RecruitingNot ApplicableNCT07610187

A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program

Internetförmedlad Psykoterapi för Att Behandla Posttraumatiskt Stressyndrom Efter Sexuella övergrepp


Sponsor

Karolinska Institutet

Enrollment

140 participants

Start Date

May 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • + 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 Criteria1

  • 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.

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Interventions

BEHAVIORALRestory

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.


Locations(1)

Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet

Stockholm, Sweden

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NCT07610187


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