Ignite Creation Date:
2024-05-06 @ 10:19 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03229525
Status:
UNKNOWN
Last Update Posted:
2019-12-13
First Post:
2017-07-19
Brief Title:
Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder
Sponsor:
University of Texas at Austin
Organization:
University of Texas at Austin
Study Overview
Official Title:
Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
RECRUITING
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:
None
Brief Summary:
Post-traumatic Stress Disorder PTSD is a debilitating mental disorder that affects approximately 7 of the general population This projects aim is to develop a greater understanding of the efficacy and underlying mechanisms of narrative exposure based treatments for PTSD Adult participants N162 who meet DSM-5 criteria for PTSD will be enrolled in a 3-arm randomized clinical trial consisting of trauma-related expressive writing trauma-related expressive speaking or a factual expressive writing control condition Treatments will be manualized and conducted entirely through the Qualtrics survey platform Treatment will consist of six sessions three per week over two weeks taking place via the internet Assessments will be conducted pre-treatment post-treatment and at 1-month follow-up in the lab Assessments will be comprised of symptom self-report measures as well as two tasks completed in an eye tracker a reading task to evaluate mechanisms underlying trauma narrative processing and a sentence production task to evaluate attentional shifts when producing verbal information
Specific Aims and Hypotheses
1 Develop and test the relative efficacy of two cost-effective internet-based expressive trauma therapies written vs spoken relative to a non-trauma writing control for PTSD We hypothesize that both trauma-focused expressive therapies will achieve more favorable outcomes at posttreatment and follow-up on measures of PTSD and depression symptoms posttraumatic growth and quality of life compared to the writing control
2 Conduct exploratory analyses testing baseline PTSD severity depression severity trauma type time since trauma and emotional engagement in moderating the differential effects of the selected expressive therapies
3 Test the moderation of 1 active language processing with eye tracking ie how long certain words are fixated on 2 selected linguistic elements ie frequency of emotional words frequency of the pronoun I 3 perceived self-efficacy to cope with trauma memories 4 perceived threat appraisals associated with intrusive trauma memories on treatment outcome at follow-up We hypothesize that 1 fewer and shorter fixations on ideographic ie personally relevant trauma words when reading the trauma narrative in the eye tracker will be associated with reductions in PTSD symptoms at follow-up 2 increased use of emotional words over the course of writing sessions will be associated with reductions in PTSD and depression symptoms at follow-up 3 pre- to posttreatment increases in trauma memory acceptance self-efficacy and 4 pre- to posttreatment reductions in trauma memory threat appraisals will be associated with greater symptom reduction at the follow-up assessment
Specific Aims and Hypotheses
1 Develop and test the relative efficacy of two cost-effective internet-based expressive trauma therapies written vs spoken relative to a non-trauma writing control for PTSD We hypothesize that both trauma-focused expressive therapies will achieve more favorable outcomes at posttreatment and follow-up on measures of PTSD and depression symptoms posttraumatic growth and quality of life compared to the writing control
2 Conduct exploratory analyses testing baseline PTSD severity depression severity trauma type time since trauma and emotional engagement in moderating the differential effects of the selected expressive therapies
3 Test the moderation of 1 active language processing with eye tracking ie how long certain words are fixated on 2 selected linguistic elements ie frequency of emotional words frequency of the pronoun I 3 perceived self-efficacy to cope with trauma memories 4 perceived threat appraisals associated with intrusive trauma memories on treatment outcome at follow-up We hypothesize that 1 fewer and shorter fixations on ideographic ie personally relevant trauma words when reading the trauma narrative in the eye tracker will be associated with reductions in PTSD symptoms at follow-up 2 increased use of emotional words over the course of writing sessions will be associated with reductions in PTSD and depression symptoms at follow-up 3 pre- to posttreatment increases in trauma memory acceptance self-efficacy and 4 pre- to posttreatment reductions in trauma memory threat appraisals will be associated with greater symptom reduction at the follow-up assessment
Detailed Description:
None
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