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 Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03850639
• Other study ID #: EPN 2018/2365-31
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 28, 2019
• Est. completion date: June 5, 2021

Study information

• Verified date: October 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: June 5, 2021
• Est. primary completion date: December 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Internet-based exposure therapy
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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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