Evaluation of Restory - an Online Trauma Treatment for Victims of Sexual Abuse
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
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
Disqualifiers
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
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 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.
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 (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
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 (International Trauma Questionnaire)? Scores range from 0 to 24, with higher scores indicating greater symptom severity.
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 (Montgomery Åsberg Depression Rating Scale)? Scores range from 0 to 54, with higher scores indicating greater symptom severity.
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 (Posttraumatic Stress Disorder Checklist, version 5)? Scores range from 0 to 80, with higher scores indicating greater symptom severity.
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 (Assessment of Quality of Life - 8 Dimensions)? The AQoL-8D has 35 items and eight dimensions. Items have different response levels, each representing increasing levels of severity.
Time frame
From baseline to end of treatment at 8 weeks2
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 (Trauma-Related Shame Inventory)? Scores range from 0 to 72, with higher scores indicating greater trauma-related shame.
Time frame
From baseline to end of treatment at 8 weeks3
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 (Posttraumatic Cognitions Inventory)? Scores range from 9 to 63, with higher scores indicating more negative trauma-related cognitions.
Time frame
From baseline to end of treatment at 8 weeks4
Quality of life, measured with the AQoL-8D 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 quality of life, measured with the AQoL-8D (Assessment of Quality of Life - 8 Dimensions)? The AQoL-8D has 35 items and eight dimensions. Items have different response levels, each representing increasing levels of severity.
Time frame
From after treatment to 1-month and 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov