Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress

Status Completed

Clinical Trial Summary

This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of post-traumatic stress disorder in people who have survived a traumatic injury.

Clinical Trial Description

Approximately 2.5 million people in the U.S. are hospitalized each year having sustained injuries during a traumatic event. Injured trauma survivors are at high risk for developing post-traumatic stress disorder (PTSD) and other related conditions. In addition, many of these people experience several physical, financial, social, legal, and medical problems over the course of the year following the trauma. Effective interventions to prevent or remedy these issues have yet to be developed for individuals who undergo inpatient surgery following a traumatic injury and who then continue with outpatient treatment and community rehabilitation. This study will evaluate the effectiveness of patient-centered collaborative care that combines behavioral therapy and drug therapy as compared to usual care in reducing symptoms of PTSD and substance use. The study will also assess the intervention's effectiveness in increasing participants' general functioning and satisfaction with their care post-injury. Participants in this open label study will be randomly assigned to receive either the standard care provided to injured trauma survivors or a combination of behavioral therapy and drug therapy. Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine; sertraline; paroxetine; buspirone; propranolol; trazodone; and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Behavioral therapy will also be administered on the basis of the participants' individual needs and may continue for up to 12 months. Participants will also take part in motivational interviews, the first of which will be conducted upon study entry in the hospital ward. Subsequent interviews will be conducted over the phone at Months 1, 3, 6, 9, and 12. Participants will be required to report to the study site only for the initial baseline visit. Outcome measures will include PTSD severity ratings, frequency of substance use, and general functioning reports. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00270959
Study type	Interventional
Source	University of Washington
Contact
Status	Completed
Phase	Phase 1
Start date	June 2006
Completion date	March 2013

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04317820` - Deep Brain Reorienting in Post-traumatic Stress Disorder	N/A
Completed	`NCT05112003` - Translingual Neurostimulation for the Virtual Treatment of Post-Traumatic Stress Disorder: A Feasibility Pilot	N/A
Recruiting	`NCT04518267` - Anger and Psychotrauma: Data From Military and Civilians
Completed	`NCT02502604` - Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder	N/A
Completed	`NCT02256566` - Cognitive Training for Mood and Anxiety Disorders	N/A
Terminated	`NCT02234687` - A mGlu2/3 Agonist in the Treatment of PTSD	Phase 1
Completed	`NCT02213900` - Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy	Phase 4
Terminated	`NCT02520726` - PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims	Phase 4
Completed	`NCT01738308` - The Effects of Healing Touch on Post Operative Pediatric Patients	N/A
Completed	`NCT01517711` - Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)	Phase 4
Completed	`NCT01437891` - Sentra AM® and Sentra PM® for Post-traumatic Stress Disorder (PTSD) and Gulf War Fibromyalgia (GWF)	N/A
Completed	`NCT01199107` - Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)	Phase 3
Completed	`NCT01998100` - Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)	Phase 3
Completed	`NCT01231711` - Improving Quality-of-life and Depressive Symptoms of Combat Veterans Via Internet-based Intervention	Phase 1
Completed	`NCT00680524` - Telephone-based Care for OEF/OIF Veterans With PTSD	N/A
Completed	`NCT00348036` - Group Intervention for Interpersonal Trauma	N/A
Completed	`NCT00838006` - Psychophysiologic Predictors of Post-deployment Mental Health Outcomes	N/A
Completed	`NCT00525226` - Evaluating the Effects of Stress in Pregnancy	N/A
Completed	`NCT00183690` - Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents	Phase 1
Completed	`NCT00127673` - Comparison of Two Treatments for Post-Traumatic Stress Disorder	Phase 3

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.

Patient-Centered Collaborative Care for Preventing Post-Traumatic Stress Disorder After Traumatic Injury — TSOS II

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms