NCT01559688

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:

  1. 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. 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 29, 2020

Status Verified

October 1, 2013

Enrollment Period

2.3 years

First QC Date

October 19, 2011

Last Update Submit

July 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change in psychological wellness as measured by Brief Symptom Inventory from baseline to endpoint

    approximately 2 weeks

  • Change in trauma-related guilt as measured by Trauma-Related Guilt Inventory from baseline to endpoint

    approximately 2 weeks

  • Change in depressive symptoms as measured by the Center for Epidemiologic Depression (CES-D) scale from baseline to endpoint

    approximately 2 weeks

  • Change in anxiety symptoms as measured by State-Trait Inventory from baseline to endpoint

    approximately 2 weeks

  • Change in anger as measured by Aggression Questionnaire from baseline to endpoint

    approximately 2 weeks

  • +2 more secondary outcomes

Study Arms (2)

ART therapy group

EXPERIMENTAL

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)

Waitlist

ACTIVE COMPARATOR

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

Interventions

ART is a cognitive based therapy which integrates an eye movement technique while focusing on a problem (traumatic experience) during the therapy session.

ART therapy group
WaitlistBEHAVIORAL

Fitness assessment or career counseling

Waitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Psychological TraumaStress Disorders, Post-Traumatic

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Appointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Kevin Kip, PhD

    University of South Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2011

First Posted

March 21, 2012

Study Start

July 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 29, 2020

Record last verified: 2013-10

Locations