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Forgiveness-Based Writing to Prevent Post-Traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans

Primary Purpose

Stress Disorders, Traumatic, Anxiety Disorders, PTSD

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forgiveness-Based Writing
Sponsored by
South Central VA Mental Illness Research, Education & Clinical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress Disorders, Traumatic focused on measuring Forgiveness, Writing, PTSD, OEF, OIF, Veterans

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Primary psychotic disorder unrelated to PTSD.
  • Impaired cognitive functioning.
  • Current suicidal or homicidal intent.
  • Symptoms meeting full PTSD diagnostic criteria.

Sites / Locations

  • Michael E. DeBakey Veterans Affairs Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Forgiveness-based Writing

Arm Description

Outcomes

Primary Outcome Measures

TEI-SF (Treatment Evaluation Inventory-Short Form)
CSQ-8 (Client Satisfaction Questionnaire)

Secondary Outcome Measures

SCID-PTSD Module
DASS-21 (Depression Anxiety and Stress Scales)
PCL-C (PTSD Checklist- Civilian Version)
PTCI (Posttraumatic Cognitions Inventory)

Full Information

First Posted
March 12, 2009
Last Updated
June 1, 2009
Sponsor
South Central VA Mental Illness Research, Education & Clinical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00861666
Brief Title
Forgiveness-Based Writing to Prevent Post-Traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
Official Title
Forgiveness-Based Writing to Prevent Posttraumatic Stress Disorder in OEF/OIF Veterans
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
South Central VA Mental Illness Research, Education & Clinical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Determine the feasibility of delivering the intervention. Evaluate the acceptability of the intervention. Collect preliminary outcome data on PTSD symptoms, depression, anxiety, anger, and forgiveness.
Detailed Description
PTSD is a complex physiological, cognitive, emotional, and behavioral reaction to trauma comprising symptoms such as heightened arousal, emotional numbing, avoidance of trauma-related cues, and re-experiencing aspects of the trauma. Estimates indicate that 16.6% of OEF/OIF veterans returning from deployment develop PTSD (Hoge et al., 2007), much higher than the overall prevalence rate of 6.8% among adults in the United States (Kessler et al., 2005). Although efficacious treatments for PTSD are available, considerably less is known about preventing its progression from sub-threshold symptoms to full PTSD (Feldner, Manson, & Friedman, 2007). This is disconcerting because studies show that sub-threshold PTSD is a potential risk factor for the development of PTSD (e.g., Buckley, Blanchard, & Hickling, 1996; Carty, O'Donnell, & Creamer, 2006). Thus, there is a need for the development and evaluation of brief preventive interventions that can be easily and effectively implemented with individuals who have sub-threshold PTSD, defined as meeting either DSM-IV PTSD criteria B and C or B and D, but failing to meet all three, and experiencing at least one month of significant impairment (Blanchard et al., 1994). Although treatments for PTSD such as Cognitive Processing Therapy (CPT) and Prolonged Exposure (PE) have been generally successful with individuals with full-blown PTSD (Foa et al., 1991; Monson et al., 2006; Schnurr et al., 2007), these treatments have not been systematically evaluated within a context of prevention and applied to individuals with sub-threshold symptoms. Furthermore, despite the effectiveness of available treatments for trauma symptoms, several identified barriers to treatment exist for veteran populations, particularly those who live in rural settings. These barriers to care highlight the need for brief, cost-effective, and self-managed interventions aimed at reducing attrition, providing symptom relief, and preventing PTSD in rural and underserved populations. One potentially valuable intervention is expressive writing (i.e., writing thoughts and feelings about a significant life event). Expressive writing is associated with large improvements in psychiatric and physical symptoms and can be modified to suit the needs of specified groups (e.g., Frisina, Borod, & Lepore, 2004; Pennebaker, 2004; Smyth, 1998). Forgiving others can decrease physiological arousal (Lawler et al., 2003; Witvliet, Ludwig, & VanderLaan, 2001), depression, anxiety, and post-traumatic stress (Reed & Enright, 2006), as well as anger and substance use (Lin et al., 2004), while self-forgiveness is associated with improved quality of life and decreased mood disturbance (Friedman et al., 2007; Romero et al., 2006). Thus, a forgiveness-based writing intervention may be particularly powerful for addressing responses to trauma. Although previous studies have examined forgiveness-based writing interventions (McCullough, Root, & Cohen, 2006; Romero, 2008), none has examined the benefits of forgiveness-based writing for patients with sub-threshold PTSD symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Traumatic, Anxiety Disorders, PTSD
Keywords
Forgiveness, Writing, PTSD, OEF, OIF, Veterans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Forgiveness-based Writing
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Forgiveness-Based Writing
Intervention Description
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.
Primary Outcome Measure Information:
Title
TEI-SF (Treatment Evaluation Inventory-Short Form)
Time Frame
One-month follow-up
Title
CSQ-8 (Client Satisfaction Questionnaire)
Time Frame
One-month follow-up
Secondary Outcome Measure Information:
Title
SCID-PTSD Module
Time Frame
Baseline and One-Month Follow-up
Title
DASS-21 (Depression Anxiety and Stress Scales)
Time Frame
Baseline, One-week Post, and One-month Follow-up
Title
PCL-C (PTSD Checklist- Civilian Version)
Time Frame
Baseline, One-week Post, and One-month Follow-up
Title
PTCI (Posttraumatic Cognitions Inventory)
Time Frame
Baseline, One-week Post, One-month Follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Primary psychotic disorder unrelated to PTSD. Impaired cognitive functioning. Current suicidal or homicidal intent. Symptoms meeting full PTSD diagnostic criteria.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine R. Barber, PhD
Phone
713-873-5134
Email
romeroc@bcm.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Shepherd, B.S.
Phone
713-794-8821
Email
shepherd.alexandra@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine R. Barber, PhD
Organizational Affiliation
MIRECC Affiliate
Official's Role
Principal Investigator
Facility Information:
Facility Name
Michael E. DeBakey Veterans Affairs Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine R. Barber, Ph.D.
Phone
713-873-5143
Email
romeroc@bcm.tmc.edu
First Name & Middle Initial & Last Name & Degree
Alexandra Shepherd, B.S.
Phone
713-794-8821
Email
shepherd.alexandra@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Forgiveness-Based Writing to Prevent Post-Traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans

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