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

NCT04101942 | Completed

• 1 other identifier: EPN
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up

• Euroqol, EQ-5D

  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)

  Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up

• Adverse Events

  Baseline, post treatment week 3, one-month follow up, 6 month follow up and 12 month follow up

Study Arms (2)

Internet-based CBT

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 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

Control condition (assessment only)

NO INTERVENTION

Waitlist control, i.e. no active active intervention during waiting list period. Will be offered treatment after 7 weeks.

Interventions

Internet-based CBT BEHAVIORAL

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.

Internet-based CBT

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 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

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 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)

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, licensed psychologist

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 22, 2019
• First Posted: September 24, 2019
• Study Start: February 28, 2019
• Primary Completion: October 5, 2019
• Study Completion: September 6, 2020
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)