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

NCT03850639 | Unknown

• 1 other identifier: EPN 2018/2365-31
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months

• Montgomery Åsberg Depression Rating Scale - Self-report (MADRS-S)

  Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months

• Euroqol, EQ-5D

  Baseline (day 0-7), post-treatment (day 28-35) and follow-up 6 months

Study Arms (2)

Internet-based exposure therapy

EXPERIMENTAL

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

Wait list control

NO INTERVENTION

Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 4 weeks.

Interventions

Internet-based exposure therapy BEHAVIORAL

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.

Internet-based exposure therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

Related Publications (1)

• Bragesjo M, Arnberg FK, Andersson E. Mediators of change in a condensed online exposure-based intervention provided soon after trauma: insights from a randomised controlled trial. Eur J Psychotraumatol. 2024;15(1):2430807. doi: 10.1080/20008066.2024.2430807. Epub 2024 Dec 2.

  PMID: 39621100 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Erik Andersson, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 4 weeks.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 22, 2019
• Study Start: February 28, 2019
• Primary Completion: December 2, 2020
• Study Completion: June 5, 2021
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)