Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06571513
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Written Exposure Therapy to Improve Recovery Among Sexual Assault Survivors
Status:
RECRUITING
Status Verified Date:
2024-10
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 main objective of this pilot trial is to determine the feasibility and initial efficacy of telehealth-delivered written exposure therapy to reduce the development of posttraumatic stress disorder after sexual assault This pilot trial will provide the data necessary to design and support a large-scale trial
Detailed Description:
Each year approximately 100000 women in the United States present to sexual assault nurse examiner SANE programs for evaluation after experiencing sexual assault A wealth of data demonstrates that the development of adverse posttraumatic neuropsychiatric sequelae such as posttraumatic stress disorder PTSD is common in this population and that individuals with a history of traumatic stress exposure andor posttraumatic stress symptoms are at increased risk Unfortunately no secondary preventive interventions are currently widely available that can prevent PTSD among those at high risk Moreover the 10 of sexual assault survivors in the United States who live in rural communities face even greater barriers to obtaining care Written exposure therapy is an evidence-based low-cost intervention that has demonstrated efficacy in treating chronic PTSD symptoms after a variety of traumatic stress exposures including sexual assault In addition telehealth delivery of written exposure therapy for PTSD has yielded similar treatment outcomes and lower attrition compared to in-person delivery The present protocol will assess the feasibility and preliminary efficacy of telehealth-delivered written exposure therapy as a secondary preventive intervention for sexual assault survivors in the acute aftermath of trauma exposure This pilot trial will randomize N80 women who received SANE care following sexual assault to five sessions of either virtual written exposure therapy n40 or virtual unemotional writing control n40 The same experienced therapists will deliver both interventions via telehealthvideo sessions Participant follow-ups will be performed remotely via REDCap self-report surveys by trained assessors and research associates Results of this trial will demonstrate the feasibility and potential efficacy of written exposure therapy to reduce the development of PTSD after sexual assault and will provide the data necessary to design and support a large-scale trial
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