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

Phase 3

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: Prolonged Exposure; Behavioral: Exercise; Behavioral: Wellness Intervention

• Registration Number: NCT01199107
• Lead Sponsor: Southern Methodist University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-09-09
• Study First Posted: 2010-09-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prolonged Exposure + Exercise	Exercise	-
Prolonged Exposure + Exercise	Prolonged Exposure	-
Prolonged Exposure + Wellness Intervention	Prolonged Exposure	-
Prolonged Exposure + Wellness Intervention	Wellness Intervention	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Southern Methodist University; 🇺🇸 Dallas, Texas, United States