Early Support After Exposure to Trauma

NCT06592677 | Recruiting DMC

• 1 other identifier: 302302
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 29

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 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).

Conditions

Post-traumatic Stress Disorder

Keywords

CIPE; PTSD; Indicated prevention; Prolonged Exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

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

  6 months follow-up

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

  12 months follow-up

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

  6-months follow-up

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

  12-months follow-up

• Patient Health Questionnaire (PHQ-9; Norwegian version)

  Post-treatment (10 - 13 weeks after trauma)

Other Outcomes (18)

• Mild-moderate adverse events questionnaire

  Post-treatment (10 - 13 weeks after trauma)

• Self-reported work absence and use of health services

  Post-treatment (10 weeks after trauma)

• Self-reported work absence and use of health services

  6-months follow-up

Study Arms (2)

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

EXPERIMENTAL

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)

Treatment-as-usual (TAU) only

ACTIVE COMPARATOR

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)

Interventions

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.

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

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.

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

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NORCE Norwegian Research Centre AS: collaborator
• Karolinska Institutet: collaborator
• The Research Council of Norway: collaborator
• Norwegian Center for Violence and Traumatic Stress Studies: lead
• Regional Centre - Violence, Trauma and Suicide Prevention - Region East (RVTS-East): collaborator

Study Sites (29)

Asker municipality - Psychosocial crisis team

Asker, Asker, 1384, Norway

RECRUITING

Psychosocial crisis team - Indre Østfold kommune

Askim, Askim, 1830, Norway

RECRUITING

Psychosocial crisis team - Oslo, St Hanshaugen

Oslo, Oslo County, 0170, Norway

RECRUITING

Psychosocial crisis team - Oslo, Ullern

Oslo, Oslo County, 0377, Norway

RECRUITING

Norwegian Center for Violence and Traumatic Stress Studies

Oslo, Oslo County, 0484, Norway

RECRUITING

Psychosocial crisis team - Oslo, Nordre Aker

Oslo, Oslo County, 0484, Norway

RECRUITING

Psychosocial crisis team - Oslo, Østensjø

Oslo, Oslo County, 0694, Norway

RECRUITING

Psychosocial crisis team - Oslo, Vestre Aker

Oslo, Oslo County, 0754, Norway

RECRUITING

Psychosocial crisis team - Oslo, Grorud

Oslo, Oslo County, 0954, Norway

RECRUITING

Psychosocial crisis team - Oslo, Alna

Oslo, Oslo County, 1051, Norway

RECRUITING

Psychosocial crisis team - Oslo, Søndre Nordstrand

Oslo, Oslo County, 1203, Norway

RECRUITING

Aurskog-Høland - Psychosocial crisis team

Bjørkelangen, Norway

RECRUITING

Fredrikstad municipality - Psychosocial Crisis team

Fredrikstad, Norway

RECRUITING

Gjøvik municipality - psychosocial crisis team

Gjøvik, Norway

RECRUITING

Halden Municipality - psychosocial crisis team

Halden, Norway

RECRUITING

Hamar Municipality - psychosocial crisis team

Hamar, Norway

RECRUITING

Søndre Land municipality - psychosocial crisis team

Hov, Norway

RECRUITING

Ullensaker municipality - psychosocial crisis team

Jessheim, Norway

RECRUITING

Psychosocial crisis team - Oslo, Bjerke

Oslo, Norway

RECRUITING

Psychosocial crisis team - Oslo, Frogner

Oslo, Norway

RECRUITING

Psychosocial crisis team - Oslo, gamle Oslo

Oslo, Norway

RECRUITING

Psychosocial crisis team - Oslo, Grünerløkka

Oslo, Norway

RECRUITING

Psychosocial crisis team - Oslo, Nordstrand

Oslo, Norway

RECRUITING

Psychosocial crisis team - Oslo, Sagene

Oslo, Norway

RECRUITING

Psychosocial crisis team - Oslo, Stovner

Oslo, Norway

RECRUITING

Psychosocial emergency service - Oslo emergency room

Oslo, Norway

RECRUITING

Ringsaker municipality - Psychosocial crisis team

Ringsaker, Norway

RECRUITING

Gjerdrum - psychosocial crisis team

Sørum, Norway

RECRUITING

Nannestad municipality - psychosocial crisis team

Teigebyen, Norway

RECRUITING

Related Publications (18)

• Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

  PMID: 26606250 BACKGROUND

• Mekawi Y, Silverstein MW, Walker A, Ishiekwene M, Carter S, Michopoulos V, Stevens JS, Powers A. Examining the psychometric properties of the PCL-5 in a black community sample using item response theory. J Anxiety Disord. 2022 Apr;87:102555. doi: 10.1016/j.janxdis.2022.102555. Epub 2022 Mar 10.

  PMID: 35338915 BACKGROUND

• Sveen J, Bondjers K, Willebrand M. Psychometric properties of the PTSD Checklist for DSM-5: a pilot study. Eur J Psychotraumatol. 2016 Apr 19;7:30165. doi: 10.3402/ejpt.v7.30165. eCollection 2016.

  PMID: 27098450 BACKGROUND

• Marx BP, Lee DJ, Norman SB, Bovin MJ, Sloan DM, Weathers FW, Keane TM, Schnurr PP. Reliable and clinically significant change in the clinician-administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 among male veterans. Psychol Assess. 2022 Feb;34(2):197-203. doi: 10.1037/pas0001098. Epub 2021 Dec 23.

  PMID: 34941354 BACKGROUND

• Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.

  PMID: 28493729 BACKGROUND

• Brattmyr M, Lindberg MS, Solem S, Hjemdal O, Havnen A. Factor structure, measurement invariance, and concurrent validity of the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder scale-7 in a Norwegian psychiatric outpatient sample. BMC Psychiatry. 2022 Jul 11;22(1):461. doi: 10.1186/s12888-022-04101-z.

  PMID: 35818021 BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Wisting L, Johnson SU, Bulik CM, Andreassen OA, Ro O, Bang L. Psychometric properties of the Norwegian version of the Patient Health Questionnaire-9 (PHQ-9) in a large female sample of adults with and without eating disorders. BMC Psychiatry. 2021 Jan 5;21(1):6. doi: 10.1186/s12888-020-03013-0.

  PMID: 33402149 BACKGROUND

• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

  PMID: 11438246 BACKGROUND

• Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. doi: 10.1093/sleep/29.9.1155.

  PMID: 17040003 BACKGROUND

• Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

  PMID: 21532953 BACKGROUND

• Pedersen H, Havnen A, Brattmyr M, Attkisson CC, Lara-Cabrera ML. A digital Norwegian version of the client satisfaction questionnaire 8: factor validity and internal reliability in outpatient mental health care. BMC Psychiatry. 2022 Oct 31;22(1):671. doi: 10.1186/s12888-022-04281-8.

  PMID: 36316661 BACKGROUND

• Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.

  PMID: 33284428 BACKGROUND

• Keetharuth AD, Brazier J, Connell J, Bjorner JB, Carlton J, Taylor Buck E, Ricketts T, McKendrick K, Browne J, Croudace T, Barkham M. Recovering Quality of Life (ReQoL): a new generic self-reported outcome measure for use with people experiencing mental health difficulties. Br J Psychiatry. 2018 Jan;212(1):42-49. doi: 10.1192/bjp.2017.10.

  PMID: 29433611 BACKGROUND

• Lenferink LIM, Eisma MC, Smid GE, de Keijser J, Boelen PA. Valid measurement of DSM-5 persistent complex bereavement disorder and DSM-5-TR and ICD-11 prolonged grief disorder: The Traumatic Grief Inventory-Self Report Plus (TGI-SR+). Compr Psychiatry. 2022 Jan;112:152281. doi: 10.1016/j.comppsych.2021.152281. Epub 2021 Oct 21.

  PMID: 34700189 BACKGROUND

• Bragesjo M, Arnberg FK, Olofsdotter Lauri K, Aspvall K, Sarnholm J, Andersson E. Condensed Internet-delivered prolonged exposure provided soon after trauma: a randomised trial. Psychol Med. 2023 Apr;53(5):1989-1998. doi: 10.1017/S0033291721003706. Epub 2021 Sep 14.

  PMID: 37310324 BACKGROUND

• American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596

  BACKGROUND

• Lassen ER, Birkeland MS, Egeland K, Stene LE, Brodersen D, Ekornas B, Reinholdt NP, Kjerstad E, Lamu AN, Aarons GA, Crable EL, Bragesjo M, Baekkelund H. Early Support after Exposure to Trauma (EASE): protocol for a hybrid effectiveness-implementation trial of an internet-based intervention for PTSD prevention. Trials. 2026 Feb 5;27(1):196. doi: 10.1186/s13063-026-09502-z.

  PMID: 41645255 DERIVED

Related 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.

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Harald Bækkelund, PhD

  Norwegian Center for Violence and Traumatic Stress Studies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Harald Bækkelund, PhD

CONTACT

+47 90964268; harald.bakkelund@nkvts.no

Marianne S Birkeland, PhD

CONTACT

+47 41433496; m.s.birkeland@nkvts.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator: senior statistician will be blinded for condition. Junior statistician will not, due to practical barriers (double role as the study coordinator). The person responsible for randomization will be blinded for the outcome of the screening (T0) and baseline (T1) assessments. Outcome assessors: graduate psychology students who will perform the clinical interviews will be blinded for condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel two-armed multicenter add on randomized controlled trial.

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: September 19, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Beginning six months and ending 5 years following article production.
• Access Criteria: Researchers with a methodologically sound proposal. Proposals should be directed to PI.

Locations

NO (29)