Trauma Management Therapy for OEF and OIF Combat Veterans

NCT02809326 | Completed Phase 2

• 1 other identifier: UCFlorida
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will evaluate the efficacy and efficiency of Trauma Management Therapy (TMT; Frueh, Turner, Beidel, 1996; Beidel, Frueh, Uhde, under preparation), which combines individual virtual reality (VR) assisted exposure therapy with group social and emotional rehabilitation skills training (will be superior to a treatment consisting of the same VR- exposure and group psychoeducational group therapy. TMT will be conducted in traditional 17-week format, and a 3-week intensive treatment format. Outcome will be assessed using relevant clinical, process, and cost outcomes. Additionally, investigators will assess the potential of olfactory stimulation as a trigger for PTSD symptoms of intrusive thoughts and re-experiencing. Therefore, this proposal will integrate clinical and neurobiological assessment studies designed to understand the role of these factors in the etiology, maintenance, and treatment of PTSD.

Conditions

Post-Traumatic Stress Disorder; Combat Disorders

Keywords

efficiency; exposure therapy; PTSD; combat; veterans

Outcome Measures

Primary Outcomes (1)

• Clinician-Administered PTSD Scale (CAPS; Blake et al., 1990; Weathers & Litz, 1994; Weathers et al., 1999)

  PTSD Symptom Severity

  after 17 weeks for two study arms; after three weeks for the third study arm

Secondary Outcomes (7)

• Quality of Life Questionnaire (QLQ; Evans & Cope, 1989)

  after 17 weeks for two study arms; after three weeks for the third study arm

• Clinician-Administered PTSD Scale (Selected items)

  after 17 weeks for two study arms; after three weeks for the third study arm

• Objective Functional Indicators

  after 17 weeks for two study arms; after three weeks for the third study arm

• Clinical Global Impressions Scale

  after 17 weeks for two study arms; after three weeks for the third study arm

• Health-Related Functioning: Medical Outcome Study Short Form-36 Health Survey

  after 17 weeks for two study arms; after three weeks for the third study arm

Other Outcomes (2)

• Treatment Credibility

  after week 3 for 17 week arms; after third day for 3 week arm

• Charleston Psychiatric Outpatient Satisfaction Scale (CPOSS-VA; Frueh et al., 2002):

  after 17 weeks for two study arms; after three weeks for the third study arm

Study Arms (3)

17 week Trauma Management Therapy (TMT)

EXPERIMENTAL

TMTconsists of 29 treatment sessions administered over a period of 3 weeks. Individual VR-assisted exposure sessions (14 sessions) are followed by Social and Emotional Regulation (SER) sessions conducted in small groups. Individual exposure therapy includes virtual reality to assist in augmenting exposure therapy. Group therapy includes anger management, social skills training, problem solving and behavioral activation for depression. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.

Behavioral: Trauma Management Therapy

3 week Trauma Management Therapy (TMT)

EXPERIMENTAL

Intensive 3-Week Trauma Management Therapy consists of 29 treatment sessions administered over a period of 3 weeks. Individual VR-assisted exposure sessions and group sessions are conducted Monday-Friday with individual sessions conducted in the morning and Social and Emotional Regulation (SER) sessions conducted in the afternoon. Education and exposure are implemented individually while SER is administered in small group sessions (3-5 people). All exposure treatment sessions will terminate after a decline of 50% in the highest rating recorded. SER sessions will be 90 minutes. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.

Behavioral: Intensive 3-Week Trauma Management Therapy

17 week Exposure Therapy Control Arm

ACTIVE COMPARATOR

The Control Arm of the study contains 15 individual VR-assisted exposure therapy sessions and 14 psychoeducational group sessions conducted over a period of 17 weeks. After the Education session, treatment occurs three times a week during the Virtual Reality (VR) assisted Exposure phase, and then once a week during the Psychoeducational phase.The psychoeducational group therapy, will include topics such as: DSM-IV criteria of PTSD, prevalence of PTSD, risk factors for PTSD, biological and conditioning models of PTSD, PTSD comorbidity, pharmacological treatment of PTSD, the impact of substance abuse, impairment in interpersonal functioning among veterans with PTSD, and issues related to anger control problems and suggested coping strategies

Behavioral: 17 week Exposure Therapy Control Arm

Interventions

17 week Exposure Therapy Control Arm BEHAVIORAL

15 individual VR-assisted exposure therapy sessions and 14 psychoeducational group sessions conducted over a period of 17 weeks. After the Education session, treatment occurs three times a week during the Virtual Reality (VR) assisted Exposure phase, and then once a week during the Psychoeducational phase.The psychoeducational group therapy, will include topics such as: DSM-IV criteria of PTSD, prevalence of PTSD, risk factors for PTSD, biological and conditioning models of PTSD, PTSD comorbidity, pharmacological treatment of PTSD, the impact of substance abuse, impairment in interpersonal functioning among veterans with PTSD, and issues related to anger control problems and suggested coping strategies

Also known as: Exposure Therapy, Psychoeducation

17 week Exposure Therapy Control Arm

Trauma Management Therapy BEHAVIORAL

TMT consists of 29 treatment sessions administered over a period of 17 weeks. After the Education session, treatment occurs three times a week during the Virtual Reality (VR) assisted Exposure phase, and then once a week during Social and Emotional Regulation (SER). Education and exposure are implemented individually while SER is administered in small group sessions (3-5 people). All exposure treatment sessions will terminate after a decline of 50% in the highest rating recorded. SER sessions will be 90 minutes. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.

Also known as: TMT

17 week Trauma Management Therapy (TMT)

Intensive 3-Week Trauma Management Therapy BEHAVIORAL

Intensive 3-Week Trauma Management Therapy consists of 29 treatment sessions administered over a period of 3 weeks. Individual VR-assisted exposure sessions and group sessions are conducted Monday-Friday with individual sessions conducted in the morning and Social and Emotional Regulation (SER) sessions conducted in the afternoon. Education and exposure are implemented individually while SER is administered in small group sessions (3-5 people). All exposure treatment sessions will terminate after a decline of 50% in the highest rating recorded. SER sessions will be 90 minutes. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.

Also known as: Intensive TMT

3 week Trauma Management Therapy (TMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans or active duty military personnel with combat-related PTSD as a result of deployment to Iraq or Afghanistan.

You may not qualify if:

• Personnel with acute cardiac difficulties (angina, myocardial infarction, and severe hypertension) will initially be excluded from the study due to concern that intensive EXP, often accompanied by temporary increases in heart rate and blood pressure, may pose risks of exacerbating cardiac status. They will be included once they are cleared by the cardiologist.
• Because PTSD typically is accompanied by high rates of comorbid psychiatric disorders (Keane \& Wolfe, 1990), patients with comorbid depressive disorders, anxiety disorders, and personality disorders other than Antisocial Personality Disorder will be included. Also, veterans who have a diagnosis of mild Traumatic Brain Injury will be included, in order that our sample is as representative of OIF/OEF veterans as possible. We will address the issue of comorbid mTBI in the data analysis. In all cases included, PTSD must be considered the primary disorder.
• Patients must have a symptom duration of at least 6 months.

Sponsors & Collaborators

• University of Central Florida: lead

Study Sites (1)

University of Central Florida

Orlando, Florida, 32816, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Combat Disorders

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 C Beidel, Ph.D., ABPP

  University of Central Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pegasus Professor of Psychology and Medical Education Associate Chair for Research Director, UCF RESTORES

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: June 22, 2016
• Study Start: November 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

US (1)