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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier:
NCT01199107
First received: September 8, 2010
Last updated: July 25, 2013
Last verified: July 2013

September 8, 2010
July 25, 2013
September 2010
September 2013   (final data collection date for primary outcome measure)
PTSD Symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.
Same as current
Complete list of historical versions of study NCT01199107 on ClinicalTrials.gov Archive Site
  • Sleep Quality [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Sleep measure that will be assessed twice (at the beginning and end of the 3 month protocol).
  • BDNF (by blood sample) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Small blood sample taken twice (at the beginning and end of the 3 month protocol).
  • General Mood and Anxiety Symptoms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Self-report measure that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.
Same as current
Not Provided
Not Provided
 
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
Not Provided

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Post-Traumatic Stress Disorder
  • Behavioral: Prolonged Exposure
    75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
  • Behavioral: Exercise
    30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure
  • Behavioral: Wellness Intervention
    30 minutes of wellness education prior to Prolonged Exposure
  • Experimental: Prolonged Exposure + Exercise
    Interventions:
    • Behavioral: Prolonged Exposure
    • Behavioral: Exercise
  • Active Comparator: Prolonged Exposure + Wellness Intervention
    Interventions:
    • Behavioral: Prolonged Exposure
    • Behavioral: Wellness Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 54 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01199107
KS10-106
Not Provided
Jasper Smits, Ph.D., Southern Methodist University
Southern Methodist University
Not Provided
Not Provided
Southern Methodist University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP