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A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program (Restory)

20 mai 2026 mis à jour par: Malin Joleby, Karolinska Institutet

Internetförmedlad Psykoterapi för Att Behandla Posttraumatiskt Stressyndrom Efter Sexuella övergrepp

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.

Aperçu de l'étude

Statut

Recrutement

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

140

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

      • Stockholm, Suède, 11364
        • Recrutement
        • Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
        • Contact:
        • Chercheur principal:
          • Malin Joleby, PhD

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Restory
A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse
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.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
PTSD symptom severity score, as measured by PCL-5
Délai: 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?
From baseline to end of treatment at 8 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
PTSD symptom severity score, as measured by the PTSD-part of the ITQ
Délai: 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?
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?
Délai: 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?
From baseline to end of treatment at 8 weeks
Depressive symptoms, as measured by MADRS-S
Délai: 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?
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
Délai: 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?
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
Délai: 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?
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
Délai: 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?
Post treatment to 1-month and 6-month follow-up
Depressive symptoms, as measured by MADRS-S at 1-month an 6-month follow-up
Délai: 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?
From after treatment to 1-month and 6-month follow-up

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Quality of life, measured with the AQoL-8D
Délai: From baseline to end of treatment and 1-month and 6-month follow-up
Is Restory more effective than a waitlist control in increasing quality of life, measured with the AQoL-8D?
From baseline to end of treatment and 1-month and 6-month follow-up
Trauma-related shame, measured with the TRSI-24
Délai: From baseline to end of treatment and 1-month and 6-month follow-up
Is Restory more effective than a waitlist control in reducing trauma-related shame, measured with the TRSI-24?
From baseline to end of treatment and 1-month and 6-month follow-up
Negative post-traumatic cognitions, measured with the PTCI-9
Délai: From baseline to end of treatment and 1-month and 6-month follow-up
Is Restory more effective than a waitlist control in reducing negative post-traumatic cognitions, measured with the PTCI-9?
From baseline to end of treatment and 1-month and 6-month follow-up

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

4 mai 2026

Achèvement primaire (Estimé)

4 mai 2027

Achèvement de l'étude (Estimé)

4 novembre 2027

Dates d'inscription aux études

Première soumission

20 mai 2026

Première soumission répondant aux critères de contrôle qualité

20 mai 2026

Première publication (Réel)

27 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

27 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • Dnr 2025-08612-01
  • 2024-116 (Autre subvention/numéro de financement: Fredrik och Ingrid Thurings stiftelse)
  • 04904/2024 (Autre subvention/numéro de financement: Brottsofferfonden)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Anonymized data will be uploaded to a repository managed by Karolinska Institutet.

Délai de partage IPD

Data will become available maximum three months after publication and remain available for an indefinite amount of time.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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