Clinical trial NCT00862498: Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
Official title: Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Keywords: PTSD
Written Disclosure
Written Emotional Disclosure
Narrative Exposure
Narrative Writing
Motor Vehicle Accident
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-03-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness of writing about a traumatic incident to treat post-traumatic stress disorder in people who have been in car accidents.

Detailed description: Post-traumatic stress disorder (PTSD) is a chronic and debilitating disorder caused by experiencing a stressful or traumatic event. Although there is evidence that treatments for PTSD are effective, many people do not seek treatment or seek treatment only after their PTSD has become severe. This study will test a low-cost, brief, and easily implemented treatment that may encourage people to seek treatment for PTSD. The treatment, called written disclosure (WD), involves writing about the traumatic event that caused a person's PTSD. In this study, people who have PTSD as the result of a motor vehicle accident will test two versions of WD, one administered in a clinic and the other administered over the phone.

Participation in this study will last 5 weeks, with follow-up assessments continuing until 6 months after treatment. After screening, participants will be assigned to one of three conditions: WD treatment delivered in the clinic, WD treatment delivered via phone, and waitlist. The WD treatment involves five weekly writing sessions. During the first session, trauma reactions and the rationale for WD will be explained to all participants, and then participants will write for 30 minutes about their motor vehicle accident. The next four sessions will involve only writing for 30 minutes. For those receiving treatment in the clinic, a therapist will communicate directions and explanations to participants, and participants will have their heart rate activity recorded continuously for 5 minutes prior to writing and during the 30 minutes of writing. For those receiving treatment over the phone, explanations of the study will be provided in writing, and a study staff member will call participants before and after each writing session to ensure that participants understand the directions and are not experiencing any unexpected negative reactions after writing. Participants in the waitlist condition will not receive treatment for the first 4 months. After that period, they will be offered the WD treatment.

Assessments of all participants will occur at baseline, after treatment, and 3 months after treatment. Participants assigned to receive WD treatment, either in a clinic or via phone, will also be assessed 6 months after treatment. Assessments administered at these points will involve semi-structured clinical interviews, self-report questionnaires, and measures of mood-related symptoms. Participants receiving treatment will also complete self-report measurements of emotional response after each writing session and the Daily Experiences Questionnaire every day during the 5 weeks of treatment. Participants on the waitlist will also undergo assessments of suicidal thoughts and PTSD symptoms every 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of post-traumatic stress disorder
* Involved in motor vehicle accident that occurred at least 3 months ago

Exclusion Criteria:

* Current diagnosis of mania, hypomania, bipolar depression, psychotic disorder, substance abuse disorder, or severe depression
* History of psychosis
* Active suicidality or history of two or more suicide gestures or attempts in the past year
* Significant cognitive impairment
* Current participation in a psychosocial treatment, such as individual or group therapy led by a clinician

Primary outcomes:
measure: Clinician-Administered Posttraumatic Stress Disorder Scale
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Secondary outcomes:
measure: Beck Depression Inventory - Second Edition
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
measure: Posttraumatic Cognitions Inventory
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
measure: Anxious Driving Questionnaire
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
measure: Client Satisfaction Questionnaire
timeFrame: Measured at the end of the last treatment session
measure: Daily Experiences Questionnaire
timeFrame: Measured every day during the 5-week treatment period
measure: Oswestry Disability Index
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
measure: Quality of Life Inventory
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
measure: Self-Assessment Manikin
timeFrame: Measured after each writing session
measure: Last Day of Writing Questionnaire
timeFrame: Measured after the last writing session
measure: Follow-Up Writing Questionnaire
timeFrame: Measured after the 3-month follow-up assessment
measure: Alcohol Use Disorders Identification Test
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
measure: Posttraumatic Stress Disorder Checklist - Civilian Version
timeFrame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System, National Center for PTSD
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
name: Denise M. Sloan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sloan DM, Marx BP, Bovin MJ, Feinstein BA, Gallagher MW. Written exposure as an intervention for PTSD: a randomized clinical trial with motor vehicle accident survivors. Behav Res Ther. 2012 Oct;50(10):627-35. doi: 10.1016/j.brat.2012.07.001. Epub 2012 Jul 20.