Post-traumatic Stress Disorder Clinical Trial
Official title:
A Randomized Controlled Trial of Meditation Compared to Exposure Therapy and Education Control on PTSD in Veterans
The purpose of this study is to compare the effectiveness of the Transcendental Meditation (TM) program to the more standard Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) in treating posttraumatic stress disorder (PTSD) in war Veterans over a three month treatment period.
Posttraumatic stress disorder (PTSD) is a common and debilitating anxiety condition that
affects up to 20% of war Veterans. PTSD is often a chronic problem for Veterans, affecting
reintegration into society, family and marital relationships, sleep, employment stability,
substance abuse rates, and risk for depression and suicide, among other areas. Although
several effective therapies exist to treat PTSD, research shows that up to half of patients
completing these treatments continue to have elevated symptoms indicating the important need
for developing additional treatment options.
In the current trial, we propose to test one such new treatment, specifically a meditation
practice known as Transcendental Meditation. The Transcendental Meditation (TM) program will
be compared to one of the best and most standard of PTSD therapies (Prolonged Exposure
therapy), and a educational control group. This study will recruit 210 War Veterans
clinically diagnosed with PTSD from the San Diego VA Healthcare System over a 4 year study
period.
The intervention period will be 3 months. Study participants will be randomized equally to
one of three study groups, either
1. Transcendental Meditation (TM) or
2. Cognitive Behavioral Therapy with Prolonged Exposure (CBT-PE) or
3. Educational control group.
The primary outcome will be scores on the Clinically Administered PTSD Scale (CAPS).
Secondary outcomes will includes scores on PTSD symptoms including depression, anger, mood
disturbance and quality of life.
Behavioral or lifestyle factors will also be measured including smoking, alcohol, and
non-described drug usage along with compliance with each treatment.
Physiological markers of stress and disease risk will include cortisol, blood pressure,
inflammatory markers and body mass.
If successful, these research findings will serve to provide key data on the feasibility and
efficacy of the TM program as an alternative therapy for PTSD. The results will serve to
inform policy decisions on the study and application of standardized and validated stress
reduction programs in veteran populations.
;
| 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 | |
| Terminated |
NCT02234687 -
A mGlu2/3 Agonist in the Treatment of PTSD
|
Phase 1 | |
| Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
| Terminated |
NCT02520726 -
PTSD Prevention Study Examining the Efficacy of Sertraline in Burn Victims
|
Phase 4 | |
| Completed |
NCT02213900 -
Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy
|
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 |
NCT01998100 -
Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)
|
Phase 3 | |
| Completed |
NCT01199107 -
Maximizing Treatment Outcome and Examining Sleep 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 |
NCT00838006 -
Psychophysiologic Predictors of Post-deployment Mental Health Outcomes
|
N/A | |
| Completed |
NCT00348036 -
Group Intervention for Interpersonal Trauma
|
N/A | |
| Completed |
NCT00680524 -
Telephone-based Care for OEF/OIF Veterans With PTSD
|
N/A | |
| Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
| Completed |
NCT00127673 -
Comparison of Two Treatments for Post-Traumatic Stress Disorder
|
Phase 3 | |
| Completed |
NCT00183690 -
Prolonged Exposure Therapy Versus Active Psychotherapy in Treating Post-Traumatic Stress Disorder in Adolescents
|
Phase 1 |