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Completed

NCT Number: NCT01199107

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

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.

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Key information

Conditions

Post-traumatic Stress Disorder Anxiety Disorders Behavior Mental Disorders Motor Activity Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–54 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southern Methodist University

Dallas, Texas, 75206, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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

Treatment and study plan

Prolonged Exposure

Behavioral

75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Exercise

Behavioral

30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure

Wellness Intervention

Behavioral

30 minutes of wellness education prior to Prolonged Exposure

Primary outcomes

  1. PTSD Symptoms

    Time frame: 3 months

    Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.

Secondary outcomes

  1. Sleep Quality

    Time frame: 3 months

    Sleep measure that will be assessed twice (at the beginning and end of the 3 month protocol).

  2. BDNF (by blood sample)

    Time frame: 3 months

    Small blood sample taken twice (at the beginning and end of the 3 month protocol).

  3. General Mood and Anxiety Symptoms

    Time frame: 3 months

    Self-report measure that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.

Sponsors and collaborators

Lead sponsor

Southern Methodist University

Other

Registry information

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2010
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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