Clinical trial NCT03850639: An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma
Official title: An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma: a Two-step Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of intrusion of the traumatic memory
timeFrame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Secondary outcomes:
measure: The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
measure: Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)
timeFrame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
measure: Euroqol, EQ-5D
timeFrame: Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References: