Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder

• ClinicalTrials.gov Identifier: NCT00862498
• Recruitment Status: Completed
• First Posted: March 17, 2009
• Last Update Posted: February 28, 2018
• Sponsor: Boston University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Denise M. Sloan, Boston University

Tracking Information

• First Submitted Date: March 16, 2009
• First Posted Date: March 17, 2009
• Last Update Posted Date: February 28, 2018
• Actual Study Start Date: August 2008
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 16, 2009): Clinician-Administered Posttraumatic Stress Disorder Scale [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 16, 2009)

• Beck Depression Inventory - Second Edition [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]
• Posttraumatic Cognitions Inventory [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]
• Anxious Driving Questionnaire [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]
• Client Satisfaction Questionnaire [ Time Frame: Measured at the end of the last treatment session ]
• Daily Experiences Questionnaire [ Time Frame: Measured every day during the 5-week treatment period ]
• Oswestry Disability Index [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]
• Quality of Life Inventory [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]
• Self-Assessment Manikin [ Time Frame: Measured after each writing session ]
• Last Day of Writing Questionnaire [ Time Frame: Measured after the last writing session ]
• Follow-Up Writing Questionnaire [ Time Frame: Measured after the 3-month follow-up assessment ]
• Alcohol Use Disorders Identification Test [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]
• Posttraumatic Stress Disorder Checklist - Civilian Version [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
• Official Title: Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Post-Traumatic Stress Disorder

Intervention

Other: Written Disclosure

Five sessions, each spaced 1 week apart, during which participants are asked to write about their motor vehicle accident for 30 minutes. The first session of the intervention also involves a description of common reactions to a motor vehicle accident and the rationale for this treatment.

Other Names:

• Written Emotional Disclosure
• Narrative Writing
• Narrative Exposure

Study Arms

• Experimental: Group 1 Treatment in Clinic
  Participants will complete the written disclosure treatment in a clinic setting.
  Intervention: Other: Written Disclosure
• Experimental: Group 2 Treatment via telephone
  Participants will complete the written disclosure treatment in their homes via telephone.
  Intervention: Other: Written Disclosure
• No Intervention: Group 3 Waitlist
  Individuals will be placed on a waitlist for a period of 4 months, during which they will receive a phone call every other week to assess their suicidal ideation and post-traumatic stress disorder symptom severity.

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 19, 2012): 48
• Original Estimated Enrollment (submitted: March 16, 2009): 90
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00862498
• Other Study ID Numbers: H-27236; R34MH077658 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Denise M. Sloan, Boston University
• Study Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Denise M. Sloan, PhD; VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine

• PRS Account: Boston University
• Verification Date: February 2018