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

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Disclosure
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Written Disclosure, Written Emotional Disclosure, Narrative Exposure, Narrative Writing, Motor Vehicle Accident

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Boston Healthcare System, National Center for PTSD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group 1 Treatment in Clinic

Group 2 Treatment via telephone

Group 3 Waitlist

Arm Description

Participants will complete the written disclosure treatment in a clinic setting.

Participants will complete the written disclosure treatment in their homes via telephone.

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.

Outcomes

Primary Outcome Measures

Clinician-Administered Posttraumatic Stress Disorder Scale

Secondary Outcome Measures

Beck Depression Inventory - Second Edition
Posttraumatic Cognitions Inventory
Anxious Driving Questionnaire
Client Satisfaction Questionnaire
Daily Experiences Questionnaire
Oswestry Disability Index
Quality of Life Inventory
Self-Assessment Manikin
Last Day of Writing Questionnaire
Follow-Up Writing Questionnaire
Alcohol Use Disorders Identification Test
Posttraumatic Stress Disorder Checklist - Civilian Version

Full Information

First Posted
March 16, 2009
Last Updated
February 26, 2018
Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00862498
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2008 (Actual)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Written Disclosure, Written Emotional Disclosure, Narrative Exposure, Narrative Writing, Motor Vehicle Accident

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 Treatment in Clinic
Arm Type
Experimental
Arm Description
Participants will complete the written disclosure treatment in a clinic setting.
Arm Title
Group 2 Treatment via telephone
Arm Type
Experimental
Arm Description
Participants will complete the written disclosure treatment in their homes via telephone.
Arm Title
Group 3 Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Written Disclosure
Other Intervention Name(s)
Written Emotional Disclosure, Narrative Writing, Narrative Exposure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Clinician-Administered Posttraumatic Stress Disorder Scale
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Secondary Outcome Measure Information:
Title
Beck Depression Inventory - Second Edition
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Title
Posttraumatic Cognitions Inventory
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Title
Anxious Driving Questionnaire
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Title
Client Satisfaction Questionnaire
Time Frame
Measured at the end of the last treatment session
Title
Daily Experiences Questionnaire
Time Frame
Measured every day during the 5-week treatment period
Title
Oswestry Disability Index
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Title
Quality of Life Inventory
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Title
Self-Assessment Manikin
Time Frame
Measured after each writing session
Title
Last Day of Writing Questionnaire
Time Frame
Measured after the last writing session
Title
Follow-Up Writing Questionnaire
Time Frame
Measured after the 3-month follow-up assessment
Title
Alcohol Use Disorders Identification Test
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups
Title
Posttraumatic Stress Disorder Checklist - Civilian Version
Time Frame
Measured at baseline, post-treatment, and at 3- and 6-month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise M. Sloan, PhD
Organizational Affiliation
VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System, National Center for PTSD
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
22863540
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.
Results Reference
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Examining Written Disclosure as a Treatment for Post-Traumatic Stress Disorder

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