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

Study Status: Enrolling by invitation
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary: 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
Sponsor: University of South Florida

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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

    Original Secondary Outcome: Same as current

    Information By: University of South Florida

    Dates:
    Date Received: November 4, 2013
    Date Started: November 2013
    Date Completion: October 2015
    Last Updated: December 18, 2014
    Last Verified: December 2014