RecruitingNot Applicable

A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program

Sweden140 participantsStarted 2026-05-04

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PTSD symptom severity score, as measured by PCL-5

Timeframe: From baseline to end of treatment at 8 weeks

Trial details

NCT IDNCT07610187

SponsorKarolinska Institutet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-04

Contact for this trial

Malin Joleby, PhD

+46736971237 malin.joleby@ki.se

View on ClinicalTrials.gov More PTSD - Post Traumatic Stress Disorder trials