Recruiting

Narrative Exposure

Sponsor:

University of Texas at Austin

Code:

NCT03229525

Conditions

Post Traumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Trauma Related Expressive Writing

Neutral Expressive Writing

Study Details

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 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.

Conditions

Post Traumatic Stress Disorder

Study ID

NCT03229525

Start date

Sep 1, 2017

Status verified date

Dec, 2019

Completion date

Sep, 2021

Anticipated

Primary completion date

Feb, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in PTSD symptom severity [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months) ]
  • Change in Depression symptoms [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]
  • Change in Posttraumatic Growth [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]
  • Change in Reading Task indices [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]
  • Change in Sentence Production Task indices [ Time Frame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month) ]

Central Contacts and Locations

Central contacts

Locations

Laboratory for the Study of Anxiety Disorders

Recruiting

Austin, Texas, United States, 78712

More Information

Sponsor

University of Texas at Austin

Last update posted

Dec 13, 2019

Last verified

Dec, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2019-12-13.