- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773811
Effects of Narrative Writing Duration and Post-writing Processing Instructions on PTSD
May 14, 2014 updated by: University of Mississippi, Oxford
The current study proposes to directly measure how processing after participating in written disclosure about a traumatic life event affects physical and psychological outcomes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous research has established the potential for narrative writing about traumatic events to result in positive benefits for physical and psychological health.
Research has also provided evidence that written disclosure may reduce post-traumatic stress disorder (PTSD) symptoms.
Several mechanisms of action have been proposed to explain why written disclosure produces positive benefits, but all have focused on processes occurring during the writing session.
It has been suggested, however, that additional processing may occur after the writing exercises are over, yet no research has studied the influence of this processing on outcomes.
The current study proposes to directly measure how processing after participating in written disclosure affects physical and psychological outcomes.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mississippi
-
University, Mississippi, United States, 38677
- The University of Mississippi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Experienced a traumatic life event (DSM-IV-TR Criterion A)
- Currently experiencing clinically significant levels of PTSD symptoms
Exclusion Criteria:
- Currently receiving psychotherapy
- On medication that is not stable (i.e. medication has been changed within the past 6 weeks)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Individuals will write objectively about the events of their day.
|
|
Experimental: Narrative Writing: Trauma-Assigned
Trauma-assigned: Individuals will write about their most traumatic life experience and be instructed to continue to think about their writing topic in the weeks following writing.
|
Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each.
Those in the assigned group will be given instructions and weekly reminders to continue to think about their most traumatic event.
|
Active Comparator: Narrative Writing: Trauma-Spontaneous
Individuals will write about their most traumatic life experience but will not be given further instructions for processing.
Any additional processing about their writing topic in the weeks following writing will be considered spontaneous.
|
Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each.
Those in the spontaneous group will be given no further instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Level of PTSD symptoms as measured by the Clinician Administered PTSD Scale
Time Frame: 1 month after final writing session
|
1 month after final writing session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical health
Time Frame: 1 month after final writing session
|
Physical health as measured by the Pennebaker Inventory of Limibic Languidness (PILL)
|
1 month after final writing session
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tom Lombardo, PhD, University of Mississippi, Oxford
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
January 18, 2013
First Submitted That Met QC Criteria
January 18, 2013
First Posted (Estimate)
January 23, 2013
Study Record Updates
Last Update Posted (Estimate)
May 15, 2014
Last Update Submitted That Met QC Criteria
May 14, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMO-0004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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