A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program

Sponsor
Karolinska Institutet
Study ID
NCT07610187
Status
Recruiting
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Conditions

  • PTSD - Post Traumatic Stress Disorder
  • Sexual Abuse

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
May 27, 2026
Start date
May 4, 2026
Status verified
May 2026
Primary completion
May 4, 2027
Completion
Nov 4, 2027

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Restory
    A free, anonymous, internet-delivered prolonged exposure therapy program specifically tailored for victims of sexual abuse
  • No Intervention: Waitlist
    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.

Primary Outcome Measure

PTSD symptom severity score, as measured by PCL-5 [ Time Frame: From baseline to end of treatment at 8 weeks ]

Central Contacts

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