Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

NCT ID: NCT04549493

Last Updated: 2024-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2024-05-01

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.

Conditions

PTSD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Exposure Therapy

Intervention Type: BEHAVIORAL

Exposure Therapy is used to reduce the symptoms of PTSD

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.

Group Type: ACTIVE_COMPARATOR

Exposure Therapy

Intervention Type: BEHAVIORAL

Exposure Therapy is used to reduce the symptoms of PTSD

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.

Group Type: ACTIVE_COMPARATOR

Exposure Therapy

Intervention Type: BEHAVIORAL

Exposure Therapy is used to reduce the symptoms of PTSD

Interventions

Exposure Therapy

Exposure Therapy is used to reduce the symptoms of PTSD

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Central Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah Beidel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Central Florida

Locations

UCF RESTORES, University of Central Florida

Orlando, Florida, United States

Countries

United States

Other Identifiers

W81XWH18C0331

Identifier Type: -

Identifier Source: org_study_id