Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

May 9, 2024 updated by: University of Central Florida

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
1 week posttreatment
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 months posttreatment
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
6 months posttreatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
1 week posttreatment
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 months posttreatment
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
6 months posttreatment
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
1 week posttreatment
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
3 months posttreatment
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
6 months posttreatment
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)
1 week posttreatment
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)
3 months posttreatment
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)
6 months posttreatment
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)
1 week posttreatment
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)
3 months posttreatment
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)
6 months posttreatment
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.
1 week posttreatment
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.
3 months posttreatment
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.
6 months posttreatment
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
1 week posttreatment
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
3 months posttreatment
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
6 months posttreatment
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
1 week posttreatment
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
3 months posttreatment
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
6 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: 1 week posttreatment
Patient report of coping ability
1 week posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: 3 months posttreatment
Patient report of coping ability
3 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Time Frame: 6 months posttreatment
Patient report of coping ability
6 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 1 week posttreatment
Patient report measure of depression symptoms
1 week posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 3 months posttreatment
Patient report measure of depression symptoms
3 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 6 months posttreatment
Patient report measure of depression symptoms
6 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 1 week posttreatment
Patient report measure of general anxiety symptoms
1 week posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 3 months posttreatment
Patient report measure of general anxiety symptoms
3 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: 6 months posttreatment
Patient report measure of general anxiety symptoms
6 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Time Frame: 1 week posttreatment
Patient report measure of anger
1 week posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Time Frame: 3 months posttreatment
Patient report measure of anger
3 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Time Frame: 6 months posttreatment
Patient report measure of anger
6 months posttreatment
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
1 week posttreatment
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
3 months posttreatment
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
6 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Time Frame: 1 week posttreatment
Objective assessment of sleep
1 week posttreatment
Sleep actigraphy - change from baseline in total sleep time
Time Frame: 3 months posttreatment
Objective assessment of sleep
3 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Time Frame: 6 months posttreatment
Objective assessment of sleep
6 months posttreatment
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)
1 week posttreatment
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)
3 months posttreatment
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)
6 months posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Time Frame: 1 week posttreatment
Objective assessment of sleep (% of time in bed spent sleeping)
1 week posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Time Frame: 3 months posttreatment
Objective assessment of sleep (% of time in bed spent sleeping)
3 months posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Time Frame: 6 months posttreatment
Objective assessment of sleep (% of time in bed spent sleeping)
6 months posttreatment
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)
1 week posttreatment
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)
3 months posttreatment
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)
6 months posttreatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Central Florida

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Deborah Beidel, Ph.D., University of Central Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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