Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Trauma Related Expressive Writing; Behavioral: Neutral Expressive Writing

• Study Type: Interventional
• Enrollment (Anticipated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Telch, PhD; Phone Number: (512)-560-4100; Email: telch@austin.utexas.edu
• Study Contact Backup: Name: Mikael Rubin, MA; Phone Number: 6466854681; Email: mikaelrubin@utexas.edu

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • Recruiting
      • Laboratory for the Study of Anxiety Disorders
      • Contact: Mikael Rubin, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trauma Related Expressive Writing; Participants randomized to this condition will complete six sessions during which they will write about their trauma for 20 minutes. The participant will receive instructions to write about the traumatic event that they feel affects them the most. For each session they will be instructed to write about the same event. For the first session, participants will complete psychoeducation and treatment rationale modules. The instructions for writing about the traumatic event will emphasize the importance of exploring their deepest emotions and thoughts at the time of the event, as well as providing detailed information about the event itself. For the remaining five writing sessions participants will be instructed to write about the same event and to focus on providing a detailed description of the part of the event that was most distressing to them, as well as how the event had affected their lives. A researcher will review the writing independently to ensure treatment compliance.	Behavioral: Trauma Related Expressive Writing; Participants will write about the traumatic event over the course of six sessions.
Sham Comparator: Neutral Expressive Writing; Participants randomized to this condition will complete six sessions during which they will write about their day, without describing emotions or opinions. Previous research has shown a significant reduction of symptoms with this type of control writing condition in participants with PTSD (Sloan et al., 2011). A researcher will review the writing to ensure compliance.	Behavioral: Neutral Expressive Writing; Participants will write about a neutral event over the course of six sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change in Depression symptoms	Becks Depression Inventory at each assessment	Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Change in Posttraumatic Growth	Post Traumatic Growth Inventory at each assessment	Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
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)
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)

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Investigators: Principal Investigator: Michael Telch, Phd, University of Texas at Austin; Study Director: Mikael Rubin, MA, University of Texas at Austin

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): February 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 21, 2017
• First Posted (Actual): July 25, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 2016-06-0063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No