Early Support After Exposure to Trauma

NCT ID: NCT06592677

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-traumatic Stress Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel two-armed multicenter add on randomized controlled trial.
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Condensed internet-delivered prolonged exposure (CIPE)

Intervention Type 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)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Treatment-as-usual (TAU)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regional Centre - Violence, Trauma and Suicide Prevention - Region East (RVTS-East)

UNKNOWN

Sponsor Role collaborator

NORCE Norwegian Research Centre AS

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role collaborator

The Research Council of Norway

OTHER

Sponsor Role collaborator

Norwegian Center for Violence and Traumatic Stress Studies

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Harald Bækkelund, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Center for Violence and Traumatic Stress Studies

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Asker municipality - Psychosocial crisis team

Asker, Asker, Norway

Site Status RECRUITING

Norwegian Center for Violence and Traumatic Stress Studies

Oslo, Oslo County, Norway

Site Status RECRUITING

Aurskog-Høland - Psychosocial crisis team

Bjørkelangen, , Norway

Site Status RECRUITING

Fredrikstad municipality - Psychosocial Crisis team

Fredrikstad, , Norway

Site Status RECRUITING

Gjøvik municipality - psychosocial crisis team

Gjøvik, , Norway

Site Status RECRUITING

Halden Municipality - psychosocial crisis team

Halden, , Norway

Site Status RECRUITING

Hamar Municipality - psychosocial crisis team

Hamar, , Norway

Site Status RECRUITING

Søndre Land municipality - psychosocial crisis team

Hov, , Norway

Site Status RECRUITING

Ullensaker municipality - psychosocial crisis team

Jessheim, , Norway

Site Status RECRUITING

Østre Toten municipality - Psychosocial crisis team

Lena, , Norway

Site Status RECRUITING

Psychosocial crisis team - Oslo, Bjerke

Oslo, , Norway

Site Status RECRUITING

Psychosocial crisis team - Oslo, Frogner

Oslo, , Norway

Site Status RECRUITING

Psychosocial crisis team - Oslo, gamle Oslo

Oslo, , Norway

Site Status RECRUITING

Psychosocial crisis team - Oslo, Grünerløkka

Oslo, , Norway

Site Status RECRUITING

Psychosocial crisis team - Oslo, Nordstrand

Oslo, , Norway

Site Status RECRUITING

Psychosocial crisis team - Oslo, Sagene

Oslo, , Norway

Site Status RECRUITING

Psychosocial crisis team - Oslo, Stovner

Oslo, , Norway

Site Status RECRUITING

Psychosocial emergency service - Oslo emergency room

Oslo, , Norway

Site Status RECRUITING

Ringsaker municipality - Psychosocial crisis team

Ringsaker, , Norway

Site Status RECRUITING

Gjerdrum - psychosocial crisis team

Sørum, , Norway

Site Status RECRUITING

Nannestad municipality - psychosocial crisis team

Teigebyen, , Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Harald Bækkelund, PhD

Role: CONTACT

+47 90964268

Marianne S Birkeland, PhD

Role: CONTACT

+47 41433496

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD

Role: primary

+4790964268

Espen R Lassen, Clinical psych., phd-candidate

Role: backup

+4791007573

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

Harald Bækkelund, PhD, clinical psych.

Role: primary

+4790964268

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26606250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35338915 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27098450 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34941354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28493729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35818021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33402149 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11438246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17040003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21532953 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36316661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33284428 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29433611 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34700189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37310324 (View on PubMed)

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

Reference Type BACKGROUND

Related Links

Access external resources that provide additional context or updates about the study.

https://www.helsedirektoratet.no/veiledere/psykososiale-tiltak-ved-kriser-ulykker-og-katastrofer

The Norwegian Directorate of Health. (2016). National guidelines for psychosocial support in the aftermath of crises and catastrophes

https://www.nkvts.no//content/uploads/2022/11/Traume-og-PTSD-screening-TRAPS-I.pdf

Heir, T. (2014). PCL-5. Norwegian centre for violence and traumatic stress studies.

https://www.nkvts.no//content/uploads/2018/03/KLINIKERADMINISTRERT-PTSD-SKALA-FOR-DSM-5-KAPS-5.pdf

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.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

302302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Enhancing Memory in CPT for PTSD
NCT06000475 RECRUITING NA