-month follow-up
Tidsramme: From after treatment to 1-month and 6-month follow-up
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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.
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From after treatment to 1-month and 6-month follow-up
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Trauma-related shame, measured with the TRSI-24 at 1-month and 6-month follow-up
Tidsramme: From after treatment to 1-month and 6-month follow-up
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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.
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From after treatment to 1-month and 6-month follow-up
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Negative post-traumatic cognitions, measured with the PTCI-9 at 1-month and 6-month follow-up
Tidsramme: From after treatment to 1-month and 6-month follow-up
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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.
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From after treatment to 1-month and 6-month follow-up
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Dnr 2025-08612-01
- 2024-116 (Andet bevillings-/finansieringsnummer: Fredrik och Ingrid Thurings stiftelse)
- 04904/2024 (Andet bevillings-/finansieringsnummer: Brottsofferfonden)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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