PTSD Clinical Trial
NCT number | NCT01559688 |
Other study ID # | TATRC-01 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2011 |
Est. completion date | October 2013 |
Verified date | October 2013 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Service members and veterans often experience symptoms of psychological trauma following
combat deployments. While efforts are being made in the military and at the Veteran's Affairs
to meet the large number of soldiers and veterans experiencing symptoms of psychological
trauma, there remains a need to evaluate new treatments, particularly those that are designed
to be brief in length.
A new therapy, known as Accelerated Resolution Therapy (ART), is a type of psychological
therapy that is designed for rapid resolution of symptoms of psychological trauma. This
approach uses a combination of talking and sets of eye movements guided by the therapist.
During therapy, this interactive personal guidance is thought to be helpful in resolving
problems (such as bad memories).
The purpose of this study is to:
1. Evaluate how effective ART is in treating symptoms of psychological trauma among
non-active duty veterans who served in Operation Iraqi Freedom and Operation Enduring
Freedom in Iraq and in Afghanistan or other combat conflicts.
2. Learn if there is improvement in symptoms of psychological trauma (such as bad memories,
anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).
Status | Completed |
Enrollment | 63 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Non-active duty U.S. veteran of any prior deployment(s) with recruitment emphasis on those who previously served in Iraq and/or Afghanistan (OIF and OEF). - At least 18 years of age. - Symptoms indicative of psychological trauma. This includes a score of >40 on the PCL-M Checklist, or in the absence of a score >40, therapist assessment of symptoms of PTSD, as determined from the Checklist for Accelerated Resolution Therapy (ART) Standard Protocol. Individuals with previous treatment for psychological trauma, yet with residual symptoms, will be eligible. - Ability to read and speak English to complete survey questions. - Denial of suicidal ideation or intent, including homicidal ideation or intent, and no evidence of psychotic behavior or being in psychological crisis Exclusion Criteria: - Brain injury prohibiting speech, writing, and purposeful actions - Identified to have current suicidal ideation - Major psychiatric disorder concomitant to symptoms of psychological trauma - Currently undergoing substance abuse treatment - Previous diagnosis of eye movement disorder - Any medical condition that, in the judgment of the Principal Investigator and/or ART therapist, may place the individual at high risk due to a potential heightened emotional reaction |
Country | Name | City | State |
---|---|---|---|
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in PTSD Checklist (PCL-M) score from baseline to end of treatment | This questionnaire asks about symptoms in response to "stressful military experiences." | approximately 2 weeks | |
Secondary | Change in psychological wellness as measured by Brief Symptom Inventory from baseline to endpoint | approximately 2 weeks | ||
Secondary | Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint | approximately 2 weeks | ||
Secondary | Change in depressive symptoms as measured by the Center for Epidemiologic Depression (CES-D) scale from baseline to endpoint | approximately 2 weeks | ||
Secondary | Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint | approximately 2 weeks | ||
Secondary | Change in anger as measured by Aggression Questionnaire from baseline to endpoint | approximately 2 weeks | ||
Secondary | Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to endpoint | approximately 2 weeks | ||
Secondary | Change in self-compassion scale score from baseline to endpoint | approximately 2 weeks |
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