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

Sponsor

Boston University (Other)

Overall Status

Completed

CT.gov ID

NCT00862498

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder	Other: Written Disclosure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Examining Written Disclosure as an Intervention for Posttraumatic Stress Disorder

Actual Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 Treatment in Clinic Participants will complete the written disclosure treatment in a clinic setting.	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: Group 2 Treatment via telephone Participants will complete the written disclosure treatment in their homes via telephone.	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
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.

Arm

Intervention/Treatment

Experimental: Group 1 Treatment in Clinic

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

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: Group 2 Treatment via telephone

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

Other: Written Disclosure

Other Names:

Written Emotional Disclosure

Narrative Writing

Narrative Exposure

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.

Outcome Measures

Primary Outcome Measures

Clinician-Administered Posttraumatic Stress Disorder Scale [Measured at baseline, post-treatment, and at 3- and 6-month follow-ups]

Secondary Outcome Measures

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]
Oswestry Disability Index [Measured at baseline, post-treatment, and at 3- and 6-month follow-ups]
Quality of Life Inventory [Measured at baseline, post-treatment, and at 3- and 6-month follow-ups]
Self-Assessment Manikin [Measured after each writing session]
Last Day of Writing Questionnaire [Measured after the last writing session]
Follow-Up Writing Questionnaire [Measured after the 3-month follow-up assessment]
Alcohol Use Disorders Identification Test [Measured at baseline, post-treatment, and at 3- and 6-month follow-ups]
Posttraumatic Stress Disorder Checklist - Civilian Version [Measured at baseline, post-treatment, and at 3- and 6-month follow-ups]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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