- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559688
Accelerated Resolution Therapy (ART) for Psychological Trauma
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:
- 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.
- Learn if there is improvement in symptoms of psychological trauma (such as bad memories, anxiety, depression, and guilt) after receiving Accelerated Resolution Therapy (ART).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33612
- University of South Florida
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ART therapy group
Participants in this arm will receive 2-5 sessions of ART therapy, depending on individual progress.
Each session will last 60-90 minutes over a 2-week period.
|
ART is a cognitive based therapy which integrates an eye movement technique while focusing on a problem (traumatic experience) during the therapy session.
|
Active Comparator: Waitlist
Participants in this group will receive 2 fitness assessment or career counseling sessions.
Each session will last 60-90 minutes over a 2-week period.
Upon completion of this arm, participants will be offered the choice to start ART therapy.
|
Fitness assessment or career counseling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PTSD Checklist (PCL-M) score from baseline to end of treatment
Time Frame: approximately 2 weeks
|
This questionnaire asks about symptoms in response to "stressful military experiences."
|
approximately 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in psychological wellness as measured by Brief Symptom Inventory from baseline to endpoint
Time Frame: approximately 2 weeks
|
approximately 2 weeks
|
Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint
Time Frame: approximately 2 weeks
|
approximately 2 weeks
|
Change in depressive symptoms as measured by the Center for Epidemiologic Depression (CES-D) scale from baseline to endpoint
Time Frame: approximately 2 weeks
|
approximately 2 weeks
|
Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint
Time Frame: approximately 2 weeks
|
approximately 2 weeks
|
Change in anger as measured by Aggression Questionnaire from baseline to endpoint
Time Frame: approximately 2 weeks
|
approximately 2 weeks
|
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to endpoint
Time Frame: approximately 2 weeks
|
approximately 2 weeks
|
Change in self-compassion scale score from baseline to endpoint
Time Frame: approximately 2 weeks
|
approximately 2 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Kip, PhD, University of South Florida
Publications and helpful links
General Publications
- Kip KE, Shuman A, Hernandez DF, Diamond DM, Rosenzweig L. Case report and theoretical description of accelerated resolution therapy (ART) for military-related post-traumatic stress disorder. Mil Med. 2014 Jan;179(1):31-7. doi: 10.7205/MILMED-D-13-00229.
- Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Sullivan KL, Long CJ, Taylor J, McGhee S, Girling SA, Wittenberg T, Sahebzamani FM, Lengacher CA, Kadel R, Diamond DM. Randomized controlled trial of accelerated resolution therapy (ART) for symptoms of combat-related post-traumatic stress disorder (PTSD). Mil Med. 2013 Dec;178(12):1298-309. doi: 10.7205/MILMED-D-13-00298.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TATRC-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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