Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)

Completed · Phase 3

Conditions studied: Post-Traumatic Stress Disorder

In brief

The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition, the two strategies (i.e., exercise and wellness education) will be compared in terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptom PTSD improvement.

Key facts

Study ID

NCT01199107

Run by

Southern Methodist University

People needed

9

Starts

2010-09-01

Expected to finish

2013-08-01

Last updated by the study team

2014-12-10

Who can join

Age: 18 and older, up to 54. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• You have PTSD
• You are between the age of 18 and 54 if female or between ages 18 and 44 if male.
• You have written physician approval/medical clearance to participate in an exercise protocol.
• Are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.

You may not qualify if…

• You are currently participating in a structured exercise program
• You have severe depression
• You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder;
• You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
• You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
• You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction

Where it is running

• Southern Methodist University — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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