Early Support After Exposure to Trauma

Last updated: November 19, 2024
Sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Overall Status: Active - Recruiting

Phase

N/A

Condition

Panic Disorders

Post-traumatic Stress Disorders

Anxiety Disorders

Treatment

Condensed internet-delivered prolonged exposure (CIPE)

Treatment-as-usual (TAU)

Clinical Study ID

NCT06592677
302302
  • Ages 16-99
  • All Genders

Study 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 2.5-, 6-, and 12- months after the traumatic incident.

H2 Significantly fewer participants receiving CIPE+TAU will fulfill the criteria for PTSD than 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 2.5-, 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Receives support from a municipal crisis team

  • Exposure to a traumatic event (as defined by criteria A for the diagnosis ofpost-traumatic stress disorder (PTSD) in the DSM-5) within the last month beforerandomization

  • A total score of 10 or above on the PTSD Symptom Checklist-5 at the time ofrandomization

  • Age 16 or above

  • Written informed consent

  • Writes and speaks English and/or Norwegian

Exclusion

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 healthcare

  • 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

Study Design

Total Participants: 360
Treatment Group(s): 2
Primary Treatment: Condensed internet-delivered prolonged exposure (CIPE)
Phase:
Study Start date:
September 13, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Asker municipality - Psychosocial crisis team

    Asker, 1384
    Norway

    Active - Recruiting

  • Aurskog-Høland - Psychosocial crisis team

    Bjørkelangen,
    Norway

    Active - Recruiting

  • Fredrikstad municipality - Psychosocial Crisis team

    Fredrikstad,
    Norway

    Active - Recruiting

  • Gjøvik municipality - psychosocial crisis team

    Gjøvik,
    Norway

    Active - Recruiting

  • Halden Municipality - psychosocial crisis team

    Halden,
    Norway

    Active - Recruiting

  • Hamar Municipality - psychosocial crisis team

    Hamar,
    Norway

    Active - Recruiting

  • Søndre Land & Østre Toten municipalities - psychosocial crisis team

    Hov,
    Norway

    Active - Recruiting

  • Ullensaker municipality - psychosocial crisis team

    Jessheim,
    Norway

    Active - Recruiting

  • Østre Toten municipality - Psychosocial crisis team

    Lena,
    Norway

    Active - Recruiting

  • Norwegian Center for Violence and Traumatic Stress Studies

    Oslo, 0484
    Norway

    Active - Recruiting

  • Psychosocial crisis team - Oslo, Bjerke

    Oslo,
    Norway

    Active - Recruiting

  • Psychosocial crisis team - Oslo, Frogner

    Oslo,
    Norway

    Active - Recruiting

  • Psychosocial crisis team - Oslo, Grünerløkka

    Oslo,
    Norway

    Active - Recruiting

  • Psychosocial crisis team - Oslo, Nordstrand

    Oslo,
    Norway

    Active - Recruiting

  • Psychosocial crisis team - Oslo, Sagene

    Oslo,
    Norway

    Active - Recruiting

  • Psychosocial crisis team - Oslo, Stovner

    Oslo,
    Norway

    Active - Recruiting

  • Psychosocial crisis team - Oslo, gamle Oslo

    Oslo,
    Norway

    Active - Recruiting

  • Psychosocial emergency service - Oslo emergency room

    Oslo,
    Norway

    Active - Recruiting

  • Ringsaker municipality - Psychosocial crisis team

    Ringsaker,
    Norway

    Active - Recruiting

  • Gjerdrum - psychosocial crisis team

    Sørum,
    Norway

    Active - Recruiting

  • Nannestad municipality - psychosocial crisis team

    Teigebyen,
    Norway

    Active - Recruiting

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