Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder

Post Traumatic Stress Disorder Clinical Trial

Official title:

Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03229525
• Other study ID #: 2016-06-0063
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: September 2021

Study information

• Verified date: December 2019
• Source: University of Texas at Austin
• Contact: Michael Telch, PhD
• Phone: (512)-560-4100
• Email: telch[@]austin.utexas.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-traumatic Stress Disorder (PTSD) is a debilitating mental disorder that affects approximately 7% of the general population. This project's aim is to develop a greater understanding of the efficacy and underlying mechanisms of narrative exposure based treatments for PTSD. Adult participants (N=162) 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 (i.e. how long certain words are fixated on). (2) selected linguistic elements (i.e., 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 (i.e. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: September 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Males or females between the ages of 18 and 65

2. Meets Diagnostic and Statistical Manual 5 criteria for PTSD

3. Able to give consent

4. Access to a computer in a private place

5. Completes initial writing samples online

Exclusion Criteria:

1. Impaired vision

2. Bipolar Disorder

3. Psychosis

4. Suicidality

5. Current trauma related treatment

6. Psychotropic medication <2 months or not stable (dosage variable) in past 2 months

7. Reading grade level > 6th grade level

8. Obsessive Compulsive Disorder

9. Traumatic Brain Injury

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Trauma Related Expressive Writing
Participants will write about the traumatic event over the course of six sessions.
• Neutral Expressive Writing
Participants will write about a neutral event over the course of six sessions.

Locations

Country	Name	City	State
United States	Laboratory for the Study of Anxiety Disorders	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in PTSD symptom severity	PTSD Symptom Checklist at each assessment	Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months)
Primary	Change in Depression symptoms	Becks Depression Inventory at each assessment	Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Primary	Change in Posttraumatic Growth	Post Traumatic Growth Inventory at each assessment	Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Primary	Change in Reading Task indices	Reading narratives in an eye tracker at each assessment	Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Primary	Change in Sentence Production Task indices	Describing images in an eye tracker at each assessment	Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)

External Links

•   Description Website for the Laboratory for the Study of Anxiety Disorders