Stress Disorders, TraumaticNCT00861666
Forgiveness-Based Writing to Prevent Post-Traumatic Stress Disorder (PTSD) in Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans
A study testing Forgiveness-Based Writing in people with Stress Disorders, Traumatic and Anxiety Disorders, run by South Central VA Mental Illness Research, Education & Clinical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Stress Disorders, Traumatic, Anxiety Disorders, PTSD
- What is being tested?
- Forgiveness-Based Writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Jul 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Primary psychotic disorder unrelated to PTSD.
- Impaired cognitive functioning.
- Current suicidal or homicidal intent.
- Symptoms meeting full PTSD diagnostic criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, 77030
Catherine R. Barber, Ph.D., 713-873-5143, romeroc@bcm.tmc.edu
Alexandra Shepherd, B.S., 713-794-8821, shepherd.alexandra@gmail.com
About this study
Official title: Forgiveness-Based Writing to Prevent Posttraumatic Stress Disorder in OEF/OIF Veterans
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.
Read the 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.
- Conditions
- Stress Disorders, Traumatic, Anxiety Disorders, PTSD
- Being tested
- Forgiveness-Based Writing
- Keywords
- Forgiveness, Writing, PTSD, OEF, OIF, Veterans
- Medical subject headings
- Stress Disorders, Traumatic, Anxiety Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forgiveness-Based WritingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Forgiveness-based Writing | Other | Not described Receives: Behavioral: Forgiveness-Based Writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEI-SF (Treatment Evaluation Inventory-Short Form)
Measured: One-month follow-up
CSQ-8 (Client Satisfaction Questionnaire)
Measured: One-month follow-up
Secondary outcomes (4)
SCID-PTSD Module
Measured: Baseline and One-Month Follow-up
DASS-21 (Depression Anxiety and Stress Scales)
Measured: Baseline, One-week Post, and One-month Follow-up
PCL-C (PTSD Checklist- Civilian Version)
Measured: Baseline, One-week Post, and One-month Follow-up
PTCI (Posttraumatic Cognitions Inventory)
Measured: Baseline, One-week Post, One-month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Disorders, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Central VA Mental Illness Research, Education & Clinical Center
- Sponsor type
- US federal agency
- Investigators
- Catherine R. Barber, PhD, Principal investigator, MIRECC Affiliate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00861666
- Sponsor's protocol ID
- H-23892
- Status last verified
- Jun 2009
- First submitted
- 12 Mar 2009
- Last updated
- 3 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forgiveness-Based Writing to Prevent Posttraumatic Stress Disorder in OEF/OIF Veterans
- ClinicalTrials.gov ID
- NCT00861666
- Acronym / sponsor ID
- H-23892
- Conditions
- Stress Disorders, Traumatic, Anxiety Disorders, PTSD
- Keywords
- Forgiveness, Writing, PTSD, OEF, OIF, Veterans
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Central VA Mental Illness Research, Education & Clinical CenterUS federal agency
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 13 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Forgiveness-based Writing | Other | Behavioral: Forgiveness-Based Writing |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Primary psychotic disorder unrelated to PTSD.
- Impaired cognitive functioning.
- Current suicidal or homicidal intent.
- Symptoms meeting full PTSD diagnostic criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forgiveness-Based WritingParticipants 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. | Behavioural | Forgiveness-based Writing |
Primary outcome
TEI-SF (Treatment Evaluation Inventory-Short Form)
Time frame: One-month follow-up
CSQ-8 (Client Satisfaction Questionnaire)
Time frame: One-month follow-up
4 secondary outcomes
SCID-PTSD Module
Time frame: Baseline and One-Month Follow-up
DASS-21 (Depression Anxiety and Stress Scales)
Time frame: Baseline, One-week Post, and One-month Follow-up
PCL-C (PTSD Checklist- Civilian Version)
Time frame: Baseline, One-week Post, and One-month Follow-up
PTCI (Posttraumatic Cognitions Inventory)
Time frame: Baseline, One-week Post, One-month Follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine R. Barber, PhD principal investigator
MIRECC Affiliate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forgiveness-Based Writing in people with Stress Disorders, Traumatic and Anxiety Disorders, run by South Central VA Mental Illness Research, Education & Clinical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine R. Barber, PhD (713-873-5134, romeroc@bcm.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TEI-SF (Treatment Evaluation Inventory-Short Form) (time frame: One-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2009.