Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00862498
Recruitment Status : Completed
First Posted : March 17, 2009
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Denise M. Sloan, Boston University

Tracking Information
First Submitted Date  ICMJE March 16, 2009
First Posted Date  ICMJE March 17, 2009
Last Update Posted Date February 28, 2018
Actual Study Start Date  ICMJE August 2008
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post-Traumatic Stress Disorder
Intervention  ICMJE 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 19, 2012)
48
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2009)
90
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862498
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: Undecided
Responsible Party Denise M. Sloan, Boston University
Study Sponsor  ICMJE Boston University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP