Clinical trial NCT06592677: Early Support After Exposure to Trauma
Official title: Early Support After Exposure to Trauma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: CIPE
PTSD
Indicated prevention
Prolonged Exposure
Lead sponsor: Norwegian Center for Violence and Traumatic Stress Studies
Sponsor class: OTHER
Collaborators: name: Regional Centre - Violence, Trauma and Suicide Prevention - Region East (RVTS-East)
name: NORCE Norwegian Research Centre AS
name: Karolinska Institutet
name: The Research Council of Norway
First posted: 2024-09-19
Enrollment: 360
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel two-armed multicenter add on randomized controlled trial.
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
timeFrame: Post-treatment (10 weeks after trauma)
Secondary outcomes:
measure: PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
timeFrame: 6 months follow-up
measure: PTSD Checklist for DSM-5 (PCL-5; Norwegian version)
timeFrame: 12 months follow-up
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)
timeFrame: 6-months follow-up
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)
timeFrame: 12-months follow-up
measure: Patient Health Questionnaire (PHQ-9; Norwegian version)
timeFrame: Post-treatment (10 weeks after trauma)
measure: Patient Health Questionnaire (PHQ-9; Norwegian version)
timeFrame: 6-months follow-up
measure: Patient Health Questionnaire (PHQ-9; Norwegian version)
timeFrame: 12-months follow-up
measure: Insomnia Severity Index (ISI; Norwegian version)
timeFrame: Post-treatment (10 weeks after trauma)
measure: Insomnia Severity Index (ISI; Norwegian version)
timeFrame: 6-months follow-up
measure: Insomnia Severity Index (ISI; Norwegian version)
timeFrame: 12-months follow-up
measure: Client Satisfaction Questionnaire (CSQ-8; Norwegian version)
timeFrame: Post-treatment (10 weeks after trauma)
measure: EQ-5D-5L (Norwegian version)
timeFrame: Post-treatment (10 weeks after trauma)
measure: EQ-5D-5L (Norwegian version)
timeFrame: 6-months follow-up
measure: EQ-5D-5L (Norwegian version)
timeFrame: 12-months follow-up
measure: The Recovering Quality of Life (ReQoL; Norwegian version)
timeFrame: Post-treatment (10 weeks after trauma)
measure: The Recovering Quality of Life (ReQoL; Norwegian version)
timeFrame: 6-months follow-up
measure: The Recovering Quality of Life (ReQoL; Norwegian version)
timeFrame: 12-months follow-up
measure: Traumatic grief inventory self report, TGI-SR+
timeFrame: 12-months follow-up
Other outcomes:
measure: Mild-moderate adverse events questionnaire
timeFrame: Post-treatment (10 weeks after trauma)
measure: Self-reported work absence and use of health services
timeFrame: Post-treatment (10 weeks after trauma)
measure: Self-reported work absence and use of health services
timeFrame: 6-months follow-up
measure: Self-reported work absence and use of health services
timeFrame: 12-months follow-up
measure: Clinician-reported use of municipality health services
timeFrame: 2-months follow-up (2 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 3-months follow-up (3 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 4-months follow-up (4 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 5-months follow-up (5 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 6-months follow-up (6 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 7-months follow-up (7 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 8-months follow-up (8 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 9-months follow-up (9 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 10-months follow-up (10 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 11-months follow-up (11 months after trauma)
measure: Clinician-reported use of municipality health services
timeFrame: 12-months follow-up (12 months after trauma)
measure: Registry data on use of specialist health services
timeFrame: 12-months follow-up
measure: Registry data on use of health services
timeFrame: 12-months follow-up
measure: Registry data on use of health service and work absence
timeFrame: 12-months follow-up
Locations:
city: Asker
country: Norway
facility: Asker municipality - Psychosocial crisis team
city: Bjørkelangen
country: Norway
facility: Aurskog-Høland - Psychosocial crisis team
city: Fredrikstad
country: Norway
facility: Fredrikstad municipality - Psychosocial Crisis team
city: Gjøvik
country: Norway
facility: Gjøvik municipality - psychosocial crisis team
city: Halden
country: Norway
facility: Halden Municipality - psychosocial crisis team
city: Hamar
country: Norway
facility: Hamar Municipality - psychosocial crisis team
city: Hov
country: Norway
facility: Søndre Land & Østre Toten municipalities - psychosocial crisis team
city: Jessheim
country: Norway
facility: Ullensaker municipality - psychosocial crisis team
city: Lena
country: Norway
facility: Østre Toten municipality - Psychosocial crisis team
city: Oslo
country: Norway
facility: Norwegian Center for Violence and Traumatic Stress Studies
city: Oslo
country: Norway
facility: Psychosocial crisis team - Oslo, Bjerke
city: Oslo
country: Norway
facility: Psychosocial crisis team - Oslo, Frogner
city: Oslo
country: Norway
facility: Psychosocial crisis team - Oslo, gamle Oslo
city: Oslo
country: Norway
facility: Psychosocial crisis team - Oslo, Grünerløkka
city: Oslo
country: Norway
facility: Psychosocial crisis team - Oslo, Nordstrand
city: Oslo
country: Norway
facility: Psychosocial crisis team - Oslo, Sagene
city: Oslo
country: Norway
facility: Psychosocial crisis team - Oslo, Stovner
city: Oslo
country: Norway
facility: Psychosocial emergency service - Oslo emergency room
city: Ringsaker
country: Norway
facility: Ringsaker municipality - Psychosocial crisis team
city: Sørum
country: Norway
facility: Gjerdrum - psychosocial crisis team
city: Teigebyen
country: Norway
facility: Nannestad municipality - psychosocial crisis team
Study officials:
affiliation: Norwegian Center for Violence and Traumatic Stress Studies
name: Harald Bækkelund, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). https://doi.org/10.1176/appi.books.9780890425596