A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program

NCT07610187 | Recruiting

• 3 other identifiers: Dnr 2025-08612-0104904/20242024-116
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD - Post Traumatic Stress Disorder; Sexual Abuse

Keywords

PTSD treatment; Anonymous; Sexual Abuse; Trauma; Online

Outcome Measures

Primary Outcomes (1)

• PTSD symptom severity score, as measured by PCL-5

  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

Secondary Outcomes (7)

• 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?

  From baseline to end of treatment at 8 weeks

• 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

  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

  From post treatment to 1-month and 6-month follow-up

Other Outcomes (3)

• 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

  From baseline to end of treatment and 1-month and 6-month follow-up

• Negative post-traumatic cognitions, measured with the PTCI-9

  From baseline to end of treatment and 1-month and 6-month follow-up

Study Arms (2)

Restory

EXPERIMENTAL

A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse

Behavioral: Restory

Waitlist

NO INTERVENTION

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.

Interventions

Restory BEHAVIORAL

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.

Restory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Göteborg University: collaborator
• Linkoeping University: collaborator

Study Sites (1)

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

Stockholm, 11364, Sweden

RECRUITING

Related Links

• Preregistration on osf.io

MeSH Terms

Conditions

Combat Disorders; Wounds and Injuries

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Malin Joleby, PhD

CONTACT

+46736971237; malin.joleby@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Specialist, PhD

Model Details: Parallel assignment. An academically initiated randomized controlled clinical trial where Restory is compared with waitlist control. Participants on waitlist will cross over and receive treatment after waitlist.

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: May 27, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): May 4, 2027
• Study Completion (Estimated): November 4, 2027
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will become available maximum three months after publication and remain available for an indefinite amount of time.
• Access Criteria: 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.

Locations

SE (1)