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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04549493
Other study ID # W81XWH18C0331
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 12, 2020
Est. completion date May 2024

Study information

Verified date November 2022
Source University of Central Florida
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 300
Est. completion date May 2024
Est. primary completion date December 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 64 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Exposure Therapy
Exposure Therapy is used to reduce the symptoms of PTSD

Locations

Country Name City State
United States UCF RESTORES, University of Central Florida Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Central Florida

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 PTSD symptoms rating scale (severity and frequency) administered by blinded clinician 1 week posttreatment
Primary Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 PTSD symptoms rating scale (severity and frequency) administered by blinded clinician 3 months posttreatment
Primary Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5 PTSD symptoms rating scale (severity and frequency) administered by blinded clinician 6 months posttreatment
Secondary Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Patient Self Report of PTSD symptoms 1 week posttreatment
Secondary Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Patient Self Report of PTSD symptoms 3 months posttreatment
Secondary Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Patient Self Report of PTSD symptoms 6 months posttreatment
Secondary Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) self-report measure assessing lifetime history of 22 traumatic events 1 week posttreatment
Secondary Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) self-report measure assessing lifetime history of 22 traumatic events 3 months posttreatment
Secondary Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ) self-report measure assessing lifetime history of 22 traumatic events 6 months posttreatment
Secondary Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) 32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) 1 week posttreatment
Secondary Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) 32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) 3 months posttreatment
Secondary Change from Baseline on the Trauma-Related Guilt Inventory (TRGI) 32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions) 6 months posttreatment
Secondary Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) 36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) 1 week posttreatment
Secondary Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) 36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) 3 months posttreatment
Secondary Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI) 36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame) 6 months posttreatment
Secondary Change from Baseline on the Moral Injury Event Scale (MIES) patient-report measure assessing psychological distress associated with violations of moral standards. 1 week posttreatment
Secondary Change from Baseline on the Moral Injury Event Scale (MIES) patient-report measure assessing psychological distress associated with violations of moral standards. 3 months posttreatment
Secondary Change from Baseline on the Moral Injury Event Scale (MIES) patient-report measure assessing psychological distress associated with violations of moral standards. 6 months posttreatment
Secondary Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 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 1 week posttreatment
Secondary Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 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 3 months posttreatment
Secondary Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 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 6 months posttreatment
Secondary Change from baseline on the Quality of Life Scale (QOLS) 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 1 week posttreatment
Secondary Change from baseline on the Quality of Life Scale (QOLS) 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 3 months posttreatment
Secondary Change from baseline on the Quality of Life Scale (QOLS) 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 6 months posttreatment
Secondary Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) Patient report of coping ability 1 week posttreatment
Secondary Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) Patient report of coping ability 3 months posttreatment
Secondary Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC) Patient report of coping ability 6 months posttreatment
Secondary Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) Patient report measure of depression symptoms 1 week posttreatment
Secondary Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) Patient report measure of depression symptoms 3 months posttreatment
Secondary Change from baseline on the Patient Health Questionnaire-9 (PHQ-9) Patient report measure of depression symptoms 6 months posttreatment
Secondary Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) Patient report measure of general anxiety symptoms 1 week posttreatment
Secondary Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) Patient report measure of general anxiety symptoms 3 months posttreatment
Secondary Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7) Patient report measure of general anxiety symptoms 6 months posttreatment
Secondary Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) Patient report measure of anger 1 week posttreatment
Secondary Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) Patient report measure of anger 3 months posttreatment
Secondary Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5) Patient report measure of anger 6 months posttreatment
Secondary Change from baseline on the Clinical Global Impressions Scales (CGI) Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change 1 week posttreatment
Secondary Change from baseline on the Clinical Global Impressions Scales (CGI) Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change 3 months posttreatment
Secondary Change from baseline on the Clinical Global Impressions Scales (CGI) Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change 6 months posttreatment
Secondary Sleep actigraphy - change from baseline in total sleep time Objective assessment of sleep 1 week posttreatment
Secondary Sleep actigraphy - change from baseline in total sleep time Objective assessment of sleep 3 months posttreatment
Secondary Sleep actigraphy - change from baseline in total sleep time Objective assessment of sleep 6 months posttreatment
Secondary Sleep actigraphy - change from baseline in sleep onset latency Objective assessment of sleep (# of minutes to sleep onset after getting into bed) 1 week posttreatment
Secondary Sleep actigraphy - change from baseline in sleep onset latency Objective assessment of sleep (# of minutes to sleep onset after getting into bed) 3 months posttreatment
Secondary Sleep actigraphy - change from baseline in sleep onset latency Objective assessment of sleep (# of minutes to sleep onset after getting into bed) 6 months posttreatment
Secondary Sleep actigraphy - change from baseline in sleep efficiency Objective assessment of sleep (% of time in bed spent sleeping) 1 week posttreatment
Secondary Sleep actigraphy - change from baseline in sleep efficiency Objective assessment of sleep (% of time in bed spent sleeping) 3 months posttreatment
Secondary Sleep actigraphy - change from baseline in sleep efficiency Objective assessment of sleep (% of time in bed spent sleeping) 6 months posttreatment
Secondary Sleep actigraphy - change from baseline in wake minutes after sleep onset Objective assessment of sleep (# of minutes awake after falling asleep) 1 week posttreatment
Secondary Sleep actigraphy - change from baseline in wake minutes after sleep onset Objective assessment of sleep (# of minutes awake after falling asleep) 3 months posttreatment
Secondary Sleep actigraphy - change from baseline in wake minutes after sleep onset Objective assessment of sleep (# of minutes awake after falling asleep) 6 months posttreatment
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