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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Internet-based exposure therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Experienced psychological trauma according to criterium A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence) the past two months. Ongoing intrusive memories from this traumatic event ≥ 18 years Situated in Sweden Informed consent Exclusion Criteria: Other serious comorbidity as primary concern (ongoing substance dependence, untreated bipolar disorder, psychotic symptoms, severe depression, borderline personality disorder, high suicidal risk according to the MINI) Not fluent speaking in Swedish Receiving CBT for trauma Ongoing trauma-related threat (e.g. living with a violent spouse)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based exposure therapy<br>The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 48 hours. | Behavioral: Internet-based exposure therapy<br>* The treatment is a three week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach the memory of the traumatic event and situations they since the traumatic events are associated with fear and anxiety. Other interventions include psychoeducation, and breathing retraining to facilitate exposure.<br>|
| No Intervention: Wait list control<br>Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 4 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of intrusion of the traumatic memory | Change in self-report assessment of daily intrusions at baseline (day 0-7) and post-treatment (day 28-35). The participants are each day asked to report number of intrusive memories during morning, afternoon, evening and night through a smart phone app. If the participants don't have access to a smart phone, pen and stencil will be used. | Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | Change in symptoms of post traumatic stress from baseline to post treatment and follow up (6 months). The PTSD Checklist for DSM-5 (PCL-5) is a 20-item self-report measure that assesses the presence and severity of PTSD symptoms. All items are scored on a 0-4 scale. Higher score indicate worse severity. | Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months | 
| Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) | Change in depressive symptoms from baseline to post treatment and follow up (6 months). The Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S) is a 9 item self-report measure that assesses the presence and severity of depressive symptoms. All items are scored on a 0-6 scale. Higher score indicate worse severity. | Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months | 
| Euroqol, EQ-5D | Change in overall health from baseline to post treatment and follow up (6 months). EQ-5D is a standardised self-report measure of overall health status measured in terms of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension asks about the person's walking ability. Self-care dimension asks about the ability to wash or dress by oneself, and usual activities dimension measures performance in work, study, housework, family or leisure activities. In pain/discomfort dimension, it asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks how anxious or depressed they are. The respondents self-rate their level of severity for each dimension using a three-level scale: 1 having no problems, 2 having some problems and 3 having extreme problems. A higher score indicate worse severity. | Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months |