Early Support After Exposure to Trauma

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).

Conditions

• Post-traumatic Stress Disorder

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.

Sponsors & Collaborators

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

  collaborator UNKNOWN

• NORCE Norwegian Research Centre AS

  collaborator OTHER

• Karolinska Institutet

  collaborator OTHER

• The Research Council of Norway

  collaborator OTHER

• Norwegian Center for Violence and Traumatic Stress Studies

  lead OTHER

Principal Investigators

• Harald Bækkelund, PhD · Norwegian Center for Violence and Traumatic Stress Studies

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-13

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Norway

Study Locations