Forgiveness-Based Writing to Prevent Post-Traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
1 other identifier
interventional
20
1 country
1
Brief Summary
The purpose of this study is to evaluate a forgiveness-based writing intervention in an open trial with 20 Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) veterans who have recently experienced combat-related trauma to:
- 1.Determine the feasibility of delivering the intervention.
- 2.Evaluate the acceptability of the intervention.
- 3.Collect preliminary outcome data on PTSD symptoms, depression, anxiety, anger, and forgiveness.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2008
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 12, 2009
CompletedFirst Posted
Study publicly available on registry
March 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedJune 3, 2009
June 1, 2009
9 months
March 12, 2009
June 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
TEI-SF (Treatment Evaluation Inventory-Short Form)
One-month follow-up
CSQ-8 (Client Satisfaction Questionnaire)
One-month follow-up
Secondary Outcomes (4)
SCID-PTSD Module
Baseline and One-Month Follow-up
DASS-21 (Depression Anxiety and Stress Scales)
Baseline, One-week Post, and One-month Follow-up
PCL-C (PTSD Checklist- Civilian Version)
Baseline, One-week Post, and One-month Follow-up
PTCI (Posttraumatic Cognitions Inventory)
Baseline, One-week Post, One-month Follow-up
Study Arms (1)
Forgiveness-based Writing
OTHERInterventions
Participants will be asked to complete self-report measures during the initial session, will be given writing instructions and will complete the first writing task on-site. The first writing task will focus on describing an offense in which someone hurt or angered the participant, and about which the participant is still hurt and angry. Eleven additional writing tasks will be completed at home, three per week for a month. Writing assignments will include topics such as describing thoughts and feelings about the offense, identifying possible motives or mitigating circumstances, identifying benefits of the offense itself, identifying times when one has offended others and how one felt afterwards, identifying benefits of letting go of the offense, and writing a letter to the offender. Participants will return each written assignment to the study staff. All participants will be tracked closely by the study coordinator and receive a reminder phone call on the day of each writing task.
Eligibility Criteria
You may qualify if:
- Men and women of all racial/ethnic backgrounds between the ages of 18 and 64, seen in the identified settings (veteran participants must be OEF/OIF).
- Presence of sub-threshold PTSD as defined by Blanchard et al. (1994), related to combat experienced in the past 2 years.
- Ability to read, write, and speak English.
- Ability to attend on-site baseline and follow-up appointments.
- Ability to be contacted by phone with study reminders.
You may not qualify if:
- Primary psychotic disorder unrelated to PTSD.
- Impaired cognitive functioning.
- Current suicidal or homicidal intent.
- Symptoms meeting full PTSD diagnostic criteria.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine R. Barber, PhD
MIRECC Affiliate
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
March 12, 2009
First Posted
March 13, 2009
Study Start
October 1, 2008
Primary Completion
July 1, 2009
Study Completion
July 1, 2009
Last Updated
June 3, 2009
Record last verified: 2009-06