Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06592677
NA

Early Support After Exposure to Trauma

Sponsor: Norwegian Center for Violence and Traumatic Stress Studies

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

16 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2024-09-13

Completion Date

2027-12-31

Last Updated

2026-03-23

Healthy Volunteers

No

Interventions

BEHAVIORAL

Condensed internet-delivered prolonged exposure (CIPE)

'Condensed Internet-delivered Prolonged Exposure' (CIPE) is an intervention designed for victims with symptoms of post-traumatic stress disorder (PTSD) soon after a traumatic incident. CIPE is a therapist-supported intervention that consists of four modules delivered over the internet. Central CIPE-interventions include psychoeducation of normal post-traumatic reactions, in-vivo exposure, imaginary exposure, and a breathing exercise.

BEHAVIORAL

Treatment-as-usual (TAU)

There is currently considerable heterogeneity regarding the interventional principles applied in the Treatment-as-usual (TAU) condition across municipal crisis teams. The national guidelines (The Norwegian Directorate of Health, 2016), recommends several interventional principles such as psychological first aid (PFA), psychoeducation regarding crisis reactions/symptoms of acute stress, normalization of such reactions, activation of social support, and practical assistance.

Locations (29)

Asker municipality - Psychosocial crisis team

Asker, Asker, Norway

Psychosocial crisis team - Indre Østfold kommune

Askim, Askim, Norway

Psychosocial crisis team - Oslo, St Hanshaugen

Oslo, Oslo County, Norway

Psychosocial crisis team - Oslo, Ullern

Oslo, Oslo County, Norway

Norwegian Center for Violence and Traumatic Stress Studies

Oslo, Oslo County, Norway

Psychosocial crisis team - Oslo, Nordre Aker

Oslo, Oslo County, Norway

Psychosocial crisis team - Oslo, Østensjø

Oslo, Oslo County, Norway

Psychosocial crisis team - Oslo, Vestre Aker

Oslo, Oslo County, Norway

Psychosocial crisis team - Oslo, Grorud

Oslo, Oslo County, Norway

Psychosocial crisis team - Oslo, Alna

Oslo, Oslo County, Norway

Psychosocial crisis team - Oslo, Søndre Nordstrand

Oslo, Oslo County, Norway

Aurskog-Høland - Psychosocial crisis team

Bjørkelangen, Norway

Fredrikstad municipality - Psychosocial Crisis team

Fredrikstad, Norway

Gjøvik municipality - psychosocial crisis team

Gjøvik, Norway

Halden Municipality - psychosocial crisis team

Halden, Norway

Hamar Municipality - psychosocial crisis team

Hamar, Norway

Søndre Land municipality - psychosocial crisis team

Hov, Norway

Ullensaker municipality - psychosocial crisis team

Jessheim, Norway

Psychosocial crisis team - Oslo, Bjerke

Oslo, Norway

Psychosocial crisis team - Oslo, Frogner

Oslo, Norway

Psychosocial crisis team - Oslo, gamle Oslo

Oslo, Norway

Psychosocial crisis team - Oslo, Grünerløkka

Oslo, Norway

Psychosocial crisis team - Oslo, Nordstrand

Oslo, Norway

Psychosocial crisis team - Oslo, Sagene

Oslo, Norway

Psychosocial crisis team - Oslo, Stovner

Oslo, Norway

Psychosocial emergency service - Oslo emergency room

Oslo, Norway

Ringsaker municipality - Psychosocial crisis team

Ringsaker, Norway

Gjerdrum - psychosocial crisis team

Sørum, Norway

Nannestad municipality - psychosocial crisis team

Teigebyen, Norway