NCT07610187 A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program
| NCT ID | NCT07610187 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska Institutet |
| Condition | PTSD - Post Traumatic Stress Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-05-04 |
| Primary Completion | 2027-05-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 140 participants in total. It began in 2026-05-04 with a primary completion date of 2027-05-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07610187 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying PTSD - Post Traumatic Stress Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07610187 currently recruiting?
Yes, NCT07610187 is actively recruiting participants. Contact the research team at malin.joleby@ki.se for enrollment information.
Where is the NCT07610187 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT07610187 clinical trial?
NCT07610187 is sponsored by Karolinska Institutet. The trial plans to enroll 140 participants.
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