NCT00861666

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. 1.Determine the feasibility of delivering the intervention.
  2. 2.Evaluate the acceptability of the intervention.
  3. 3.Collect preliminary outcome data on PTSD symptoms, depression, anxiety, anger, and forgiveness.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 13, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

June 3, 2009

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

March 12, 2009

Last Update Submit

June 1, 2009

Conditions

Keywords

ForgivenessWritingPTSDOEFOIFVeterans

Outcome Measures

Primary Outcomes (2)

  • TEI-SF (Treatment Evaluation Inventory-Short Form)

    One-month follow-up

  • CSQ-8 (Client Satisfaction Questionnaire)

    One-month follow-up

Secondary Outcomes (4)

  • SCID-PTSD Module

    Baseline and One-Month Follow-up

  • DASS-21 (Depression Anxiety and Stress Scales)

    Baseline, One-week Post, and One-month Follow-up

  • PCL-C (PTSD Checklist- Civilian Version)

    Baseline, One-week Post, and One-month Follow-up

  • PTCI (Posttraumatic Cognitions Inventory)

    Baseline, One-week Post, One-month Follow-up

Study Arms (1)

Forgiveness-based Writing

OTHER
Behavioral: Forgiveness-Based Writing

Interventions

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.

Forgiveness-based Writing

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Primary psychotic disorder unrelated to PTSD.
  • Impaired cognitive functioning.
  • Current suicidal or homicidal intent.
  • Symptoms meeting full PTSD diagnostic criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey Veterans Affairs Medical Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, TraumaticAnxiety DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Officials

  • Catherine R. Barber, PhD

    MIRECC Affiliate

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine R. Barber, PhD

CONTACT

Alexandra Shepherd, B.S.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

March 12, 2009

First Posted

March 13, 2009

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

June 3, 2009

Record last verified: 2009-06

Locations