Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma

NCT02030522 | Completed

• 1 other identifier: Pro00013717
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 8

Brief Summary

This is a prospective cohort treatment intervention study (n=200) whereby U.S. service members and veterans with symptoms of PTSD will undergo 2-5 sessions of ART delivered by Florida licensed mental health professionals trained in ART. The 3 study aims are to: (i) evaluate among U.S. service members and veterans overall, and within specific subgroups, the magnitude of change in symptoms of PTSD following treatment with ART; (ii) evaluate the sustainability of treatment response with ART; and (iii) evaluate the cost effectiveness of ART compared to prolonged exposure (PE) therapy in the treatment of symptoms of PTSD.

Conditions

Post-traumatic Stress Disorder (PTSD)

Keywords

Post-traumatic stress disorder; PTSD; Accelerated Resolution Therapy; Military; Veterans; Exposure therapy; Eye movements

Outcome Measures

Primary Outcomes (1)

• 17-item PTSD Checklist-Military (PCL-M)

  The PCL-M Checklist is a self-administered 17-item scale that corresponds to key symptoms of PTSD. Reliability estimates range from .92 to .97, and the PCL has been validated in both civilians and veterans. Respondents rate how much they were "bothered by that problem in the past month". Items are rated on a 5-point scale ranging from 1 ("not at all") to 5 ("extremely"). The PCL can be scored in several different ways. A total score (range 17-85) can be obtained by summing the scores from each of the 17 items. Cutoff scores for a probable PTSD diagnosis have been validated for some populations, but may not generalize to other populations. A second way to score the PCL is to follow the DSM-IV criteria. Strong convergent validity has been reported.

  Change from pre-treatment to post-treatment and 6-month follow-up

Secondary Outcomes (9)

• Brief Symptom Inventory

  Change from pre-treatment to post-treatment and 6-month follow-up

• Center for Epidemiological Studies Depression Scale

  Change from pre-treatment to post-treatment and 6-month follow-up

• Clinical Outcomes in Routine Evaluation

  Change from pre-treatment to post-treatment and 6-month follow-up

• Medical Outcome Study Short Form-36 (SF-36)

  Change from pre-treatment to post-treatment and 6-month follow-up

• State-Trait Inventory for Cognitive and Somatic Anxiety

  Change from pre-treatment to post-treatment and 6-month follow-up

Study Arms (1)

Prospective Treatment Cohort of ART

EXPERIMENTAL

The target population (n=200) of persons treated with the intervention, Accelerated Resolution Therapy, will consist of U.S. service members and veterans who have symptoms indicative of a current diagnosis of PTSD. No age limit or duration of symptoms of PTSD will be imposed for study eligibility, and it is anticipated that most, if not all, of eligible and enrolled participants will have had prior deployments to conflicts dating back to the 1970s, including the Vietnam War, Persian Gulf conflict, and wars in Iraq and Afghanistan. No person will be excluded on the basis of race, ethnicity, gender, or disability.

Behavioral: Accelerated Resolution Therapy (ART)

Interventions

Accelerated Resolution Therapy (ART) BEHAVIORAL

The ART protocol will be delivered in 2-5 sessions. Imaginal Exposure (IE) will be used whereby service members and veterans will be asked to recall (verbally or non-verbally) details of the traumatic event(s) while focusing their attention on physiological sensations, thoughts, and emotions. This short period of exposure to the memory will be followed by identification and diminishment of the emergence of any uncomfortable emotional or somatic symptoms. Imagery Rescripting (IR) will be used to change (replace) negative traumatic images to positive images. The service member/veteran will imagine and play out an affectively-driven solution to change sensory components of the memory, as if they were the "director of the movie" of the memory they are working on.

Prospective Treatment Cohort of ART

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• U.S. service member or veteran with prior deployment(s) to a major conflict zone(s)(e.g. Vietnam War, Persian Gulf conflict, and wars in Iraq and Afghanistan).
• Symptoms indicative of current PTSD. This includes: (i) score of \>40 on the PCL-M Checklist; (ii) endorsement of PCL-M symptoms rated as "Moderately" or above as follows: at least 1 B item (questions 1-5), 3 C items (questions 6-12), and at least 2 D items (questions 13-17); and (iii) scoring positive on the PTSD subscale of the Psychiatric Diagnostic Screening Questionnaire.
• 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.
• Currently engaged in another PTSD psychotherapy treatment intervention. Screening therapist will determine eligibility based on the type of psychotherapy and medications the participant is receiving.
• Major psychiatric disorder (e.g. bipolar disorder) concomitant to symptoms of psychological trauma and deemed likely to interfere with treatment delivery.
• Currently undergoing substance abuse treatment (alcohol and/or drug).
• Any medical condition that, in the judgment of the Principal Investigator and/or ART clinician, may place the individual at high risk due to a potential heightened emotional reaction (e.g. previous heart attack, seizure disorder).

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (8)

Homeless Emergency Project (HEP)

Clearwater, Florida, 33755, United States

Location

Veterans Alternative Therapy Center

Holiday, Florida, United States

Location

Life Renewal Counseling

Jupiter, Florida, 33578, United States

Location

Pasco County Detention Center

Land O' Lakes, Florida, 34637, United States

Location

Supportive Services for Veterans Families

New Port Richey, Florida, United States

Location

Gilstrap & Associates

Orlando, Florida, 32835, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Cornerstone Counseling

Auburn, Maine, United States

Location

Related Publications (4)

• Kip KE, Sullivan KL, Lengacher CA, Rosenzweig L, Hernandez DF, Kadel R, Kozel FA, Shuman A, Girling SA, Hardwick MJ, Diamond DM. Brief treatment of co-occurring post-traumatic stress and depressive symptoms by use of accelerated resolution therapy((R)). Front Psychiatry. 2013 Mar 8;4:11. doi: 10.3389/fpsyt.2013.00011. eCollection 2013.

  PMID: 23482431 BACKGROUND

• Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Diamond DM, Girling SA, Sullivan KL, Wittenberg T, Witt AM, Lengacher CA, Anderson B, McMillan SC. Accelerated Resolution Therapy for treatment of pain secondary to symptoms of combat-related posttraumatic stress disorder. Eur J Psychotraumatol. 2014 May 7;5. doi: 10.3402/ejpt.v5.24066. eCollection 2014.

  PMID: 24959325 BACKGROUND

• 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.

  PMID: 24402982 BACKGROUND

• 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.

  PMID: 24306011 BACKGROUND

Related Links

• Huffington Post Commentary on Accelerated Resolution Therapy

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Kevin E Kip, Ph.D.

  University of South Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2013
• First Posted: January 8, 2014
• Study Start: November 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 28, 2020

Record last verified: 2014-12

Locations

US (8)