Early Support After Exposure to Trauma (EASE)

Norwegian Center for Violence and Traumatic Stress Studies

Status: Enrolling

Conditions: Post-traumatic Stress Disorder

Treatments: Behavioral: Treatment-as-usual (TAU); Behavioral: Condensed internet-delivered prolonged exposure (CIPE)

Study type: Interventional

Funder types: Other

Identifiers

NCT06592677

302302

Details and patient eligibility

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).

Enrollment: 360 estimated patients

Sex: All

Ages: 16 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups

Condensed internet-delivered prolonged exposure (CIPE) + Treatment-as-usual (TAU)

Experimental group

Description:

Participants in this condition will receive Treatment-as-usual (TAU) from psychosocial crisis teams throughout the entire participation period (1 year post trauma), in addition to CIPE as an add-on lasting for six weeks after randomization (T1; randomization from 4 to 7 weeks, dependent on when the participant is recruited). In CIPE, participants are encouraged to have daily contact with their therapist through a secured email system within the platform. Therapists are also available for phone sessions. Total therapist contact for each participant is generally less than 60 minutes during the whole program. Participants are expected to work on intervention tasks for six hours each week and to complete the intervention in three weeks. The intervention is delivered by psychosocial crisis teams' staff in 14 municipalities in the central-eastern part of Norway. Content, frequency, and quantity of the CIPE+TAU-condition will be measured.

Treatment:

Behavioral: Condensed internet-delivered prolonged exposure (CIPE)

Behavioral: Treatment-as-usual (TAU)

Treatment-as-usual (TAU) only

Active Comparator group

Description:

Participants in this condition will receive Treatment-as-usual (TAU) throughout the entire participation period (1 year post trauma). The TAU-condition is delivered by the same municipality psychosocial crisis teams as the Condensed internet-delivered prolonged exposure (CIPE) +TAU arm. The crisis teams follow a national guideline (The Norwegian Directorate of Health, 2016), recommending proactive contact with victims, screening for psychosocial difficulties, and offering interventions to individuals with significant levels of trauma-related problems. Most municipalities organize interdisciplinary crisis services consisting of physicians, police, priests, nurses, and psychologists who receive referrals from emergency services after a traumatic event. There is currently considerable heterogeneity in the frequenzy and quantity of intervention across municipalities.

Treatment:

Behavioral: Treatment-as-usual (TAU)