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NCT Number: NCT06592677

Early Support After Exposure to Trauma

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).

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asker municipality - Psychosocial crisis team, Asker, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Condensed internet-delivered prolonged exposure (CIPE)

Behavioral

'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.

Treatment-as-Usual (TAU)

Behavioral

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.

Primary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5; Norwegian version)

    Time frame: Post-treatment (10 - 13 weeks after trauma)

    20-item questionnaire that measures DSM-5-specified symptoms of post-traumatic stress disorder (PTSD). The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ("not at all") to 4 ("extremely") Likert type scale. The PCL-5 has demonstrated satisfactory psychometric properties in various trauma populations. This study will administer a Norwegian version of the PCL-5. Recall period: one month.

Secondary outcomes

  1. PTSD Checklist for DSM-5 (PCL-5; Norwegian version)

    Time frame: 6 months follow-up

    20-item questionnaire that measures DSM-5-specified symptoms of post-traumatic stress disorder (PTSD). The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ("not at all") to 4 ("extremely") Likert type scale. The PCL-5 has demonstrated satisfactory psychometric properties in various trauma populations. This study will administer a Norwegian version of the PCL-5. Recall period: one month.

  2. PTSD Checklist for DSM-5 (PCL-5; Norwegian version)

    Time frame: 12 months follow-up

    20-item questionnaire that measures DSM-5-specified symptoms of post-traumatic stress disorder (PTSD). The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ("not at all") to 4 ("extremely") Likert type scale. The PCL-5 has demonstrated satisfactory psychometric properties in various trauma populations. This study will administer a Norwegian version of the PCL-5. Recall period: one month.

  3. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)

    Time frame: 6-months follow-up

    30-item structured interview, developed to assess current and life-time post-traumatic stress disorder (PTSD)-diagnosis, as well as past-week PTSD symptoms. The instrument measures the 20 DSM-5 PTSD-symptoms, in addition to the onset and duration of symptoms, related subjective distress and functional impairment (social, occupational), amongst other aspects of the disorder. Standardized questions and probes are provided. A Norwegian version of the CAPS-5 are administered. CAPS-5 has demonstrated excellent psychometric properties.

  4. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)

    Time frame: 12-months follow-up

    30-item structured interview, developed to assess current and life-time post-traumatic stress disorder (PTSD)-diagnosis, as well as past-week PTSD symptoms. The instrument measures the 20 DSM-5 PTSD-symptoms, in addition to the onset and duration of symptoms, related subjective distress and functional impairment (social, occupational), amongst other aspects of the disorder. Standardized questions and probes are provided. A Norwegian version of the CAPS-5 are administered. CAPS-5 has demonstrated excellent psychometric properties.

  5. Patient Health Questionnaire (PHQ-9; Norwegian version)

    Time frame: Post-treatment (10 - 13 weeks after trauma)

    9-item self-report measure of depressive symptom severity. The recall period is 2 weeks. Response is given on a 4-point Likert scale (0: not at all, 1: several days, 2: more than half the days, and 3: nearly every day), resulting in the total score ranging from 0 to 27. Higher scores indicate higher symptom severity. The instrument is sensitive for both clinical- and sub-clinical levels of depressive symptoms, and have demonstrated favorable psychometric properties. A validated Norwegian version of the PHQ-9 is applied.

  6. Patient Health Questionnaire (PHQ-9; Norwegian version)

    Time frame: 6-months follow-up

    9-item self-report measure of depressive symptom severity. The recall period is 2 weeks. Response is given on a 4-point Likert scale (0: not at all, 1: several days, 2: more than half the days, and 3: nearly every day), resulting in the total score ranging from 0 to 27. Higher scores indicate higher symptom severity. The instrument is sensitive for both clinical- and sub-clinical levels of depressive symptoms, and have demonstrated favorable psychometric properties. A validated Norwegian version of the PHQ-9 is applied.

  7. Patient Health Questionnaire (PHQ-9; Norwegian version)

    Time frame: 12-months follow-up

    9-item self-report measure of depressive symptom severity. The recall period is 2 weeks. Response is given on a 4-point Likert scale (0: not at all, 1: several days, 2: more than half the days, and 3: nearly every day), resulting in the total score ranging from 0 to 27. Higher scores indicate higher symptom severity. The instrument is sensitive for both clinical- and sub-clinical levels of depressive symptoms, and have demonstrated favorable psychometric properties. A validated Norwegian version of the PHQ-9 is applied.

  8. Insomnia Severity Index (ISI; Norwegian version)

    Time frame: Post-treatment (10 - 13 weeks after trauma)

    7-item questionnaire, which measures insomnia symptoms during the past two weeks. The instrument utilizes a 5-point Likert scale ranging from 0 to 4, yielding a total score of 0-28. Higher scores indicate more insomnia symptoms. The ISI has demonstrated favorable psychometric properties. A Norwegian version of the ISI is applied.

  9. Insomnia Severity Index (ISI; Norwegian version)

    Time frame: 6-months follow-up

    7-item questionnaire, which measures insomnia symptoms during the past two weeks. The instrument utilizes a 5-point Likert scale ranging from 0 to 4, yielding a total score of 0-28. Higher scores indicate more insomnia symptoms. The ISI has demonstrated favorable psychometric properties. A Norwegian version of the ISI is applied.

  10. Insomnia Severity Index (ISI; Norwegian version)

    Time frame: 12-months follow-up

    7-item questionnaire, which measures insomnia symptoms during the past two weeks. The instrument utilizes a 5-point Likert scale ranging from 0 to 4, yielding a total score of 0-28. Higher scores indicate more insomnia symptoms. The ISI has demonstrated favorable psychometric properties. A Norwegian version of the ISI is applied.

  11. Client Satisfaction Questionnaire (CSQ-8; Norwegian version)

    Time frame: Post-treatment (10 - 13 weeks after trauma)

    Eight-item measure of participants' service satisfaction. Response is given on a scale ranging from one to four, with a resulting total score range from eight to 32. Higher scores suggest higher service satisfaction. A validated Norwegian version of the CSQ-8 will be applied.

  12. EQ-5D-5L (Norwegian version)

    Time frame: Post-treatment (10 - 13 weeks after trauma)

    Self-reported health-related quality of life. Self-care, mobility, pain/discomfort, usual activities, and anxiety/depression are measured on a 5-point scale. Response to each item is given by checking off one of five descriptions of functionality in that domain (e.g., have no problems doing my usual activities, slight problems, moderate problems, severe problems, or unable to do my usual activities). The total score ranges from 5 to 25, with higher scores indicating poorer health-related quality of life. Participant also rate their overall health on a scale from 1 (worst health) to 100 (best health). This scale is called the EQ VAS and is a part of the EQ-5D-5L. The instrument has demonstrated excellent psychometric properties. Recall period: today.

  13. EQ-5D-5L (Norwegian version)

    Time frame: 6-months follow-up

    Self-reported health-related quality of life. Self-care, mobility, pain/discomfort, usual activities, and anxiety/depression are measured on a 5-point scale. Response to each item is given by checking off one of five descriptions of functionality in that domain (e.g., have no problems doing my usual activities, slight problems, moderate problems, severe problems, or unable to do my usual activities). The total score ranges from 5 to 25, with higher scores indicating poorer health-related quality of life. Participant also rate their overall health on a scale from 1 (worst health) to 100 (best health). This scale is called the EQ VAS and is a part of the EQ-5D-5L. The instrument has demonstrated excellent psychometric properties. Recall period: today.

  14. EQ-5D-5L (Norwegian version)

    Time frame: 12-months follow-up

    Self-reported health-related quality of life. Self-care, mobility, pain/discomfort, usual activities, and anxiety/depression are measured on a 5-point scale. Response to each item is given by checking off one of five descriptions of functionality in that domain (e.g., have no problems doing my usual activities, slight problems, moderate problems, severe problems, or unable to do my usual activities). The total score ranges from 5 to 25, with higher scores indicating poorer health-related quality of life. Participant also rate their overall health on a scale from 1 (worst health) to 100 (best health). This scale is called the EQ VAS and is a part of the EQ-5D-5L. The instrument has demonstrated excellent psychometric properties. Recall period: today.

  15. The Recovering Quality of Life (ReQoL; Norwegian version)

    Time frame: Post-treatment (10 - 13 weeks after trauma)

    Validated 10-item self-report measure of quality of life specific to people with different mental health conditions. The total score ranges from 0 to 40, with lower scores indicating low quality of life. The scale has demonstrated excellent psychometric properties.

  16. The Recovering Quality of Life (ReQoL; Norwegian version)

    Time frame: 6-months follow-up

    Validated 10-item self-report measure of quality of life specific to people with different mental health conditions. The total score ranges from 0 to 40, with lower scores indicating low quality of life. The scale has demonstrated excellent psychometric properties.

  17. The Recovering Quality of Life (ReQoL; Norwegian version)

    Time frame: 12-months follow-up

    Validated 10-item self-report measure of quality of life specific to people with different mental health conditions. The total score ranges from 0 to 40, with lower scores indicating low quality of life. The scale has demonstrated excellent psychometric properties.

  18. Traumatic grief inventory self report, TGI-SR+

    Time frame: 12-months follow-up

    The TGI-SR+ is a 22-item self-report questionnaire to assess symptoms of DSM-5 persistent complex bereavement disorder (PCBD), and ICD-11 Prolonged grief disorder (PGD). Total score ranges from 22 to 110, with higher scores indicating more severe symptoms. The instrument has demonstrated good psychometric properties. Recall period: last month.

Other outcomes

  1. Mild-moderate adverse events questionnaire

    Time frame: Post-treatment (10 - 13 weeks after trauma)

    Severe adverse events are monitored and addressed continuously, and will be reported. Mild-moderate adverse events (AE) are reported on an unvalidated generic questionnaire, utilized in previous studies. Participants are asked to report experiences of AEs, and to describe the event briefly, report number of weeks after the traumatic event when the AE took place, frequency, and duration of the AE, and how the AE impacted quality of life when it occurred and today. The participants are also asked to report an appraisal of whether the AE was associated with receiving Condensed internet-delivered prolonged exposure (CIPE). Recall period: last 6 weeks.

  2. Self-reported work absence and use of health services

    Time frame: Post-treatment (10 weeks after trauma)

    Unvalidated questionnaire measuring job status, number of days on sick leave, annually household income, number of consultations with different types of health professionals, number of days admitted to inpatient psychiatric care, and psychotropic medication. Work absence and the type and quantity of services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 6 weeks (except annual income).

  3. Self-reported work absence and use of health services

    Time frame: 6-months follow-up

    Unvalidated questionnaire measuring job status, number of days on sick leave, annually household income, number of consultations with different types of health professionals, number of days admitted to inpatient psychiatric care, and psychotropic medication. Work absence and the type and quantity of services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 3,5 months (except annual income).

  4. Self-reported work absence and use of health services

    Time frame: 12-months follow-up

    Unvalidated questionnaire measuring job status, number of days on sick leave, annually household income, number of consultations with different types of health professionals, number of days admitted to inpatient psychiatric care, and psychotropic medication. Work absence and the type and quantity of services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 6 months (except annual income).

  5. Clinician-reported use of municipality health services

    Time frame: 2-months follow-up (2 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  6. Clinician-reported use of municipality health services

    Time frame: 3-months follow-up (3 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  7. Clinician-reported use of municipality health services

    Time frame: 4-months follow-up (4 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  8. Clinician-reported use of municipality health services

    Time frame: 5-months follow-up (5 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  9. Clinician-reported use of municipality health services

    Time frame: 6-months follow-up (6 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  10. Clinician-reported use of municipality health services

    Time frame: 7-months follow-up (7 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  11. Clinician-reported use of municipality health services

    Time frame: 8-months follow-up (8 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  12. Clinician-reported use of municipality health services

    Time frame: 9-months follow-up (9 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  13. Clinician-reported use of municipality health services

    Time frame: 10-months follow-up (10 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  14. Clinician-reported use of municipality health services

    Time frame: 11-months follow-up (11 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  15. Clinician-reported use of municipality health services

    Time frame: 12-months follow-up (12 months after trauma)

    Unvalidated questionnaire where clinicians in the municipality health services register date and place of consultation, type of health service, the clinician's profession, content, total minutes used, and any referral to other health services. Use of municipality health services will be transformed to reflect costs related to services used, using cost units from the corresponding financial years. Recall period: 1 month.

  16. Registry data on use of specialist health services

    Time frame: 12-months follow-up

    Registry data from the Norwegian Patient Registry (NPR) on referrals to specialist health services, date of consultation, type of consultation, diagnostic information.

  17. Registry data on use of health services

    Time frame: 12-months follow-up

    Registry data from municipality patient' and user registry (KPR) on consultations with general practitioners and acute health services, date of consultation, type of consultation, diagnostic information.

  18. Registry data on use of health service and work absence

    Time frame: 12-months follow-up

    Registry data on work absence/received social security (FD-Trygd).

Study contacts

Contact information is provided by the study sponsor or research team.

Harald Bækkelund, PhD

CONTACT

[email protected]

+47 90964268

Marianne S Birkeland, PhD

CONTACT

[email protected]

+47 41433496

Sponsors and collaborators

Lead sponsor

Norwegian Center for Violence and Traumatic Stress Studies

Other

Collaborators

  • Karolinska Institutet
  • NORCE Norwegian Research Centre AS
  • Regional Centre - Violence, Trauma and Suicide Prevention - Region East (RVTS-East)
  • The Research Council of Norway

Registry information

Acronym: EASE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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