NCT00862498

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

3 years

First QC Date

March 16, 2009

Last Update Submit

February 26, 2018

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSDWritten DisclosureWritten Emotional DisclosureNarrative ExposureNarrative WritingMotor Vehicle Accident

Outcome Measures

Primary Outcomes (1)

  • Clinician-Administered Posttraumatic Stress Disorder Scale

    Measured at baseline, post-treatment, and at 3- and 6-month follow-ups

Secondary Outcomes (12)

  • Beck Depression Inventory - Second Edition

    Measured at baseline, post-treatment, and at 3- and 6-month follow-ups

  • Posttraumatic Cognitions Inventory

    Measured at baseline, post-treatment, and at 3- and 6-month follow-ups

  • Anxious Driving Questionnaire

    Measured at baseline, post-treatment, and at 3- and 6-month follow-ups

  • Client Satisfaction Questionnaire

    Measured at the end of the last treatment session

  • Daily Experiences Questionnaire

    Measured every day during the 5-week treatment period

  • +7 more secondary outcomes

Study Arms (3)

Group 1 Treatment in Clinic

EXPERIMENTAL

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

Other: Written Disclosure

Group 2 Treatment via telephone

EXPERIMENTAL

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

Other: Written Disclosure

Group 3 Waitlist

NO INTERVENTION

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.

Interventions

Written DisclosureOTHER

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.

Also known as: Written Emotional Disclosure, Narrative Writing, Narrative Exposure
Group 1 Treatment in ClinicGroup 2 Treatment via telephone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System, National Center for PTSD

Boston, Massachusetts, 02130, United States

Location

Related Publications (1)

  • 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.

    PMID: 22863540RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Denise M. Sloan, PhD

    VA Boston Healthcare System, National Center for PTSD; Boston University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

March 16, 2009

First Posted

March 17, 2009

Study Start

August 1, 2008

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

US(1)