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RECRUITINGINTERVENTIONAL

Early Support After Exposure to Trauma

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

Who May Be Eligible (Plain English)

Who May Qualify: - Receives support from a municipal crisis team - Exposure to a traumatic event (as defined by criteria A for the diagnosis of post-traumatic stress disorder (PTSD) in the DSM-5) within the last seven weeks before randomization - A total score of 10 or above on the PTSD Symptom Checklist-5 at the time of randomization - Age 16 or above - Written willing to sign a consent form - Writes and speaks English and/or Norwegian Who Should NOT Join This Trial: - Severe psychopathology in need of specialized health care (e.g., psychotic symptoms, or high suicide risk) or substance dependence syndrome in need of specialized health care - Known or evident severe cognitive impairment - Ongoing traumatization, violence, or threats - Unstable dose of psychotropic medication two weeks prior to randomization - Concurrent therapy elsewhere before randomization Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Receives support from a municipal crisis team * Exposure to a traumatic event (as defined by criteria A for the diagnosis of post-traumatic stress disorder (PTSD) in the DSM-5) within the last seven weeks before randomization * A total score of 10 or above on the PTSD Symptom Checklist-5 at the time of randomization * Age 16 or above * Written informed consent * Writes and speaks English and/or Norwegian Exclusion Criteria: * Severe psychopathology in need of specialized health care (e.g., psychotic symptoms, or high suicide risk) or substance dependence syndrome in need of specialized health care * Known or evident severe cognitive impairment * Ongoing traumatization, violence, or threats * Unstable dose of psychotropic medication two weeks prior to randomization * Concurrent therapy elsewhere before randomization

Treatments Being Tested

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 (20)

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