Ignite Creation Date:
2024-10-26 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502106
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Internet-delivered Trauma-focused Cognitive-behavioral Therapy as an Early Intervention After Sexual Trauma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
The research aims to assess the practicality and implementation aspects effectiveness and processes of change related to Condensed Internet-delivered Prolonged Exposure CIPE administered as an early trauma focused intervention after sexual assault Eligible participants are individuals seeking help at Traumamottagning Centrum för Sexuell Hälsa Malmö who have been exposed to sexual assualt in the past two months and exhibit psychological symptoms in response to that
Detailed Description:
The study is un-controlled with 30 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 level of symptoms of post traumatic stress rated by the PCL-5 Secondary outcomes are level of symptoms of post traumatic stress using the Clinician Administered PTSD Scale version 5 CAPS-5 and The International Trauma Questionnaire ITQ level of depression PHQ-9 quality of life WSAS and EQ-5D dropout rate rates of inclusion attrition adherenceand negative effects
Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants views on the treatment preferences for this type of treatment and how to further improve it
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 for sexual assault at Traumamottagning Centrum för Sexuell Hälsa Malmö
Qualitative data using a semi-structured interview will be gathered from participants at the end of the treatment collecting data on participants views on the treatment preferences for this type of treatment and how to further improve it
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 for sexual assault at Traumamottagning Centrum för Sexuell Hälsa Malmö
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