Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318195
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-03-12
Brief Title:
Condensed Digital Prolonged Exposure for Individuals Treated Within Somatic Trauma Care
Sponsor:
Karolinska Institutet
Organization:
Karolinska Institutet
Study Overview
Official Title:
Internet Delivered Condensed Cognitive Behavioral Treatment Prolonged Exposure for Individuals Treated Within Somatic Trauma Care
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CiPE
Brief Summary:
The purpose of the study is to investigate the feasibility of implementation aspects treatment effects and change processes regarding a brief trauma-focused Internet-based CBT treatment for patients who have been treated in trauma care at Karolinska University Hospital and who exhibit symptoms of psychological consequences of the traumatic event Another aim is to explore factors predictors moderators and mediators that influence the effect of the treatment in order to better understand who responds to the treatment
Detailed Description:
The study is un-controlled with 250 participants that will undergo a brief trauma-focused Internet-based CBT treatment delivered as a three-week treatment comprising of four modules psychoeducationrational in vivo exposure imaginal exposure and relapse prevention The primary outcome is the PCL-5 Secondary outcomes are level of depression PHQ-9 quality of life WSAS and predictors moderators and mediators of clinically meaningful change in symptoms dropout rate rates of inclusion attrition adherenceand negative effects
Self-reported qualitative data from participants will be gathered at treatment completion to capture participants experiences of participating in the intervention as well as their views on how to further improve the intervention The treatment effects will be evaluated using a within-group design with repeated measurements Participants in the study will be will recruited from patients treated in the somatic trauma care at the Karolinska University Hospital in Stockholm Sweden
Self-reported qualitative data from participants will be gathered at treatment completion to capture participants experiences of participating in the intervention as well as their views on how to further improve the intervention The treatment effects will be evaluated using a within-group design with repeated measurements Participants in the study will be will recruited from patients treated in the somatic trauma care at the Karolinska University Hospital in Stockholm Sweden
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None