PTSD
Conditions
Keywords
Trauma Management Therapy, Exposure Therapy, Group Therapy, PTSD, Military
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.
Interventions
BEHAVIORALExposure Therapy
Exposure Therapy is used to reduce the symptoms of PTSD
Sponsors
University of Central Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 | 1 week posttreatment | PTSD symptoms rating scale (severity and frequency) administered by blinded clinician |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | 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 |
| Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) | 1 week posttreatment | self-report measure assessing lifetime history of 22 traumatic events |
| Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) | 1 week posttreatment | 32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) |
| Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) | 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) |
| Change from Baseline on the Moral Injury Event Scale (MIES) | 1 week posttreatment | patient-report measure assessing psychological distress associated with violations of moral standards. |
| Change from baseline on the Quality of Life Scale (QOLS) | 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 |
| Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) | 1 week posttreatment | Patient report of coping ability |
| Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) | 1 week posttreatment | Patient Self Report of PTSD symptoms |
| Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) | 1 week posttreatment | Patient report measure of general anxiety symptoms |
| Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) | 1 week posttreatment | Patient report measure of anger |
| Change from baseline on the Clinical Global Impressions Scales (CGI) | 1 week posttreatment | Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change |
| Sleep actigraphy - change from baseline in total sleep time | 1 week posttreatment | Objective assessment of sleep |
| Sleep actigraphy - change from baseline in sleep onset latency | 1 week posttreatment | Objective assessment of sleep (# of minutes to sleep onset after getting into bed) |
| Sleep actigraphy - change from baseline in sleep efficiency | 1 week posttreatment | Objective assessment of sleep (% of time in bed spent sleeping) |
| Sleep actigraphy - change from baseline in wake minutes after sleep onset | 1 week posttreatment | Objective assessment of sleep (# of minutes awake after falling asleep) |
| Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) | 1 week posttreatment | Patient report measure of depression symptoms |
Countries
United States
Outcome results
None listed