Early Support After Exposure to Trauma (EASE)

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).

Study Overview

• Status: Recruiting
• Conditions: Post-traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Condensed internet-delivered prolonged exposure (CIPE); Behavioral: Treatment-as-usual (TAU)

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Harald Bækkelund, PhD; Phone Number: +47 90964268; Email: harald.bakkelund@nkvts.no
• Study Contact Backup: Name: Marianne S Birkeland, PhD; Phone Number: +47 41433496; Email: m.s.birkeland@nkvts.no

Study Locations

• Norway
  • Bjørkelangen, Norway
    • Recruiting
    • Aurskog-Høland - Psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Fredrikstad, Norway
    • Recruiting
    • Fredrikstad municipality - Psychosocial Crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Gjøvik, Norway
    • Recruiting
    • Gjøvik municipality - psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Halden, Norway
    • Recruiting
    • Halden Municipality - psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Hamar, Norway
    • Recruiting
    • Hamar Municipality - psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Hov, Norway
    • Recruiting
    • Søndre Land municipality - psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Jessheim, Norway
    • Recruiting
    • Ullensaker municipality - psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial crisis team - Oslo, Bjerke
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial crisis team - Oslo, Frogner
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial crisis team - Oslo, gamle Oslo
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial crisis team - Oslo, Grünerløkka
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial crisis team - Oslo, Nordstrand
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial crisis team - Oslo, Sagene
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial crisis team - Oslo, Stovner
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo, Norway
    • Recruiting
    • Psychosocial emergency service - Oslo emergency room
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Ringsaker, Norway
    • Recruiting
    • Ringsaker municipality - Psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Sørum, Norway
    • Recruiting
    • Gjerdrum - psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Teigebyen, Norway
    • Recruiting
    • Nannestad municipality - psychosocial crisis team
    • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Asker
    • Asker, Asker, Norway, 1384
      • Recruiting
      • Asker municipality - Psychosocial crisis team
      • Contact: Harald Bækkelund, PhD, clinical psych.; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Askim
    • Askim, Askim, Norway, 1830
      • Recruiting
      • Psychosocial crisis team - Indre Østfold kommune
      • Contact: Harald Bækkelund, D.Clin.Psych, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
  • Oslo County
    • Oslo, Oslo County, Norway, 0484
      • Recruiting
      • Norwegian Center for Violence and Traumatic Stress Studies
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
      • Contact: Espen R Lassen, Clinical psych., phd-candidate; Phone Number: +4791007573
    • Oslo, Oslo County, Norway, 0170
      • Recruiting
      • Psychosocial crisis team - Oslo, St Hanshaugen
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
    • Oslo, Oslo County, Norway, 0377
      • Recruiting
      • Psychosocial crisis team - Oslo, Ullern
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
    • Oslo, Oslo County, Norway, 0484
      • Recruiting
      • Psychosocial crisis team - Oslo, Nordre Aker
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
    • Oslo, Oslo County, Norway, 0694
      • Recruiting
      • Psychosocial crisis team - Oslo, Østensjø
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
    • Oslo, Oslo County, Norway, 0754
      • Recruiting
      • Psychosocial crisis team - Oslo, Vestre Aker
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
    • Oslo, Oslo County, Norway, 0954
      • Recruiting
      • Psychosocial crisis team - Oslo, Grorud
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
    • Oslo, Oslo County, Norway, 1051
      • Recruiting
      • Psychosocial crisis team - Oslo, Alna
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no
    • Oslo, Oslo County, Norway, 1203
      • Recruiting
      • Psychosocial crisis team - Oslo, Søndre Nordstrand
      • Contact: Harald Bækkelund, PhD; Phone Number: +4790964268; Email: harald.bakkelund@nkvts.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Condensed internet-delivered prolonged exposure (CIPE) + Treatment-as-usual (TAU); 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); '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.
Active Comparator: Treatment-as-usual (TAU) only; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-treatment (10 - 13 weeks after trauma)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	12-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.	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.	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.	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.	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.	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.	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.	Post-treatment (10 - 13 weeks after trauma)
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.	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.	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.	Post-treatment (10 - 13 weeks after trauma)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	12-months follow-up
Registry data on use of health service and work absence	Registry data on work absence/received social security (FD-Trygd).	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.	Post-treatment (10 - 13 weeks after trauma)

Collaborators and Investigators

• Sponsor: Norwegian Center for Violence and Traumatic Stress Studies
• Collaborators: Karolinska Institutet; The Research Council of Norway; NORCE Norwegian Research Centre AS; Regional Centre - Violence, Trauma and Suicide Prevention - Region East (RVTS-East)
• Investigators: Principal Investigator: Harald Bækkelund, PhD, Norwegian Center for Violence and Traumatic Stress Studies

Publications and helpful links

General Publications

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Helpful Links

• The Norwegian Directorate of Health. (2016). National guidelines for psychosocial support in the aftermath of crises and catastrophes
• Heir, T. (2014). PCL-5. Norwegian centre for violence and traumatic stress studies.
• Bækkelund, H., Aareskjold, J., & Endsjø, M. (2015). KLINIKERADMINISTRERT PTSD-SKALA FOR DSM-5: Versjon for vurdering av siste måned. Norwegian Centre for Violence and Traumatic Stress Studies.

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: September 10, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: PTSD; Prolonged Exposure; Indicated prevention; CIPE
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 302302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning six months and ending 5 years following article production.
• IPD Sharing Access Criteria: Researchers with a methodologically sound proposal. Proposals should be directed to PI.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No