Actively Recruiting

Phase Not Applicable
Age: 16Years - 99Years
All Genders
NCT06592677

Early Support After Exposure to Trauma

Led by Norwegian Center for Violence and Traumatic Stress Studies · Updated on 2026-03-23

360

Participants Needed

29

Research Sites

172 weeks

Total Duration

On this page

Sponsors

N

Norwegian Center for Violence and Traumatic Stress Studies

Lead Sponsor

R

Regional Centre - Violence, Trauma and Suicide Prevention - Region East (RVTS-East)

Collaborating Sponsor

AI-Summary

What this Trial Is About

A significant proportion of people who are exposed to traumatic events suffer from post-traumatic sequelae, such as post-traumatic stress disorder (PTSD). Indicated preventive interventions soon after trauma could be appropriate. Yet, there is limited evidence for the efficacy of such interventions. Moreover, no evidence-based preventive interventions are readily available for victims in the aftermath of crises and disasters in Norway. Condensed Internet-delivered Prolonged Exposure (CIPE) is a preventive intervention designed for victims with symptoms of PTSD (PTSS) approximately one month after a traumatic event. The treatment is an internet-delivered, therapist assisted intervention, based on principles from Prolonged Exposure. CIPE has proven to be feasible, safe, and effective in previous studies. This study aims to test the effectiveness and cost-effectiveness of CIPE in the context of psychosocial crisis services in Norwegian municipalities. Hypotheses Effectiveness H1 Participants receiving CIPE + treatment as usual (TAU) will have significantly less PTSS than participants receiving TAU at 6 weeks post T1, and at 6-, and 12- months after the traumatic incident. H2 Significantly fewer participants receiving CIPE+TAU will fulfill the criteria for PTSD compared to participants receiving TAU, at 6- and 12-months post trauma. H3 Participants receiving CIPE+TAU will have significantly less symptoms of depression and insomnia than participants receiving TAU at 6 weeks post T1, and at 6-, and 12- months after the traumatic incident. H4 Participants in the CIPE+TAU-condition will report significantly higher treatment satisfaction at post-treatment, compared to those in the TAU-condition. H5 Participants with traumatic loss receiving CIPE+TAU will have significantly less symptoms of prolonged grief than such participants receiving TAU 12 months after the loss. Cost-effectiveness H6 Fewer participants in the CIPE+TAU-condition will be referred to second-tier specialty mental health services, and more will achieve improved quality of life within the first year after the traumatic incident, compared to participants in the TAU-condition. H7 The CIPE+TAU implementation is more cost-effective compared to the TAU in the short run and may even dominate TAU in the long run (i.e., more effective and less costly).

CONDITIONS

Official Title

Early Support After Exposure to Trauma

Who Can Participate

Age: 16Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Receives support from a municipal crisis team
  • Experienced a traumatic event within the last 7 weeks before randomization
  • Has a total score of 10 or above on the PTSD Symptom Checklist-5 at randomization
  • Is aged 16 years or older
  • Provides written informed consent
  • Can write and speak English and/or Norwegian
Not Eligible

You will not qualify if you...

  • Has severe mental health problems needing specialized care (e.g., psychotic symptoms or high suicide risk) or substance dependence needing specialized care
  • Has known or obvious severe cognitive impairment
  • Is currently experiencing ongoing trauma, violence, or threats
  • Has had an unstable dose of psychotropic medication in the 2 weeks before randomization
  • Is receiving therapy elsewhere before randomization

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 29 locations

1

Asker municipality - Psychosocial crisis team

Asker, Asker, Norway, 1384

Actively Recruiting

2

Psychosocial crisis team - Indre Østfold kommune

Askim, Askim, Norway, 1830

Actively Recruiting

3

Psychosocial crisis team - Oslo, St Hanshaugen

Oslo, Oslo, Norway, 0170

Actively Recruiting

4

Psychosocial crisis team - Oslo, Ullern

Oslo, Oslo, Norway, 0377

Actively Recruiting

5

Norwegian Center for Violence and Traumatic Stress Studies

Oslo, Oslo, Norway, 0484

Actively Recruiting

6

Psychosocial crisis team - Oslo, Nordre Aker

Oslo, Oslo, Norway, 0484

Actively Recruiting

7

Psychosocial crisis team - Oslo, Østensjø

Oslo, Oslo, Norway, 0694

Actively Recruiting

8

Psychosocial crisis team - Oslo, Vestre Aker

Oslo, Oslo, Norway, 0754

Actively Recruiting

9

Psychosocial crisis team - Oslo, Grorud

Oslo, Oslo, Norway, 0954

Actively Recruiting

10

Psychosocial crisis team - Oslo, Alna

Oslo, Oslo, Norway, 1051

Actively Recruiting

11

Psychosocial crisis team - Oslo, Søndre Nordstrand

Oslo, Oslo, Norway, 1203

Actively Recruiting

12

Aurskog-Høland - Psychosocial crisis team

Bjørkelangen, Norway

Actively Recruiting

13

Fredrikstad municipality - Psychosocial Crisis team

Fredrikstad, Norway

Actively Recruiting

14

Gjøvik municipality - psychosocial crisis team

Gjøvik, Norway

Actively Recruiting

15

Halden Municipality - psychosocial crisis team

Halden, Norway

Actively Recruiting

16

Hamar Municipality - psychosocial crisis team

Hamar, Norway

Actively Recruiting

17

Søndre Land municipality - psychosocial crisis team

Hov, Norway

Actively Recruiting

18

Ullensaker municipality - psychosocial crisis team

Jessheim, Norway

Actively Recruiting

19

Psychosocial crisis team - Oslo, Bjerke

Oslo, Norway

Actively Recruiting

20

Psychosocial crisis team - Oslo, Frogner

Oslo, Norway

Actively Recruiting

21

Psychosocial crisis team - Oslo, gamle Oslo

Oslo, Norway

Actively Recruiting

22

Psychosocial crisis team - Oslo, Grünerløkka

Oslo, Norway

Actively Recruiting

23

Psychosocial crisis team - Oslo, Nordstrand

Oslo, Norway

Actively Recruiting

24

Psychosocial crisis team - Oslo, Sagene

Oslo, Norway

Actively Recruiting

25

Psychosocial crisis team - Oslo, Stovner

Oslo, Norway

Actively Recruiting

26

Psychosocial emergency service - Oslo emergency room

Oslo, Norway

Actively Recruiting

27

Ringsaker municipality - Psychosocial crisis team

Ringsaker, Norway

Actively Recruiting

28

Gjerdrum - psychosocial crisis team

Sørum, Norway

Actively Recruiting

29

Nannestad municipality - psychosocial crisis team

Teigebyen, Norway

Actively Recruiting

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Research Team

H

Harald Bækkelund, PhD

CONTACT

M

Marianne S Birkeland, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Early Support After Exposure to Trauma | DecenTrialz