Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

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

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).

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: Exposure Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32816
      • UCF RESTORES, University of Central Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Trauma Management Therapy; 1. Trauma Management Therapy (TMT; Turner, Beidel, & Frueh, 2005): TMT is a multicomponent behavioral treatment program designed to target various aspects of chronic PTSD - reducing emotional and physiological reactivity to traumatic cues, reducing intrusive symptoms and avoidance behavior, improving interpersonal skills and emotion modulation (e.g., anger control), and increasing the range of enjoyable social activities. In this investigation and in line with our previous publications, TMT will include virtual-reality augmented exposure (i.e. olfactory stimulation, heart rate, and skin conductance); group therapy to address sleep, anger, depression, and social isolation; homework assignments; and programmed practice. In the 3-week treatment program, each participant receives virtual-reality assisted exposure in the morning followed by in vivo exposure and group therapy (SER) each afternoon for a total of 29 sessions.	Behavioral: Exposure Therapy; Exposure Therapy is used to reduce the symptoms of PTSD
Active Comparator: Prolonged Exposure; 2. Standard Prolonged Exposure (PE; Foa, Hembree, & Rothbaum, 2007) consists of psychoeducation, imaginal exposure to trauma memories, in vivo exposure to situations that are avoided due to their association with the trauma, and emotional processing. The standard protocol consists of 12 imaginal exposure sessions, along with in vivo exposure/homework assignments and listening to a recording of the imaginal sessions at home during the evening.	Behavioral: Exposure Therapy; Exposure Therapy is used to reduce the symptoms of PTSD
Active Comparator: Compressed Prolonged Exposure; 3. Compressed PE consists of 10 standard PE sessions delivered on consecutive work days. The imaginal exposure sessions take place in the morning, with in vivo exposures assigned (not therapist accompanied) for the afternoons. Patients are instructed to listen to the recordings of the imaginal exposure each night. Being most concerned with having enough time for in vivo practice, Session 1 does not start on a Monday, allowing for two full weekends in order to maximize in vivo exposures. Both versions of PE average 36 total treatment hours.	Behavioral: Exposure Therapy; Exposure Therapy is used to reduce the symptoms of PTSD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Patient Self Report of PTSD symptoms	1 week posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Patient Self Report of PTSD symptoms	3 months posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)	Patient Self Report of PTSD symptoms	6 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)	self-report measure assessing lifetime history of 22 traumatic events	1 week posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)	self-report measure assessing lifetime history of 22 traumatic events	3 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)	self-report measure assessing lifetime history of 22 traumatic events	6 months posttreatment
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)	Patient report of coping ability	1 week posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)	Patient report of coping ability	3 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)	Patient report of coping ability	6 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)	Patient report measure of depression symptoms	1 week posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)	Patient report measure of depression symptoms	3 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)	Patient report measure of depression symptoms	6 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)	Patient report measure of general anxiety symptoms	1 week posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)	Patient report measure of general anxiety symptoms	3 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)	Patient report measure of general anxiety symptoms	6 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)	Patient report measure of anger	1 week posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)	Patient report measure of anger	3 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)	Patient report measure of anger	6 months posttreatment
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
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
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
Sleep actigraphy - change from baseline in total sleep time	Objective assessment of sleep	1 week posttreatment
Sleep actigraphy - change from baseline in total sleep time	Objective assessment of sleep	3 months posttreatment
Sleep actigraphy - change from baseline in total sleep time	Objective assessment of sleep	6 months posttreatment
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
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
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
Sleep actigraphy - change from baseline in sleep efficiency	Objective assessment of sleep (% of time in bed spent sleeping)	1 week posttreatment
Sleep actigraphy - change from baseline in sleep efficiency	Objective assessment of sleep (% of time in bed spent sleeping)	3 months posttreatment
Sleep actigraphy - change from baseline in sleep efficiency	Objective assessment of sleep (% of time in bed spent sleeping)	6 months posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset	Objective assessment of sleep (# of minutes awake after falling asleep)	1 week posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset	Objective assessment of sleep (# of minutes awake after falling asleep)	3 months posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset	Objective assessment of sleep (# of minutes awake after falling asleep)	6 months posttreatment

Collaborators and Investigators

• Sponsor: University of Central Florida
• Investigators: Principal Investigator: Deborah Beidel, Ph.D., University of Central Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: PTSD; Military; Group Therapy; Exposure Therapy; Trauma Management Therapy
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: W81XWH18C0331

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No