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

This study is currently recruiting participants.
Verified January 2013 by Southern Methodist University
Sponsor:
Information provided by (Responsible Party):
Jasper Smits, Ph.D., Southern Methodist University
ClinicalTrials.gov Identifier:
NCT01199107
First received: September 8, 2010
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorder
 Behavioral: Prolonged Exposure
Behavioral: Exercise
Behavioral: Wellness Intervention
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Southern Methodist University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prolonged Exposure + Exercise 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
Active Comparator: Prolonged Exposure + Wellness Intervention Behavioral: Prolonged Exposure
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Behavioral: Wellness Intervention
30 minutes of wellness education prior to Prolonged Exposure

  Eligibility

Ages Eligible for Study:   18 Years to 54 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199107

Contacts
Contact: Mark B Powers, Ph.D. 214-768-7848 trauma@smu.edu

Locations
United States, Texas
Southern Methodist University Recruiting
Dallas, Texas, United States, 75206
Contact: Mark B Powers, Ph.D.     214-768-7848     trauma@smu.edu    
Sponsors and Collaborators
Southern Methodist University
  More Information

No publications provided

Responsible Party: Jasper Smits, Ph.D., Principal Investigator, Southern Methodist University
ClinicalTrials.gov Identifier: NCT01199107     History of Changes
Other Study ID Numbers: KS10-106
Study First Received: September 8, 2010
Last Updated: January 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Methodist University:
PTSD
Anxiety
Behavior Therapy
Prolonged Exposure
 Exercise
Wellness
Posttraumatic
Stress

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013