Back to resultsMaximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
Primary Purpose
Post-Traumatic Stress Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure
Exercise
Wellness Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring PTSD, Anxiety, Behavior Therapy, Prolonged Exposure, Exercise, Wellness, Posttraumatic, Stress
Eligibility 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
Sites / Locations
- Southern Methodist University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prolonged Exposure + Exercise
Prolonged Exposure + Wellness Intervention
Arm Description
Outcomes
Primary Outcome Measures
PTSD Symptoms
Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.
Secondary Outcome Measures
Sleep Quality
Sleep measure that will be assessed twice (at the beginning and end of the 3 month protocol).
BDNF (by blood sample)
Small blood sample taken twice (at the beginning and end of the 3 month protocol).
General Mood and Anxiety Symptoms
Self-report measure that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.
Full Information
NCT ID
NCT01199107
First Posted
September 8, 2010
Last Updated
December 8, 2014
Sponsor
Southern Methodist University
1. Study Identification
Unique Protocol Identification Number
NCT01199107
Brief Title
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southern Methodist University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder
Keywords
PTSD, Anxiety, Behavior Therapy, Prolonged Exposure, Exercise, Wellness, Posttraumatic, Stress
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prolonged Exposure + Exercise
Arm Type
Experimental
Arm Title
Prolonged Exposure + Wellness Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure
Intervention Description
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure
Intervention Type
Behavioral
Intervention Name(s)
Wellness Intervention
Intervention Description
30 minutes of wellness education prior to Prolonged Exposure
Primary Outcome Measure Information:
Title
PTSD Symptoms
Description
Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sleep Quality
Description
Sleep measure that will be assessed twice (at the beginning and end of the 3 month protocol).
Time Frame
3 months
Title
BDNF (by blood sample)
Description
Small blood sample taken twice (at the beginning and end of the 3 month protocol).
Time Frame
3 months
Title
General Mood and Anxiety Symptoms
Description
Self-report measure that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Southern Methodist University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75206
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25706090
Citation
Powers MB, Medina JL, Burns S, Kauffman BY, Monfils M, Asmundson GJ, Diamond A, McIntyre C, Smits JA. Exercise Augmentation of Exposure Therapy for PTSD: Rationale and Pilot Efficacy Data. Cogn Behav Ther. 2015;44(4):314-27. doi: 10.1080/16506073.2015.1012740. Epub 2015 Feb 23.
Results Reference
derived
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Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
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