Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07610187

Internet-Delivered Psychotherapy to Treat Post-Traumatic Stress Disorder After Sexual Abuse Using Restory Program

Led by Karolinska Institutet · Updated on 2026-05-27

140

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

K

Karolinska Institutet

Lead Sponsor

G

Göteborg University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate Restory, a newly developed anonymous internet-delivered cognitive behavioral therapy (iCBT) program focused on prolonged exposure therapy specifically designed for adult victims of sexual abuse with PTSD. The study investigates whether Restory is more effective than a waitlist control in reducing PTSD symptom severity. This trial responds to the need for accessible, low-threshold treatment options that address stigma, shame, and confidentiality concerns common among sexual abuse survivors, including underserved minority groups and males. Participants in the study are randomly assigned to either the Restory treatment group or a waitlist control group. Restory consists of eight weekly modules that combine core prolonged exposure therapy elements with targeted psychoeducation about shame, guilt, disgust, and sexuality. Each module includes educational content, explanations of the therapy, homework assignments, and personalized therapist feedback. The waitlist group waits at least nine weeks before starting treatment but completes the same assessments during the waiting period. During the study, participants complete questionnaires at baseline, after eight weeks of treatment or waitlist, and at one- and six-month follow-ups to measure PTSD severity using tools like PCL-5 and ITQ, as well as depressive symptoms with MADRS-S. The study tracks symptom changes, safety, and adherence to the program. Participation involves self-referral and registration via an online platform, enabling flexible and private access to care without physical clinic visits. The total study duration includes treatment and follow-up assessments over several months.

CONDITIONS

Brief Title

A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Experienced sexual violence with at least 1 month since the incident
  • Self-reported PTSD symptom severity score of 30 or higher on PCL-5
  • Stable dose of psychotropic medication for at least 4 weeks or medication free
  • Sufficient skills in Swedish language
  • Willingness and availability to participate in the study
Not Eligible

You will not qualify if you...

  • Ongoing trauma-related threat such as living with a violent spouse
  • Severe psychiatric illness needing immediate alternative treatment (e.g., high suicide risk or psychotic episode)
  • Currently receiving other trauma-focused CBT or Eye Movement Desensitization and Reprocessing therapy
  • Current benzodiazepine treatment
  • No trauma memory available

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Outpatient Treatment

Duration - 8 weeks

Participants complete the Restory program, an internet-delivered cognitive behavioral therapy tailored for victims of sexual abuse, consisting of eight modules over eight weeks with personalized therapist feedback.

Weekly online sessions

Follow-up

Duration - 6 months

Participants are monitored after completing treatment to assess PTSD and related symptoms at 1 month and 6 months post-treatment.

2 follow-up assessments

Trial Site Locations

Total: 1 location

1

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

Stockholm, Sweden, 11364

Actively Recruiting

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Research Team

M

Malin Joleby, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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