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An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma

Post Traumatic Stress Disorder Clinical Trial

Official title:
An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma: a Two-step Feasibility Trial

Clinical Trial Summary

The primary objective with this study is to investigate the feasibility of an internet-delivered cognitive-behavioral (CBT) intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment.

Clinical Trial Description

Objective The primary objective with this study is to investigate the feasibility of an internet-delivered psychological intervention provided soon after trauma (within 2 months). The secondary objective is to investigate the effects of the internet-delivered CBT intervention on intrusive memories compared to no treatment. Trial design We will first pre-pilot test the intervention- and assessment procedures in five participants (no randomization) which will be followed by a randomized controlled trial with waitlist control. The wait list control group will also receive treatment after the first group has finished. SAMPLE SIZE 5 plus 30 participants. ENDPOINTS Self-report assessment of daily intrusions at baseline and post-treatment SECONDARY ENDPOINTS The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) at baseline (and post-treatment Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) at baseline and post-treatment. Euroqol, EQ-5D at baseline and post-treatment. Recruitment Self-referral. Advertising will be made through national newspapers, social media, patient organisations' and ads directed to health care units, such as emergency departments, in Sweden. Safety parameters Participants will have the opportunity to report any adverse events during treatment at posttreatment and follow-up measurements. Data collection: Data will be collected electronically via the treatment platform and a safe app. Main statistical analysis: Between-group estimates on outcome are done using a mixed-effects regression model with a Poisson distribution. All analyses will be done according to intention to treat and post hoc per protocol analyses will also be conducted. The primary criterion is the estimated regression slope of daily intrusive memories between day 0-7 and day 28-35. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03850639
Study type Interventional
Source Karolinska Institutet
Contact
Status Active, not recruiting
Phase N/A
Start date February 28, 2019
Completion date June 5, 2021
View Details
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