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Accelerated Resolution Therapy (ART) for Psychological Trauma

Primary Purpose

Psychological Trauma, PTSD

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerated Resolution Therapy (ART)
Waitlist
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychological Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ART therapy group

Waitlist

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in PTSD Checklist (PCL-M) score from baseline to end of treatment
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
Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint
Change in depressive symptoms as measured by the Center for Epidemiologic Depression (CES-D) scale from baseline to endpoint
Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint
Change in anger as measured by Aggression Questionnaire from baseline to endpoint
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to endpoint
Change in self-compassion scale score from baseline to endpoint

Full Information

First Posted
October 19, 2011
Last Updated
July 27, 2020
Sponsor
University of South Florida
Collaborators
United States Department of Defense
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1. Study Identification

Unique Protocol Identification Number
NCT01559688
Brief Title
Accelerated Resolution Therapy (ART) for Psychological Trauma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
United States Department of Defense

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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: 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Trauma, PTSD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ART therapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Accelerated Resolution Therapy (ART)
Intervention Description
ART is a cognitive based therapy which integrates an eye movement technique while focusing on a problem (traumatic experience) during the therapy session.
Intervention Type
Behavioral
Intervention Name(s)
Waitlist
Intervention Description
Fitness assessment or career counseling
Primary Outcome Measure Information:
Title
Change in PTSD Checklist (PCL-M) score from baseline to end of treatment
Description
This questionnaire asks about symptoms in response to "stressful military experiences."
Time Frame
approximately 2 weeks
Secondary Outcome Measure Information:
Title
Change in psychological wellness as measured by Brief Symptom Inventory from baseline to endpoint
Time Frame
approximately 2 weeks
Title
Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint
Time Frame
approximately 2 weeks
Title
Change in depressive symptoms as measured by the Center for Epidemiologic Depression (CES-D) scale from baseline to endpoint
Time Frame
approximately 2 weeks
Title
Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint
Time Frame
approximately 2 weeks
Title
Change in anger as measured by Aggression Questionnaire from baseline to endpoint
Time Frame
approximately 2 weeks
Title
Change in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI) from baseline to endpoint
Time Frame
approximately 2 weeks
Title
Change in self-compassion scale score from baseline to endpoint
Time Frame
approximately 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Kip, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24402982
Citation
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.
Results Reference
derived
PubMed Identifier
24306011
Citation
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.
Results Reference
derived

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Accelerated Resolution Therapy (ART) for Psychological Trauma

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