An interventional study of Condensed internet-delivered prolonged exposure (CIPE) and Treatment-as-usual (TAU) in Post-traumatic Stress Disorder, sponsored by Norwegian Center for Violence and Traumatic Stress Studies. Recruiting at 29 sites in Norway. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by Norwegian Center for Violence and Traumatic Stress Studies · Not applicable, Interventional, and Prevention
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).
2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.
This study's planned enrollment of 360 is above the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →Norwegian Center for Violence and Traumatic Stress Studies is the lead sponsor of 13 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Condensed internet-delivered prolonged exposure (CIPE) · Behavioral: Treatment-as-usual (TAU)
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.
Behavioral: Treatment-as-usual (TAU)
'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.
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.
PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
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.
Time frame: Post-treatment (10 - 13 weeks after trauma)
PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
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.
Time frame: 6 months follow-up
PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
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.
Time frame: 12 months follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)
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.
Time frame: 6-months follow-up
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)
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.
Time frame: 12-months follow-up
Patient Health Questionnaire (PHQ-9; Norwegian version)
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.
Time frame: Post-treatment (10 - 13 weeks after trauma)
Patient Health Questionnaire (PHQ-9; Norwegian version)
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.
Time frame: 6-months follow-up
Patient Health Questionnaire (PHQ-9; Norwegian version)
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.
Time frame: 12-months follow-up
Insomnia Severity Index (ISI; Norwegian version)
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.
Time frame: Post-treatment (10 - 13 weeks after trauma)
Insomnia Severity Index (ISI; Norwegian version)
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.
Time frame: 6-months follow-up
Insomnia Severity Index (ISI; Norwegian version)
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.
Time frame: 12-months follow-up
Client Satisfaction Questionnaire (CSQ-8; Norwegian version)
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.
Time frame: Post-treatment (10 - 13 weeks after trauma)
EQ-5D-5L (Norwegian version)
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.
Time frame: Post-treatment (10 - 13 weeks after trauma)
EQ-5D-5L (Norwegian version)
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.
Time frame: 6-months follow-up
EQ-5D-5L (Norwegian version)
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.
Time frame: 12-months follow-up
The Recovering Quality of Life (ReQoL; Norwegian version)
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.
Time frame: Post-treatment (10 - 13 weeks after trauma)
The Recovering Quality of Life (ReQoL; Norwegian version)
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.
Time frame: 6-months follow-up
The Recovering Quality of Life (ReQoL; Norwegian version)
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.
Time frame: 12-months follow-up
Traumatic grief inventory self report, TGI-SR+
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.
Time frame: 12-months follow-up
Mild-moderate adverse events questionnaire
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.
Time frame: Post-treatment (10 - 13 weeks after trauma)
Self-reported work absence and use of health services
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).
Time frame: Post-treatment (10 weeks after trauma)
Self-reported work absence and use of health services
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).
Time frame: 6-months follow-up
Self-reported work absence and use of health services
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).
Time frame: 12-months follow-up
Clinician-reported use of municipality health services
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.
Time frame: 2-months follow-up (2 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 3-months follow-up (3 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 4-months follow-up (4 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 5-months follow-up (5 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 6-months follow-up (6 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 7-months follow-up (7 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 8-months follow-up (8 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 9-months follow-up (9 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 10-months follow-up (10 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 11-months follow-up (11 months after trauma)
Clinician-reported use of municipality health services
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.
Time frame: 12-months follow-up (12 months after trauma)
Registry data on use of specialist health services
Registry data from the Norwegian Patient Registry (NPR) on referrals to specialist health services, date of consultation, type of consultation, diagnostic information.
Time frame: 12-months follow-up
Registry data on use of health services
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.
Time frame: 12-months follow-up
Registry data on use of health service and work absence
Registry data on work absence/received social security (FD-Trygd).
Time frame: 12-months follow-up
Plan to share: Yes — Anonymized individual participant outcome- and background data, and code generated from the project, will be made available upon reasonable request, to the degree permitted by ethical board approval.
Supporting information: Study protocol, Analytic code
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Stress Disorders, Post-Traumatic→
Norwegian Center for Violence and Traumatic Stress Studies