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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Denise Sloan, Boston University
ClinicalTrials.gov Identifier:
NCT00862498
First received: March 16, 2009
Last updated: July 19, 2012
Last verified: July 2012

March 16, 2009
July 19, 2012
August 2008
August 2011   (final data collection date for primary outcome measure)
Clinician-Administered Posttraumatic Stress Disorder Scale [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
Clinician-Administered Posttraumatic Stress Disorder Scale [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00862498 on ClinicalTrials.gov Archive Site
  • Beck Depression Inventory - Second Edition [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Posttraumatic Cognitions Inventory [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Anxious Driving Questionnaire [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire [ Time Frame: Measured at the end of the last treatment session ] [ Designated as safety issue: No ]
  • Daily Experiences Questionnaire [ Time Frame: Measured every day during the 5-week treatment period ] [ Designated as safety issue: No ]
  • Oswestry Disability Index [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Self-Assessment Manikin [ Time Frame: Measured after each writing session ] [ Designated as safety issue: No ]
  • Last Day of Writing Questionnaire [ Time Frame: Measured after the last writing session ] [ Designated as safety issue: No ]
  • Follow-Up Writing Questionnaire [ Time Frame: Measured after the 3-month follow-up assessment ] [ Designated as safety issue: No ]
  • Alcohol Use Disorders Identification Test [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Posttraumatic Stress Disorder Checklist - Civilian Version [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow-ups ] [ Designated as safety issue: No ]
  • Beck Depression Inventory - Second Edition [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
  • Posttraumatic Cognitions Inventory [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
  • Anxious Driving Questionnaire [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire [ Time Frame: Measured at the end of the last treatment session ] [ Designated as safety issue: No ]
  • Daily Experiences Questionnaire [ Time Frame: Measured every day during the 5-week treatment period ] [ Designated as safety issue: No ]
  • Oswestry Disability Index [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
  • Self-Assessment Manikin [ Time Frame: Measured after each writing session ] [ Designated as safety issue: No ]
  • Last Day of Writing Questionnaire [ Time Frame: Measured after the last writing session ] [ Designated as safety issue: No ]
  • Follow-Up Writing Questionnaire [ Time Frame: Measured after the 3-month follow-up assessment ] [ Designated as safety issue: No ]
  • Alcohol Use Disorders Identification Test [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
  • Posttraumatic Stress Disorder Checklist - Civilian Version [ Time Frame: Measured at baseline, post-treatment, and at 3- and 6-month follow ups ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder
Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
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
  • Experimental: 1
    Participants will complete the written disclosure treatment in a clinic setting.
    Intervention: Other: Written Disclosure
  • Experimental: 2
    Participants will complete the written disclosure treatment in their homes via telephone.
    Intervention: Other: Written Disclosure
  • No Intervention: 3
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00862498
R34 MH077658, R34MH077658, DATR AD-TS, 1R34MH077658-01A2
No
Denise Sloan, Boston University
Boston University
National Institute of Mental Health (NIMH)
Principal Investigator: Denise M. Sloan, PhD VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
Boston University
July 2012

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