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Clinical Trials/NCT02030522
NCT02030522CompletedNot Applicable

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

University of South Florida8 sites in 1 country155 target enrollmentStarted: November 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
155
Locations
8
Primary Endpoint
17-item PTSD Checklist-Military (PCL-M)

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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).

Arms & Interventions

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.

Intervention: Accelerated Resolution Therapy (ART) (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • State-Trait Inventory for Cognitive and Somatic Anxiety(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)
  • Medical Outcome Study Short Form-36 (SF-36)(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)
  • Brief Symptom Inventory(Change from pre-treatment to post-treatment and 6-month follow-up)
  • Pittsburgh Sleep Quality Index(Change from pre-treatment to post-treatment and 6-month follow-up)
  • Trauma-Related Guilt Inventory(Change from pre-treatment to post-treatment and 6-month follow-up)
  • Pain Outcomes Questionnaire(Change from pre-treatment to post-treatment and 6-month follow-up)
  • Psychiatric Diagnostic Screening Questionnaire(Change from pre-treatment to post-treatment and 6-month follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (8)

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