- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07610187
A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program (Restory)
Internetförmedlad Psykoterapi för Att Behandla Posttraumatiskt Stressyndrom Efter Sexuella övergrepp
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Malin Joleby, PhD
- Telefonní číslo: +46736971237
- E-mail: malin.joleby@ki.se
Studijní místa
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Stockholm, Švédsko, 11364
- Nábor
- Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
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Kontakt:
- Malin Joleby, PhD
- Telefonní číslo: +46736971237
- E-mail: malin.joleby@ki.se
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Vrchní vyšetřovatel:
- Malin Joleby, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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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Žádný zásah: 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PTSD symptom severity score, as measured by PCL-5
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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PTSD symptom severity score, as measured by the PTSD-part of the ITQ
Časové okno: 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?
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Quality of life, measured with the AQoL-8D
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Dnr 2025-08612-01
- 2024-116 (Jiné číslo grantu/financování: Fredrik och Ingrid Thurings stiftelse)
- 04904/2024 (Jiné číslo grantu/financování: Brottsofferfonden)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Časový rámec sdílení IPD
Kritéria přístupu pro sdílení 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 podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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