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

Study Overview
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Brief Summary
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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.

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Prolonged Exposure
* Behavioral: Exercise
* Behavioral: Wellness Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 54 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged Exposure + Exercise<br> | Behavioral: Prolonged Exposure<br>* 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders<br>Behavioral: Exercise<br>* 30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure<br>|
| Active Comparator: Prolonged Exposure + Wellness Intervention<br> | Behavioral: Prolonged Exposure<br>* 75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders<br>Behavioral: Wellness Intervention<br>* 30 minutes of wellness education prior to Prolonged Exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD Symptoms | Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Quality | Sleep measure that will be assessed twice (at the beginning and end of the 3 month protocol). | 3 months | 
| BDNF (by blood sample) | Small blood sample taken twice (at the beginning and end of the 3 month protocol). | 3 months | 
| General Mood and Anxiety Symptoms | Self-report measure that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PTSD, Anxiety, Behavior Therapy, Prolonged Exposure, Exercise, Wellness, Posttraumatic, Stress