Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06592677
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Early Support After Exposure to Trauma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early Support After Exposure to Trauma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASE
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 25- 6- and 12- months after the traumatic incident
H2 Significantly fewer participants receiving CIPETAU will fulfill the criteria for PTSD than participants receiving TAU at 6- and 12-months post trauma
H3 Participants receiving CIPETAU will have significantly less symptoms of depression and insomnia than participants receiving TAU at 25- 6- and 12- months after the traumatic incident
H4 Participants in the CIPETAU-condition will report significantly higher treatment satisfaction at post-treatment compared to those in the TAU-condition
H5 Participants with traumatic loss receiving CIPETAU 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 CIPETAU-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 CIPETAU implementation is more cost-effective compared to the TAU in the short run and may even dominate TAU in the long run ie more effective and less costly
Hypotheses Effectiveness H1 Participants receiving CIPE treatment as usual TAU will have significantly less PTSS than participants receiving TAU at 25- 6- and 12- months after the traumatic incident
H2 Significantly fewer participants receiving CIPETAU will fulfill the criteria for PTSD than participants receiving TAU at 6- and 12-months post trauma
H3 Participants receiving CIPETAU will have significantly less symptoms of depression and insomnia than participants receiving TAU at 25- 6- and 12- months after the traumatic incident
H4 Participants in the CIPETAU-condition will report significantly higher treatment satisfaction at post-treatment compared to those in the TAU-condition
H5 Participants with traumatic loss receiving CIPETAU 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 CIPETAU-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 CIPETAU implementation is more cost-effective compared to the TAU in the short run and may even dominate TAU in the long run ie more effective and less costly
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None