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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00861666
Recruitment Status : Unknown
Verified June 2009 by South Central VA Mental Illness Research, Education & Clinical Center.
Recruitment status was:  Recruiting
First Posted : March 13, 2009
Last Update Posted : June 3, 2009
Information provided by:
South Central VA Mental Illness Research, Education & Clinical Center

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.

Condition or disease Intervention/treatment
Stress Disorders, Traumatic Anxiety Disorders PTSD Behavioral: Forgiveness-Based Writing

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Forgiveness-Based Writing to Prevent Posttraumatic Stress Disorder in OEF/OIF Veterans
Study Start Date : October 2008
Estimated Primary Completion Date : July 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Forgiveness-based Writing Behavioral: Forgiveness-Based Writing

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 Measures :
  1. TEI-SF (Treatment Evaluation Inventory-Short Form) [ Time Frame: One-month follow-up ]
  2. CSQ-8 (Client Satisfaction Questionnaire) [ Time Frame: One-month follow-up ]

Secondary Outcome Measures :
  1. SCID-PTSD Module [ Time Frame: Baseline and One-Month Follow-up ]
  2. DASS-21 (Depression Anxiety and Stress Scales) [ Time Frame: Baseline, One-week Post, and One-month Follow-up ]
  3. PCL-C (PTSD Checklist- Civilian Version) [ Time Frame: Baseline, One-week Post, and One-month Follow-up ]
  4. PTCI (Posttraumatic Cognitions Inventory) [ Time Frame: Baseline, One-week Post, One-month Follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00861666

Contact: Catherine R. Barber, PhD 713-873-5134
Contact: Alexandra Shepherd, B.S. 713-794-8821

United States, Texas
Michael E. DeBakey Veterans Affairs Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Catherine R. Barber, Ph.D.    713-873-5143   
Contact: Alexandra Shepherd, B.S.    713-794-8821   
Sponsors and Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
Principal Investigator: Catherine R. Barber, PhD MIRECC Affiliate

Responsible Party: Catherine Romero Barber, MIRECC affiliate Identifier: NCT00861666     History of Changes
Other Study ID Numbers: H-23892
First Posted: March 13, 2009    Key Record Dates
Last Update Posted: June 3, 2009
Last Verified: June 2009

Keywords provided by South Central VA Mental Illness Research, Education & Clinical Center:

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Anxiety Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders