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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by South Central VA Mental Illness Research, Education & Clinical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
South Central VA Mental Illness Research, Education & Clinical Center
ClinicalTrials.gov Identifier:
NCT00861666
First received: March 12, 2009
Last updated: June 1, 2009
Last verified: June 2009
  Purpose

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 Intervention
Stress Disorders, Traumatic
Anxiety Disorders
PTSD
Behavioral: Forgiveness-Based Writing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Forgiveness-Based Writing to Prevent Posttraumatic Stress Disorder in OEF/OIF Veterans

Resource links provided by NLM:


Further study details as provided by South Central VA Mental Illness Research, Education & Clinical Center:

Primary Outcome Measures:
  • TEI-SF (Treatment Evaluation Inventory-Short Form) [ Time Frame: One-month follow-up ] [ Designated as safety issue: No ]
  • CSQ-8 (Client Satisfaction Questionnaire) [ Time Frame: One-month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SCID-PTSD Module [ Time Frame: Baseline and One-Month Follow-up ] [ Designated as safety issue: No ]
  • DASS-21 (Depression Anxiety and Stress Scales) [ Time Frame: Baseline, One-week Post, and One-month Follow-up ] [ Designated as safety issue: No ]
  • PCL-C (PTSD Checklist- Civilian Version) [ Time Frame: Baseline, One-week Post, and One-month Follow-up ] [ Designated as safety issue: No ]
  • PTCI (Posttraumatic Cognitions Inventory) [ Time Frame: Baseline, One-week Post, One-month Follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861666

Contacts
Contact: Catherine R. Barber, PhD 713-873-5134 romeroc@bcm.tmc.edu
Contact: Alexandra Shepherd, B.S. 713-794-8821 shepherd.alexandra@gmail.com

Locations
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    romeroc@bcm.tmc.edu   
Contact: Alexandra Shepherd, B.S.    713-794-8821    shepherd.alexandra@gmail.com   
Sponsors and Collaborators
South Central VA Mental Illness Research, Education & Clinical Center
Investigators
Principal Investigator: Catherine R. Barber, PhD MIRECC Affiliate
  More Information

No publications provided

Responsible Party: Catherine Romero Barber, MIRECC affiliate
ClinicalTrials.gov Identifier: NCT00861666     History of Changes
Other Study ID Numbers: H-23892
Study First Received: March 12, 2009
Last Updated: June 1, 2009
Health Authority: United States: Federal Government

Keywords provided by South Central VA Mental Illness Research, Education & Clinical Center:
Forgiveness
Writing
PTSD
OEF
OIF
Veterans

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Anxiety Disorders
Stress Disorders, Post-Traumatic
Pathologic Processes
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014