- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07610187
A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program (Restory)
Internetförmedlad Psykoterapi för Att Behandla Posttraumatiskt Stressyndrom Efter Sexuella övergrepp
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Malin Joleby, PhD
- Numer telefonu: +46736971237
- E-mail: malin.joleby@ki.se
Lokalizacje studiów
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Stockholm, Szwecja, 11364
- Rekrutacyjny
- Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
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Kontakt:
- Malin Joleby, PhD
- Numer telefonu: +46736971237
- E-mail: malin.joleby@ki.se
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Główny śledczy:
- Malin Joleby, PhD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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PTSD symptom severity score, as measured by PCL-5
Ramy czasowe: 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?
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From baseline to end of treatment at 8 weeks
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
PTSD symptom severity score, as measured by the PTSD-part of the ITQ
Ramy czasowe: 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?
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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?
Ramy czasowe: 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?
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From baseline to end of treatment at 8 weeks
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Depressive symptoms, as measured by MADRS-S
Ramy czasowe: 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?
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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
Ramy czasowe: 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?
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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
Ramy czasowe: 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?
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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
Ramy czasowe: 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?
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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 an 6-month follow-up
Ramy czasowe: 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?
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From after treatment to 1-month and 6-month follow-up
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Quality of life, measured with the AQoL-8D
Ramy czasowe: From baseline to end of treatment and 1-month and 6-month follow-up
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Is Restory more effective than a waitlist control in increasing quality of life, measured with the AQoL-8D?
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From baseline to end of treatment and 1-month and 6-month follow-up
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Trauma-related shame, measured with the TRSI-24
Ramy czasowe: From baseline to end of treatment and 1-month and 6-month follow-up
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Is Restory more effective than a waitlist control in reducing trauma-related shame, measured with the TRSI-24?
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From baseline to end of treatment and 1-month and 6-month follow-up
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Negative post-traumatic cognitions, measured with the PTCI-9
Ramy czasowe: From baseline to end of treatment and 1-month and 6-month follow-up
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Is Restory more effective than a waitlist control in reducing negative post-traumatic cognitions, measured with the PTCI-9?
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From baseline to end of treatment and 1-month and 6-month follow-up
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Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Dnr 2025-08612-01
- 2024-116 (Inny numer grantu/finansowania: Fredrik och Ingrid Thurings stiftelse)
- 04904/2024 (Inny numer grantu/finansowania: Brottsofferfonden)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Ramy czasowe udostępniania IPD
Kryteria dostępu do udostępniania IPD
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.
Typ informacji pomocniczych dotyczących udostępniania IPD
- PROTOKÓŁ BADANIA
- SOK ROŚLINNY
- ICF
- ANALITYCZNY_KOD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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