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Completed

NCT Number: NCT04549493

Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

The purpose of this requirement is to identify an effective exposure psychotherapy paradigm for the treatment of Post-Traumatic Stress Disorder (PTSD) in active duty service members and veterans by comparing different exposure psychotherapy modalities. The long-term goal of exposure psychotherapy is to improve the mental health of U.S. service members and veterans with military-related PTSD. Recovery from PTSD will reduce the economic burden not only for those persons experiencing PTSD, but also for the health care system and society as a whole (Galovski & Lyons, 2004).

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCF RESTORES, University of Central Florida

Orlando, Florida, 32816, United States

About this study

This study will provide an evaluation of performance and suitability of the compressed versions of exposure psychotherapy to support the capability gap for the treatment of active duty service members and veterans with PTSD by comparing different exposure psychotherapy modalities. The overall objective of this study is to determine if compressed psychotherapy can be used as an effective alternative treatment for PTSD and to compare the impact of TMT and PE on social, familial, and occupational impairment. The primary objectives will be to compare 1) 3 week TMT with 12 week PE and 2) 3 week TMT with 2 week PE for the effectiveness of reducing PTSD symptoms in a gated approach or some other method to control for multiplicity. Outcomes will be determined based upon self-report, clinician ratings, as well as other aspects of psychopathology, and social/emotional functioning. The addition of the TMT group component will be assessed in particular to determine its impact on social, familial, and occupational impairment. Blood samples should be collected from participants at baseline and at the end of the treatment period in order to identify PTSD biomarkers, e.g. predictors of response, biological subtypes of PTSD, and therapeutic markers. Collection, storage, and transfer of the blood samples to DoD should be performed according to standardized protocols provided by the DoD. One or more site visits may occur in order to assess adherence to standardized protocols.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Active duty military personnel with a diagnoses of PTSD
  • Traumatic event must have occurred during military service
  • Military sexual trauma limited to attempted or completed sexual assault.

Exclusion criteria

  • Acute cardiac difficulties
  • Severe comorbid substance use disorders.
  • Diagnosis of schizophrenia or other psychotic disorders
  • Diagnosis of antisocial personality disorder
  • Moderate or severe traumatic brain injury (TBI)
  • Use of benzodiazepines

Treatment and study plan

Exposure Therapy

Behavioral

Exposure Therapy is used to reduce the symptoms of PTSD

Primary outcomes

  1. Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5

    Time frame: 1 week posttreatment

    PTSD symptoms rating scale (severity and frequency) administered by blinded clinician

  2. Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5

    Time frame: 3 months posttreatment

    PTSD symptoms rating scale (severity and frequency) administered by blinded clinician

  3. Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5

    Time frame: 6 months posttreatment

    PTSD symptoms rating scale (severity and frequency) administered by blinded clinician

Secondary outcomes

  1. Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Time frame: 1 week posttreatment

    Patient Self Report of PTSD symptoms

  2. Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Time frame: 3 months posttreatment

    Patient Self Report of PTSD symptoms

  3. Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

    Time frame: 6 months posttreatment

    Patient Self Report of PTSD symptoms

  4. Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)

    Time frame: 1 week posttreatment

    self-report measure assessing lifetime history of 22 traumatic events

  5. Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)

    Time frame: 3 months posttreatment

    self-report measure assessing lifetime history of 22 traumatic events

  6. Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)

    Time frame: 6 months posttreatment

    self-report measure assessing lifetime history of 22 traumatic events

  7. Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)

    Time frame: 1 week posttreatment

    32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions)

  8. Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)

    Time frame: 3 months posttreatment

    32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions)

  9. Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)

    Time frame: 6 months posttreatment

    32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions)

  10. Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)

    Time frame: 1 week posttreatment

    36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame)

  11. Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)

    Time frame: 3 months posttreatment

    36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame)

  12. Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)

    Time frame: 6 months posttreatment

    36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame)

  13. Change from Baseline on the Moral Injury Event Scale (MIES)

    Time frame: 1 week posttreatment

    patient-report measure assessing psychological distress associated with violations of moral standards.

  14. Change from Baseline on the Moral Injury Event Scale (MIES)

    Time frame: 3 months posttreatment

    patient-report measure assessing psychological distress associated with violations of moral standards.

  15. Change from Baseline on the Moral Injury Event Scale (MIES)

    Time frame: 6 months posttreatment

    patient-report measure assessing psychological distress associated with violations of moral standards.

  16. Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: 1 week posttreatment

    patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society

  17. Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: 3 months posttreatment

    patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society

  18. Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

    Time frame: 6 months posttreatment

    patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society

  19. Change from baseline on the Quality of Life Scale (QOLS)

    Time frame: 1 week posttreatment

    Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement

  20. Change from baseline on the Quality of Life Scale (QOLS)

    Time frame: 3 months posttreatment

    Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement

  21. Change from baseline on the Quality of Life Scale (QOLS)

    Time frame: 6 months posttreatment

    Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement

  22. Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 1 week posttreatment

    Patient report of coping ability

  23. Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 3 months posttreatment

    Patient report of coping ability

  24. Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)

    Time frame: 6 months posttreatment

    Patient report of coping ability

  25. Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 1 week posttreatment

    Patient report measure of depression symptoms

  26. Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 3 months posttreatment

    Patient report measure of depression symptoms

  27. Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 6 months posttreatment

    Patient report measure of depression symptoms

  28. Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 1 week posttreatment

    Patient report measure of general anxiety symptoms

  29. Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 3 months posttreatment

    Patient report measure of general anxiety symptoms

  30. Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)

    Time frame: 6 months posttreatment

    Patient report measure of general anxiety symptoms

  31. Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)

    Time frame: 1 week posttreatment

    Patient report measure of anger

  32. Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)

    Time frame: 3 months posttreatment

    Patient report measure of anger

  33. Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)

    Time frame: 6 months posttreatment

    Patient report measure of anger

  34. Change from baseline on the Clinical Global Impressions Scales (CGI)

    Time frame: 1 week posttreatment

    Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change

  35. Change from baseline on the Clinical Global Impressions Scales (CGI)

    Time frame: 3 months posttreatment

    Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change

  36. Change from baseline on the Clinical Global Impressions Scales (CGI)

    Time frame: 6 months posttreatment

    Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change

  37. Sleep actigraphy - change from baseline in total sleep time

    Time frame: 1 week posttreatment

    Objective assessment of sleep

  38. Sleep actigraphy - change from baseline in total sleep time

    Time frame: 3 months posttreatment

    Objective assessment of sleep

  39. Sleep actigraphy - change from baseline in total sleep time

    Time frame: 6 months posttreatment

    Objective assessment of sleep

  40. Sleep actigraphy - change from baseline in sleep onset latency

    Time frame: 1 week posttreatment

    Objective assessment of sleep (# of minutes to sleep onset after getting into bed)

  41. Sleep actigraphy - change from baseline in sleep onset latency

    Time frame: 3 months posttreatment

    Objective assessment of sleep (# of minutes to sleep onset after getting into bed)

  42. Sleep actigraphy - change from baseline in sleep onset latency

    Time frame: 6 months posttreatment

    Objective assessment of sleep (# of minutes to sleep onset after getting into bed)

  43. Sleep actigraphy - change from baseline in sleep efficiency

    Time frame: 1 week posttreatment

    Objective assessment of sleep (% of time in bed spent sleeping)

  44. Sleep actigraphy - change from baseline in sleep efficiency

    Time frame: 3 months posttreatment

    Objective assessment of sleep (% of time in bed spent sleeping)

  45. Sleep actigraphy - change from baseline in sleep efficiency

    Time frame: 6 months posttreatment

    Objective assessment of sleep (% of time in bed spent sleeping)

  46. Sleep actigraphy - change from baseline in wake minutes after sleep onset

    Time frame: 1 week posttreatment

    Objective assessment of sleep (# of minutes awake after falling asleep)

  47. Sleep actigraphy - change from baseline in wake minutes after sleep onset

    Time frame: 3 months posttreatment

    Objective assessment of sleep (# of minutes awake after falling asleep)

  48. Sleep actigraphy - change from baseline in wake minutes after sleep onset

    Time frame: 6 months posttreatment

    Objective assessment of sleep (# of minutes awake after falling asleep)

Sponsors and collaborators

Lead sponsor

University of Central Florida

Other

Registry information

Official study title

Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy for the Treatment of Post-Traumatic Stress Disorder in an Active Duty Sample: A Comparison Study

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 16, 2020
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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