Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

NCT04549493 | Completed DMC

• 1 other identifier: W81XWH18C0331
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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).

Conditions

PTSD

Keywords

Trauma Management Therapy; Exposure Therapy; Group Therapy; PTSD; Military

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (48)

• Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  1 week posttreatment

• Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  3 months posttreatment

• Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)

  6 months posttreatment

• Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)

  1 week posttreatment

• Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)

  3 months posttreatment

Study Arms (3)

Trauma Management Therapy

ACTIVE COMPARATOR

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

Prolonged Exposure

ACTIVE COMPARATOR

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

Compressed Prolonged Exposure

ACTIVE COMPARATOR

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

Interventions

Exposure Therapy BEHAVIORAL

Exposure Therapy is used to reduce the symptoms of PTSD

Compressed Prolonged Exposure; Prolonged Exposure; Trauma Management Therapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

UCF RESTORES, University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Implosive Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Deborah Beidel, Ph.D.

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: September 16, 2020
• Study Start: February 12, 2020
• Primary Completion: December 20, 2023
• Study Completion: May 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)