Clinical trial NCT03229525: Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder
Official title: Narrative Exposure Based Intervention For Post-Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-07-25
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in PTSD symptom severity
timeFrame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month, 3 months, 6 months)
measure: Change in Depression symptoms
timeFrame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
measure: Change in Posttraumatic Growth
timeFrame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
measure: Change in Reading Task indices
timeFrame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
measure: Change in Sentence Production Task indices
timeFrame: Pre-treatment (baseline), Post-treatment (2-weeks), Follow-up (1 month)
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Laboratory for the Study of Anxiety Disorders
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Michael Telch, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas at Austin
name: Mikael Rubin, MA
role: STUDY_DIRECTOR
References: