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Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder

Primary Purpose

Post Traumatic Stress Disorder

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Trauma Related Expressive Writing
Neutral Expressive Writing
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laboratory for the Study of Anxiety DisordersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Trauma Related Expressive Writing

Neutral Expressive Writing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in PTSD symptom severity
PTSD Symptom Checklist at each assessment
Change in Depression symptoms
Becks Depression Inventory at each assessment
Change in Posttraumatic Growth
Post Traumatic Growth Inventory at each assessment
Change in Reading Task indices
Reading narratives in an eye tracker at each assessment
Change in Sentence Production Task indices
Describing images in an eye tracker at each assessment

Secondary Outcome Measures

Full Information

First Posted
July 19, 2017
Last Updated
December 11, 2019
Sponsor
University of Texas at Austin
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1. Study Identification

Unique Protocol Identification Number
NCT03229525
Brief Title
Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder
Official Title
Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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: 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. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
162 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Trauma Related Expressive Writing
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Neutral Expressive Writing
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Trauma Related Expressive Writing
Intervention Description
Participants will write about the traumatic event over the course of six sessions.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Expressive Writing
Intervention Description
Participants will write about a neutral event over the course of six sessions.
Primary Outcome Measure Information:
Title
Change in PTSD symptom severity
Description
PTSD Symptom Checklist at each assessment
Time Frame
Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months)
Title
Change in Depression symptoms
Description
Becks Depression Inventory at each assessment
Time Frame
Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Title
Change in Posttraumatic Growth
Description
Post Traumatic Growth Inventory at each assessment
Time Frame
Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Title
Change in Reading Task indices
Description
Reading narratives in an eye tracker at each assessment
Time Frame
Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Title
Change in Sentence Production Task indices
Description
Describing images in an eye tracker at each assessment
Time Frame
Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females between the ages of 18 and 65 Meets Diagnostic and Statistical Manual 5 criteria for PTSD Able to give consent Access to a computer in a private place Completes initial writing samples online Exclusion Criteria: Impaired vision Bipolar Disorder Psychosis Suicidality Current trauma related treatment Psychotropic medication <2 months or not stable (dosage variable) in past 2 months Reading grade level > 6th grade level Obsessive Compulsive Disorder Traumatic Brain Injury
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Telch, PhD
Phone
(512)-560-4100
Email
telch@austin.utexas.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mikael Rubin, MA
Phone
6466854681
Email
mikaelrubin@utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Telch, Phd
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mikael Rubin, MA
Organizational Affiliation
University of Texas at Austin
Official's Role
Study Director
Facility Information:
Facility Name
Laboratory for the Study of Anxiety Disorders
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Rubin, MA

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://utanxiety.com
Description
Description Website for the Laboratory for the Study of Anxiety Disorders

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Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder

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