An Internet-delivered Cognitive-behavioral Intervention Provided Soon After Trauma: a RCT

Internet-delivered Prolonged Exposure Provided Soon After Traumic Events: An Efficacy Trial

The primary objective with this study is to investigate the short-term efficacy (primary endpoint at week 3) of Internet-delivered cognitive behavior therapy (ICBT) provided soon after trauma. The secondary objective is to investigate the long-term efficacy (primary endpoint at week 7) of ICBT. 100 participants recently exposed to a potentially traumatic event will be randomised to either ICBT or assessment only.

Study Overview

• Status: Completed
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Internet-based CBT

Detailed Description

PRIMARY OBJECTIVE

The primary objective with this study is to investigate the short-term efficacy (primary endpoint at week 3) of Internet-delivered cognitive behavior therapy (ICBT) provided soon after trauma.

SECONDARY OBJECTIVES The secondary objective is to investigate the long-term efficacy (primary endpoint at week 7) of ICBT.

Trial design: Randomized trial where participants are allocated to either ICBT (n=50) or control group (assessment only; n=50). Participants randomized to control group are subsequently offered identical ICBT treatment, so that all participants will eventually receive treatment.

All participants are assessed at baseline (W0), post-treatment (primary endpoint; W3) and at one-month follow-up (secondary endpoint; W7). Long-term follow-up assessments are also conducted at 6- and 12-months. The primary outcome measure is also measured weekly from baseline and up to the 1-month follow-up (W7).

Primary outcome measure used are the Posttraumatic Stress Disorder Checklist for Diagnostic and Statical Manual, Fifth Edition (PCL-5). Secondary outcome measures used are Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S), Euroqol (EQ-5D) and Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P).

Participants are self-referred through advertisements in newspapers, web-pages, social media and at primary care, psychiatric and emergency clinics throughout Sweden. Interested applicants do an Internet-administered screening on an encrypted webpage using the PCL-5, MADRS-S, Alcohol User Disorders Identification Test (AUDIT), Drug User Disorders Identification Test (DUDIT), TIC-P, questions about inclusion and exclusion criteria and also give general background information. Written information about the study is given including objectives, benefits, risks and requirements imposed by the study.

An assessor calls the participant and conducts a structured clinical interview including The Mini-International Neuropsychiatric Interview (M.I.N.I.). The aim of this interview is to preliminary assess inclusion criteria and rule out exclusion criteria. Information is also given over the phone by the interviewer about the study protocol.

Safety parameters Participants will have the opportunity to report any adverse events during treatment, at posttreatment and follow-up assessment.

Data collection: Data will be collected electronically via the treatment platform.

Main statistical analysis: Between-group estimates on outcome are done using a mixed-effects regression model with repeated measurements. All analyses will be done according to intention to treat and post hoc per protocol analyses will also be conducted.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Karolinska Institutet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Experienced psychological trauma in the past two months according to criterion A for PTSD in the DSM-5 (exposed to death, threatened death, actual or threatened serious injury, or actual or threatened sexual violence).

  • At least mild clinical symptoms assessed using the PCL-5
  • ≥ 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 M.I.N.I.)
• Not fluent speaking in Swedish
• Receiving CBT for trauma-related symptoms
• Ongoing trauma-related threat (e.g. living with a violent spouse)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based CBT; 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 the experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 36 hours on weekdays	Behavioral: Internet-based CBT; 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 36 hours.
No Intervention: Control condition (assessment only); Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 7 weeks.

What is the study measuring?

Primary 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, during treatment to post treatment and follow up (6 and 12 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, weekly from baseline up to 1-month follow-up, 6 month follow up and 12 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)	Change in depressive symptoms from baseline to post treatment and follow up (1, 6 and 12 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, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up
Euroqol, EQ-5D	Change in overall health from baseline to post treatment and follow up (1, 6 and 12 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, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up
Trimbos and Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry (TIC-P)	Change in economic costs from baseline, post treatment, 1 month, 6 month and 12 months follow up. TIC-P collect data on medical consumption and productivity losses in patients with mild to moderate mental health problems. A higher score indicate worse severity.	Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up
Adverse Events	Number of adverse events from baseline, 1 month, 6 month and 12 months follow up.	Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Erik Andersson, PhD, Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2019
• Primary Completion (Actual): October 5, 2019
• Study Completion (Actual): September 6, 2020

Study Registration Dates

• First Submitted: September 22, 2019
• First Submitted That Met QC Criteria: September 22, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: EPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No