A Randomised Waitlist Controlled Clinical Trial of the Restory Treatment Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Restory
BehavioralRestory 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: RestoryExperimental treatment 1 intervention
Group B: WaitlistNo intervention 0 interventions
Trial outcomes
Primary outcomes
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?
Time frame
From baseline to end of treatment at 8 weeksSecondary outcomes
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?
Time frame
From baseline to end of treatment at 8 weeks2
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?
Time frame
From baseline to end of treatment at 8 weeks3
Depressive symptoms, as measured by MADRS-S
Is Restory more effective than a waitlist control in reducing depressive symptoms, as measured by MADRS-S?
Time frame
From baseline to end of treatment at 8 weeks4
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?
Time frame
From post treatment to 1-month and 6-month follow-upOther outcomes
1
Quality of life, measured with the AQoL-8D
Is Restory more effective than a waitlist control in increasing quality of life, measured with the AQoL-8D?
Time frame
From baseline to end of treatment and 1-month and 6-month follow-up2
Trauma-related shame, measured with the TRSI-24
Is Restory more effective than a waitlist control in reducing trauma-related shame, measured with the TRSI-24?
Time frame
From baseline to end of treatment and 1-month and 6-month follow-up3
Negative post-traumatic cognitions, measured with the PTCI-9
Is Restory more effective than a waitlist control in reducing negative post-traumatic cognitions, measured with the PTCI-9?
Time frame
From baseline to end of treatment and 1-month and 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov