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

July 27, 2020 updated by: University of South Florida
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study entitled "Prospective Cohort Study of Accelerated Resolution Therapy (ART) for Treatment of Military Psychological Trauma" 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. Clinical assessments will be conducted pre-treatment, post-treatment (approximately 2 weeks after study entry), and at 6-month follow-up (self-report questionnaires). The study aligns with the USF College of Nursing POWER initiative by seeking to expand the science base of effective treatment of service members and veterans with impaired psychological status. The study rationale is to: (i) demonstrate that ART is a brief, effective, and safe treatment for military-related PTSD including military sexual trauma (MST) and among service members with PTSD refractory to previous psychotherapy; (ii) provide evidence of the sustainability of clinical response 6-months after treatment completion; (iii) provide evidence that ART is a cost effective treatment for PTSD compared to current therapies formally endorsed by the VA and DoD; and (iv) develop the infrastructure for expansion of the ART protocol and science base, including national and international treatment settings, expanded patient populations, expanded clinical services, and mechanistic studies of ART. The target population (n=200) will consist of U.S. service members and veterans who have symptoms indicative of a current diagnosis of PTSD. Oversampling will occur for participants with a history of MST (minimum n=60) and/or PTSD refractory to prior psychotherapy (minimum n=60). 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 War, and the more recent wars in Iraq and Afghanistan. Demographic and medical history data will be collected along with details of prior military service including service branch, deployment location(s) and type of trauma(s). Participants will complete the 7-item Combat Exposure Scale and 3-item Brief Traumatic Brain Injury Screen. To evaluate treatment response, measures completed at entry, post-treatment, and 6 months will include: 17-item PCL-M (PTSD Checklist), 125-item Psychiatric Diagnostic Screening Questionnaire, 18-item Brief Symptom Inventory (BSI), 34-item Clinical Outcomes in Routine Evaluation (CORE-OM) scale, Medical Outcome Study Short Form-36, 20-item Center for Epidemiological Studies Depression Scale (CES-D), 21-item State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA), 22-item Trauma-Related Guilt Inventory (TRGI), and use of medications. The study will be conducted over a 24-month period.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Clearwater, Florida, United States, 33755
        • Homeless Emergency Project (HEP)
      • Holiday, Florida, United States
        • Veterans Alternative Therapy Center
      • Jupiter, Florida, United States, 33578
        • Life Renewal Counseling
      • Land O' Lakes, Florida, United States, 34637
        • Pasco County Detention Center
      • New Port Richey, Florida, United States
        • Supportive Services for Veterans Families
      • Orlando, Florida, United States, 32835
        • Gilstrap & Associates
      • Tampa, Florida, United States, 33612
        • University of South Florida
    • Maine
      • Auburn, Maine, United States
        • Cornerstone Counseling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prospective Treatment Cohort of ART
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
17-item PTSD Checklist-Military (PCL-M)
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brief Symptom Inventory
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 18-item Brief Symptom Inventory (BSI) is a shortened version of the Symptom Checklist 90-Revised (SCL-R-90) designed to measure clinically relevant psychological symptoms in adolescents and adults. This instrument encompasses 3 factors: Somatization, Depression, and Anxiety, along with a Global Severity Index. This inventory shows satisfactory reliability indexes, both for the individual factors (ranging from 0.74 to 0.84) and the Global Severity Index (0.89).
Change from pre-treatment to post-treatment and 6-month follow-up
Center for Epidemiological Studies Depression Scale
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 20-item Centers for Epidemiological Studies Depression Scale (CES-D) is a widely used self-report scale that measures current level of depressive symptomatology with an emphasis on depressed mood during the past week. The CES-D incorporates the main symptoms of depression and was derived from five validated depression scales including the Beck Depression Inventory (BDI). It is freely available in the public domain, has been validated in community and primary care populations, and has good test-retest reliability (range 0.84 to 0.92).
Change from pre-treatment to post-treatment and 6-month follow-up
Clinical Outcomes in Routine Evaluation
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 34-item Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM) is a generic measure of psychological distress, which is pan-theoretical (i.e., not associated with a school of therapy), pan-diagnostic (i.e. not focused on a single presenting problem), and draws upon the views of what practitioners consider to be the most important generic aspects of psychological well-being health to measure. The CORE-OM comprises 4 domains: well-being (4 items), symptoms (12 items), functioning (12 items), and risk (6 items). Internal consistency coefficients range from 0.70 to 0.97 across all domains and among primary and secondary care settings.
Change from pre-treatment to post-treatment and 6-month follow-up
Medical Outcome Study Short Form-36 (SF-36)
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The Medical Outcome Study Short Form-36 (SF-36) is an established, widely used measure for constructing a health utility index. It is a self-report 36-item health status measure that uses a Likert-type response format. The eight subscales of SF-36 include the domains of role limitations with regard to physical health, emotional health, energy/fatigue, emotional well-being, social functioning, pain, and general health, along with a general scale on physical functioning. Subscale scores range from 0 to 100 with higher scores indicating a more favorable health status. Estimates of internal consistency reliability range from 0.62 to 0.94; the majority of scores have exceeded 0.80. Test-retest reliability estimates range from 0.43 to 0.90. Factor analysis indicates two dimensions of the instrument, physical and mental health status, that account for 82% of the reliable variance of the measure.
Change from pre-treatment to post-treatment and 6-month follow-up
State-Trait Inventory for Cognitive and Somatic Anxiety
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 21-item State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) is designed to assess cognitive and somatic symptoms of anxiety as they pertain to one's mood in the moment (state) and in general (trait). It takes an estimated 6 minutes to complete. The STICSA is a reliable and valid measure of state and trait cognitive and somatic anxiety, with coefficients ranging from 0.87 to 0.90.
Change from pre-treatment to post-treatment and 6-month follow-up
Pittsburgh Sleep Quality Index
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 15-item Pittsburgh Sleep Quality Index (PSQI) measures quality and patterns of sleep in adults. It takes an estimated 3 to 6 minutes to complete. A global PSQI score greater than 5 has yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p<0.001) in distinguishing good and poor sleepers. Internal consistency reliability has been estimated to range from .77 to .81.
Change from pre-treatment to post-treatment and 6-month follow-up
Trauma-Related Guilt Inventory
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 22-item Trauma Related Guilt Inventory (TRGI) assesses event-focused, trauma-related guilt. The inventory has high internal consistency and adequate temporal stability, and its scales and subscales significantly correlate with measures of guilt and PTSD, depression, and adjustment. Reliability coefficients range from 0.73 to 0.91. The time to complete the inventory is estimated to be 6 minutes.
Change from pre-treatment to post-treatment and 6-month follow-up
Pain Outcomes Questionnaire
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 20-item Pain Outcomes Questionnaire (POQ) - Short Form is a reliable and valid instrument that contains 19 primary pain items that are rated on an 11-point (0-10) Likert-type scale and one demographic question. In addition to a total pain score, six subscale scores can be calculated that correspond to: pain intensity (1 item), pain-related impairment in mobility (4 items), pain-related impairment in performing activities of daily living (4 items), sense of impairment in activity and energy levels (3 items), dysphoric affect and associated symptoms (5 items), and pain-related fear and avoidance (2 items).
Change from pre-treatment to post-treatment and 6-month follow-up
Psychiatric Diagnostic Screening Questionnaire
Time Frame: Change from pre-treatment to post-treatment and 6-month follow-up
The 125-item Psychiatric Diagnostic Screening Questionnaire (PDSQ) is used to screen for Axis I disorders and global assessment of psychopathology. This instrument has been validated against diagnostic criteria and interview-derived diagnoses over the course of 10 years and more than 3,000 administrations. It can be quickly hand scored to obtain a total score (which functions as a global indicator of psychopathology) plus subscale scores for 13 disorders: major depressive disorder (MDD), generalized anxiety disorder, panic disorder, PTSD, alcohol abuse/dependence, drug abuse/dependence, psychosis, bulimia/binge-eating disorder, somatization disorder, obsessive-compulsive disorder, social phobia, hypochondriasis, and agoraphobia.
Change from pre-treatment to post-treatment and 6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of South Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin E Kip, Ph.D., University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00013717

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