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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2013
Source University of South Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Accelerated Resolution Therapy (ART)
ART is a cognitive based therapy which integrates an eye movement technique while focusing on a problem (traumatic experience) during the therapy session.
Waitlist
Fitness assessment or career counseling

Locations

Country Name City State
United States University of South Florida Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
University of South Florida United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

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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