Clinical trial NCT00861666: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stress Disorders, Traumatic
Anxiety Disorders
PTSD
Keywords: Forgiveness
Writing
PTSD
OEF
OIF
Veterans
Lead sponsor: South Central VA Mental Illness Research, Education & Clinical Center
Sponsor class: FED
First posted: 2009-03-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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.

Primary outcomes:
measure: TEI-SF (Treatment Evaluation Inventory-Short Form)
timeFrame: One-month follow-up
measure: CSQ-8 (Client Satisfaction Questionnaire)
timeFrame: One-month follow-up
Secondary outcomes:
measure: SCID-PTSD Module
timeFrame: Baseline and One-Month Follow-up
measure: DASS-21 (Depression Anxiety and Stress Scales)
timeFrame: Baseline, One-week Post, and One-month Follow-up
measure: PCL-C (PTSD Checklist- Civilian Version)
timeFrame: Baseline, One-week Post, and One-month Follow-up
measure: PTCI (Posttraumatic Cognitions Inventory)
timeFrame: Baseline, One-week Post, One-month Follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey Veterans Affairs Medical Center
state: Texas
Study officials:
affiliation: MIRECC Affiliate
name: Catherine R. Barber, PhD
role: PRINCIPAL_INVESTIGATOR
References: