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Clinical Trials/NCT01998100
NCT01998100
Completed
Phase 3

Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)

University of Texas at Austin2 sites in 1 country28 target enrollmentSeptember 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorder
Sponsor
University of Texas at Austin
Enrollment
28
Locations
2
Primary Endpoint
PTSD Symptoms
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to examine the efficacy of exercise + therapy to therapy alone 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 + therapy and therapy alone condition) will be compared in terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth of 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 symptoms PTSD improvement.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
July 2013
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark B. Powers

Research Associate Professor

University of Texas at Austin

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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 a significant risk or self-harm or harm to others.
  • You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction.

Outcomes

Primary Outcomes

PTSD Symptoms

Time Frame: 3 months

Self-report measure that assesses PTSD symptoms. Will be assessed at each visit throughout the three month protocol.

Secondary Outcomes

  • General Mood and Anxiety Symptoms(3 months)
  • BDNF (by blood sample)(3 months)

Study Sites (2)

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