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Accelerated Resolution Therapy (ART) for Psychological Trauma

This study is currently recruiting participants.
Verified March 2012 by University of South Florida
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01559688
First received: October 19, 2011
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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).

Condition Intervention
Psychological Trauma
PTSD
 Behavioral: Accelerated Resolution Therapy (ART)
Behavioral: Waitlist

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Change in PTSD Checklist (PCL-M) score from baseline to end of treatment [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
    This questionnaire asks about symptoms in response to "stressful military experiences."


Secondary Outcome Measures:
  • Change in psychological wellness as measured by Brief Symptom Inventory from baseline to endpoint [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
  • Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
  • Change in depressive symptoms as measured by CES-D from baseline to endpoint [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
  • Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
  • Change in anger as measured by Aggression Questionnaire from baseline to endpoint [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
  • Change in sleep quality as measured by PSQI from baseline to endpoint [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]
  • Change in self-compassion scale score from baseline to endpoint [ Time Frame: approximately 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 Behavioral: Waitlist
Fitness assessment or career counseling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559688

Contacts
Contact: Sue Girling, BSAS 813-974-9310 sgirling@health.usf.edu

Locations
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Sue Girling, BSAS     813-974-9310     sgirling@health.usf.edu    
Principal Investigator: Kevin Kip, PhD            
Sponsors and Collaborators
University of South Florida
Department of Defense
Investigators
Principal Investigator: Kevin Kip, PhD University of South Florida
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01559688     History of Changes
Other Study ID Numbers: TATRC-01
Study First Received: October 19, 2011
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013