Clinical trial NCT04549493: Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Keywords: Trauma Management Therapy
Exposure Therapy
Group Therapy
PTSD
Military
Lead sponsor: University of Central Florida
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
timeFrame: 1 week posttreatment
measure: Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
timeFrame: 3 months posttreatment
measure: Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
timeFrame: 6 months posttreatment
Secondary outcomes:
measure: Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 1 week posttreatment
measure: Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 3 months posttreatment
measure: Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
timeFrame: 6 months posttreatment
measure: Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
timeFrame: 1 week posttreatment
measure: Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
timeFrame: 3 months posttreatment
measure: Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
timeFrame: 6 months posttreatment
measure: Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
timeFrame: 1 week posttreatment
measure: Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
timeFrame: 3 months posttreatment
measure: Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
timeFrame: 6 months posttreatment
measure: Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
timeFrame: 1 week posttreatment
measure: Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
timeFrame: 3 months posttreatment
measure: Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
timeFrame: 6 months posttreatment
measure: Change from Baseline on the Moral Injury Event Scale (MIES)
timeFrame: 1 week posttreatment
measure: Change from Baseline on the Moral Injury Event Scale (MIES)
timeFrame: 3 months posttreatment
measure: Change from Baseline on the Moral Injury Event Scale (MIES)
timeFrame: 6 months posttreatment
measure: Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 1 week posttreatment
measure: Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 3 months posttreatment
measure: Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: 6 months posttreatment
measure: Change from baseline on the Quality of Life Scale (QOLS)
timeFrame: 1 week posttreatment
measure: Change from baseline on the Quality of Life Scale (QOLS)
timeFrame: 3 months posttreatment
measure: Change from baseline on the Quality of Life Scale (QOLS)
timeFrame: 6 months posttreatment
measure: Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 1 week posttreatment
measure: Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 3 months posttreatment
measure: Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: 6 months posttreatment
measure: Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 1 week posttreatment
measure: Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3 months posttreatment
measure: Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 6 months posttreatment
measure: Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 1 week posttreatment
measure: Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 3 months posttreatment
measure: Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: 6 months posttreatment
measure: Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
timeFrame: 1 week posttreatment
measure: Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
timeFrame: 3 months posttreatment
measure: Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
timeFrame: 6 months posttreatment
measure: Change from baseline on the Clinical Global Impressions Scales (CGI)
timeFrame: 1 week posttreatment
measure: Change from baseline on the Clinical Global Impressions Scales (CGI)
timeFrame: 3 months posttreatment
measure: Change from baseline on the Clinical Global Impressions Scales (CGI)
timeFrame: 6 months posttreatment
measure: Sleep actigraphy - change from baseline in total sleep time
timeFrame: 1 week posttreatment
measure: Sleep actigraphy - change from baseline in total sleep time
timeFrame: 3 months posttreatment
measure: Sleep actigraphy - change from baseline in total sleep time
timeFrame: 6 months posttreatment
measure: Sleep actigraphy - change from baseline in sleep onset latency
timeFrame: 1 week posttreatment
measure: Sleep actigraphy - change from baseline in sleep onset latency
timeFrame: 3 months posttreatment
measure: Sleep actigraphy - change from baseline in sleep onset latency
timeFrame: 6 months posttreatment
measure: Sleep actigraphy - change from baseline in sleep efficiency
timeFrame: 1 week posttreatment
measure: Sleep actigraphy - change from baseline in sleep efficiency
timeFrame: 3 months posttreatment
measure: Sleep actigraphy - change from baseline in sleep efficiency
timeFrame: 6 months posttreatment
measure: Sleep actigraphy - change from baseline in wake minutes after sleep onset
timeFrame: 1 week posttreatment
measure: Sleep actigraphy - change from baseline in wake minutes after sleep onset
timeFrame: 3 months posttreatment
measure: Sleep actigraphy - change from baseline in wake minutes after sleep onset
timeFrame: 6 months posttreatment
Other outcomes:
Locations:
city: Orlando
country: United States
facility: UCF RESTORES, University of Central Florida
state: Florida
Study officials:
affiliation: University of Central Florida
name: Deborah Beidel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: