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Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT03229525
Recruitment Status : Recruiting
First Posted : July 25, 2017
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

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:

  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 mediational effects of pre- to posttreatment changes in (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.

Condition or disease Intervention/treatment Phase
Post Traumatic Stress Disorder Behavioral: Trauma Related Expressive Writing Behavioral: Trauma Related Expressive Speaking Behavioral: Neutral Expressive Writing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


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.

Active Comparator: Trauma Related Expressive Speaking
Participants randomized to this condition will complete six sessions during which they will speak about their trauma for 20 minutes. The participant will receive instructions to speak about the traumatic event that they feel affects them the most. For each session they will be instructed to speak about the same event. For the first session, participants will complete psychoeducation and treatment rationale modules. The instructions for speaking 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 sessions participants will be instructed to speak 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 recording independently to ensure treatment compliance.
Behavioral: Trauma Related Expressive Speaking
Participants will speak 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.




Primary Outcome Measures :
  1. Change in PTSD symptom severity [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months) ]
    PTSD Symptom Checklist at each assessment

  2. Change in Depression symptoms [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]
    Becks Depression Inventory at each assessment

  3. Change in Posttraumatic Growth [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]
    Post Traumatic Growth Inventory at each assessment

  4. Change in Reading Task indices [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]
    Reading narratives in an eye tracker at each assessment

  5. Change in Sentence Production Task indices [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]
    Describing images in an eye tracker at each assessment



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03229525


Contacts
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Contact: Michael Telch, PhD (512)-560-4100 telch@austin.utexas.edu
Contact: Mikael Rubin, MA 6466854681 mikaelrubin@utexas.edu

Locations
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United States, Texas
Laboratory for the Study of Anxiety Disorders Recruiting
Austin, Texas, United States, 78712
Contact: Mikael Rubin, MA         
Sponsors and Collaborators
University of Texas at Austin
Investigators
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Principal Investigator: Michael Telch, Phd University of Texas at Austin
Study Director: Mikael Rubin, MA University of Texas at Austin

Additional Information:
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Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03229525     History of Changes
Other Study ID Numbers: 2016-06-0063
First Posted: July 25, 2017    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders