Early Support After Exposure to Trauma

Not Applicable

Recruiting

• Conditions: Post-traumatic Stress Disorder

• Registration Number: NCT06592677
• Lead Sponsor: Norwegian Center for Violence and Traumatic Stress Studies

Brief Summary

A significant proportion of people who are exposed to traumatic events suffer from post-traumatic sequelae, such as post-traumatic stress disorder (PTSD). Indicated preventive interventions soon after trauma could be appropriate. Yet, there is limited evidence for the efficacy of such interventions. Moreover, no evidence-based preventive interventions are readily available for victims in the aftermath of crises and disasters in Norway. Condensed Internet-delivered Prolonged Exposure (CIPE) is a preventive intervention designed for victims with symptoms of PTSD (PTSS) approximately one month after a traumatic event. The treatment is an internet-delivered, therapist assisted intervention, based on principles from Prolonged Exposure. CIPE has proven to be feasible, safe, and effective in previous studies. This study aims to test the effectiveness and cost-effectiveness of CIPE in the context of psychosocial crisis services in Norwegian municipalities.

Hypotheses Effectiveness H1 Participants receiving CIPE + treatment as usual (TAU) will have significantly less PTSS than participants receiving TAU at 2.5-, 6-, and 12- months after the traumatic incident.

H2 Significantly fewer participants receiving CIPE+TAU will fulfill the criteria for PTSD than 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 2.5-, 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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-29
• Study First Submitted QC: 2024-09-10
• Study Start: 2024-09-13
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-26
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

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 month 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5; Norwegian version)	Post-treatment (10 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 Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-5 (PCL-5; Norwegian version)	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.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)	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.
Patient Health Questionnaire (PHQ-9; Norwegian version)	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.
Insomnia Severity Index (ISI; Norwegian version)	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.
Client Satisfaction Questionnaire (CSQ-8; Norwegian version)	Post-treatment (10 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.
EQ-5D-5L (Norwegian version)	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.
The Recovering Quality of Life (ReQoL; Norwegian version)	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.
Traumatic grief inventory self report, TGI-SR+	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.

Trial Locations

Locations (21)

Asker municipality - Psychosocial crisis team; 🇳🇴 Asker, Norway

Aurskog-Høland - Psychosocial crisis team; 🇳🇴 Bjørkelangen, Norway

Fredrikstad municipality - Psychosocial Crisis team; 🇳🇴 Fredrikstad, Norway

Gjøvik municipality - psychosocial crisis team; 🇳🇴 Gjøvik, Norway

Halden Municipality - psychosocial crisis team; 🇳🇴 Halden, Norway

Hamar Municipality - psychosocial crisis team; 🇳🇴 Hamar, Norway

Søndre Land & Østre Toten municipalities - psychosocial crisis team; 🇳🇴 Hov, Norway

Ullensaker municipality - psychosocial crisis team; 🇳🇴 Jessheim, Norway

Østre Toten municipality - Psychosocial crisis team; 🇳🇴 Lena, Norway

Norwegian Center for Violence and Traumatic Stress Studies; 🇳🇴 Oslo, Norway

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