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PTSD - Post Traumatic Stress DisorderNCT07610187

Evaluation of Restory - an Online Trauma Treatment for Victims of Sexual Abuse

A study testing Restory in people with PTSD - Post Traumatic Stress Disorder and Sexual Abuse, run by Karolinska Institutet at 1 site in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Restory
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteSweden
Study dates
4 May 2026to 4 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Malin Joleby, PhD contact

+46736971237

malin.joleby@ki.se

Sweden1 site, 1 recruiting
  • Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet

    Stockholm, 11364

    Malin Joleby, PhD, +46736971237, malin.joleby@ki.se

    Malin Joleby, PhD

    Recruiting

Other trials in Sweden

About this study

Official title: A Randomised Waitlist Controlled Clinical Trial of the Restory Trauma Treatment Program

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.

Read the detailed description

Restory has been developed to address the current lack of available, low-threshold treatment for sexual abuse victims. Restory is a free, anonymous, trauma-focused, iCBT program. iCBT has been shown to be as effective as face-to-face treatment for several conditions. iCBT for PTSD has documented efficacy, regardless of the patient's age, and even intensive formats have proven feasible despite concerns about increased risk of dropout or symptom deterioration. There are indications that internet-based treatment can even enhance the patient's sense of self-efficacy since they are encouraged to take on a more active role in their treatment, which is particularly beneficial for individuals with PTSD facing negative self-cognitions.

A recent review of barriers to formal help-seeking following sexual victimization concluded that increasing resource availability and access is crucial. iCBT can thus play a pivotal role in breaking down barriers by providing nationwide access to care, regardless of geographical location, thus democratizing access to specialized care for an underserved patient population. By offering treatment anonymously, we believe we can further promote help-seeking by mitigating the stigma, guilt shame, and confidentiality concerns that often hinder victims of sexual abuse from seeking care. This is valuable for the patient group at large, but particularly beneficial for victim groups that are less likely to seek help, including minority groups (racial, ethnical, and sexual minorities), boys and men, victims of female offenders, and victims of technology-assisted sexual abuse as they may face heightened risk of experiencing shame, stigma, and cultural and social barriers. iCBT treatment can be conducted discreetly and flexibly online, accommodating the patient's schedule without the need for physical clinic visits, thereby reducing the risk of recognition. Overall, this approach aligns with the objective outlined by the Swedish Association of Local Authorities and Regions to ensure equitable care nationwide and to better address the needs of particularly vulnerable groups.

An important aspect of Restory, and a gap it aims to fill, is that it is a treatment program specifically designed for a unique patient group: victims of sexual abuse. This is crucial because sexual victimization is often associated with fear, anxiety, and shame, making the quality of the therapeutic encounter essential. The lack of specialized clinics means that victims of sexual abuse are often left to seek care through a regular medical center or emergency room, where the medical staff do not have any specific training in meeting this patient group. Research has indicated that women disclosing to both informal and formal supports reported more negative (e.g. victim blaming and disbelief) than positive reactions. These negative reactions have in turn been linked to adverse outcomes such as PTSD, depression, psychological and physical distress, and maladaptive coping. Hence, it is imperative that specialized care is provided by knowledgeable staff, and ideally with a treatment program specifically tailored to the unique needs of the patient group.

The project implements Public and Patient Involvement (PPI) from start to finish of the project. Experts from organisations working with this patient, and a patient representative with lived experience of sexual abuse, are part of an Advisory Board providing feedback on the planning of the studies and in the development of the treatment program.

The target population is adult victims of sexual abuse suffering from post-traumatic stress disorder. Interested individuals will self-refer and register via the study platform (www.restorystudien.se).

A Project Plan and a Statistical Analysis Plan (SAP) was pre-registered at the OSF platform (https://osf.io/mxf7t/overview) before recruitment commenced.

Being tested
Restory
Keywords
PTSD treatment, Anonymous, Sexual Abuse, Trauma, Online
Medical subject headings
Combat Disorders, Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RestoryBehavioural

    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.

Study groups in NCT07610187
Study groupRoleWhat they receive
RestoryExperimentalA free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse
Receives: Behavioral: Restory
WaitlistNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.

    Measured: From baseline to end of treatment at 8 weeks

Secondary outcomes (7)
  1. PTSD symptom severity score, as measured by the PTSD-part of the ITQ

    Is Restory more effective than a waitlist control in reducing PTSD symptom severity score, as measured by the PTSD-part of the ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.

    Measured: From baseline to end of treatment at 8 weeks

  2. Complex-PTSD symptom severity score, as measured by the Disturbances in Self-Organization part of ITQ?

    Is Restory more effective than a waitlist control in reducing Complex-PTSD symptom severity score, as measured by the Disturbances in Self-Organization part of ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.

    Measured: From baseline to end of treatment at 8 weeks

  3. Depressive symptoms, as measured by MADRS-S

    Is Restory more effective than a waitlist control in reducing depressive symptoms, as measured by MADRS-S (Montgomery Åsberg Depression Rating Scale)? Scores range from 0 to 54, with higher scores indicating greater symptom severity.

    Measured: From baseline to end of treatment at 8 weeks

  4. PTSD symptom severity score, as measured by the PCL-5 at 1- and 6-month follow-up

    Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for PTSD symptom severity score, as measured by the PCL-5 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.

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

  5. PTSD symptom severity score, as measured by the PTSD-part of the ITQ, at 1-month and 6-month follow-up

    Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for PTSD symptom severity score, as measured by the PTSD-part of the ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.

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

  6. Complex-PTSD symptom severity score, as measured by the Disturbances in Self- Organization part of ITQ at 1-month and 6-month follow-up

    Are treatment gains from Restory maintained or improved at 1-month follow-up and 6-month follow up for Complex-PTSD symptom severity score, as measured by the Disturbances in Self- Organization part of ITQ (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.

    Measured: Post treatment to 1-month and 6-month follow-up

  7. Depressive symptoms, as measured by MADRS-S at 1-month and 6-month follow-up

    Are treatment gains from Restory maintained or improved at 1-month follow up and 6-month follow up for depressive symptoms, as measured by MADRS-S (Montgomery Åsberg Depression Rating Scale)? Scores range from 0 to 54, with higher scores indicating greater symptom severity.

    Measured: From after treatment to 1-month and 6-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2026
  2. Study start4 May 2026
  3. Primary completion4 May 2027 (estimated)
  4. Study completion4 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07610187
Sponsor's protocol ID
Dnr 2025-08612-01
Other IDs
04904/2024, 2024-116
Status last verified
May 2026
First submitted
20 May 2026
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized data will be uploaded to a repository managed by Karolinska Institutet.

Questions about this trial

What is this clinical trial studying?

A study testing Restory in people with PTSD - Post Traumatic Stress Disorder and Sexual Abuse, run by Karolinska Institutet at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Malin Joleby, PhD (+46736971237, malin.joleby@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD symptom severity score, as measured by PCL-5 (time frame: From baseline to end of treatment at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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