Early Support After Exposure to Trauma

Overview

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).

Interventions

• 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.

Primary outcome measures

• PTSD Checklist for DSM-5 (PCL-5; Norwegian version) [Time frame: Post-treatment (10 - 13 weeks after trauma)]

Secondary outcome measures (12)

• PTSD Checklist for DSM-5 (PCL-5; Norwegian version) [Time frame: 6 months follow-up]
• PTSD Checklist for DSM-5 (PCL-5; Norwegian version) [Time frame: 12 months follow-up]
• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version) [Time frame: 6-months follow-up]
• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version) [Time frame: 12-months follow-up]
• Patient Health Questionnaire (PHQ-9; Norwegian version) [Time frame: Post-treatment (10 - 13 weeks after trauma)]
• Patient Health Questionnaire (PHQ-9; Norwegian version) [Time frame: 6-months follow-up]
• Patient Health Questionnaire (PHQ-9; Norwegian version) [Time frame: 12-months follow-up]
• Insomnia Severity Index (ISI; Norwegian version) [Time frame: Post-treatment (10 - 13 weeks after trauma)]
• Insomnia Severity Index (ISI; Norwegian version) [Time frame: 6-months follow-up]
• Insomnia Severity Index (ISI; Norwegian version) [Time frame: 12-months follow-up]
• Client Satisfaction Questionnaire (CSQ-8; Norwegian version) [Time frame: Post-treatment (10 - 13 weeks after trauma)]
• EQ-5D-5L (Norwegian version) [Time frame: Post-treatment (10 - 13 weeks after trauma)]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Norway · 29 centers

• Asker municipality - Psychosocial crisis team — Asker
• Psychosocial crisis team - Indre Østfold kommune — Askim
• Psychosocial crisis team - Oslo, St Hanshaugen — Oslo
• Psychosocial crisis team - Oslo, Ullern — Oslo
• Norwegian Center for Violence and Traumatic Stress Studies — Oslo
• Psychosocial crisis team - Oslo, Nordre Aker — Oslo
• Psychosocial crisis team - Oslo, Østensjø — Oslo
• Psychosocial crisis team - Oslo, Vestre Aker — Oslo
• … and 21 more centers

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06592677 · 302302

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗