PTSD Clinical Trial - Effectiveness of Trauma Management Therapy &

Status Completed

Clinical Trial 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).

Clinical Trial 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 Design

Related Conditions & MeSH terms

PTSD

Clinical Trial Details

NCT number	NCT04549493
Study type	Interventional
Source	University of Central Florida
Contact
Status	Completed
Phase	N/A
Start date	February 12, 2020
Completion date	May 1, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03962504` - Written Exposure Therapy Versus Prolonged Exposure: a Non-inferiority Trial	N/A
Completed	`NCT01995123` - Behavioral Activation for Smoking Cessation in PTSD	N/A
Not yet recruiting	`NCT06278922` - Evaluating Signs of Safety: A Deaf-Accessible Therapy Toolkit for AUD and Trauma	N/A
Completed	`NCT04597450` - Lu AG06466 in Participants With Post Traumatic Stress Disorder (PTSD)	Phase 1
Completed	`NCT03593772` - Mission Reconnect- Delivering a Mobile and Web Based Self Directed Complementary And Integrative Health Program to Veterans and Their Partners to Manage Pain and PTSD	N/A
Completed	`NCT03429166` - Connecting Women to Care: Home-based Psychotherapy for Women With MST Living in Rural Areas	N/A
Recruiting	`NCT04317820` - Deep Brain Reorienting in Post-traumatic Stress Disorder	N/A
Active, not recruiting	`NCT04588883` - Strengthening Families Living With HIV in Kenya	N/A
Completed	`NCT03504722` - Evaluating the Feasibility of RESCUE: An Adjunctive HAI-Based Intervention for Veterans With PTSD	N/A
Completed	`NCT04305353` - Intensive Care Unit (ICU) Diary Project	N/A
Completed	`NCT03113890` - McLean and Genomind Prospective Study	N/A
Withdrawn	`NCT05173831` - Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans	Phase 2
Not yet recruiting	`NCT04056767` - Changes in Digital Phenotype During PE Therapy
Withdrawn	`NCT03924297` - Chilipad for Sleep and Symptoms of PTSD	N/A
Withdrawn	`NCT03216356` - Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD	Phase 2/Phase 3
Completed	`NCT03343028` - Biomarker Establishment for Superior Treatment of PTSD
Completed	`NCT03158558` - Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD	N/A
Completed	`NCT02370173` - A Non-Pharmacological Method for Enhancing Sleep in PTSD	N/A
Completed	`NCT01955538` - The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees.	Phase 3
Withdrawn	`NCT01957371` - Mindful Yoga Therapy for Veterans With PTSD and Pain	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms