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

Anxiety Disorders Clinical Trial

Official title:

Forgiveness-Based Writing to Prevent Posttraumatic Stress Disorder in OEF/OIF Veterans

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00861666
• Other study ID #: H-23892
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2009
• Last updated: June 1, 2009
• Start date: October 2008
• Est. completion date: July 2009

Study information

• Verified date: June 2009
• Source: South Central VA Mental Illness Research, Education & Clinical Center
• Contact: Catherine R. Barber, PhD
• Phone: 713-873-5134
• Email: romeroc[@]bcm.tmc.edu
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
South Central VA Mental Illness Research, Education & Clinical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEI-SF (Treatment Evaluation Inventory-Short Form)		One-month follow-up	No
Primary	CSQ-8 (Client Satisfaction Questionnaire)		One-month follow-up	No
Secondary	SCID-PTSD Module		Baseline and One-Month Follow-up	No
Secondary	DASS-21 (Depression Anxiety and Stress Scales)		Baseline, One-week Post, and One-month Follow-up	No
Secondary	PCL-C (PTSD Checklist- Civilian Version)		Baseline, One-week Post, and One-month Follow-up	No
Secondary	PTCI (Posttraumatic Cognitions Inventory)		Baseline, One-week Post, One-month Follow-up	No