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

Post-Traumatic Stress Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01199107
• Other study ID #: KS10-106
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2010
• Last updated: December 8, 2014
• Start date: September 2010
• Est. completion date: August 2013

Study information

• Verified date: December 2014
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 54 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Prolonged Exposure
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
• Exercise
30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure
• Wellness Intervention
30 minutes of wellness education prior to Prolonged Exposure

Locations

Country	Name	City	State
United States	Southern Methodist University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Southern Methodist University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptoms	Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.	3 months	No
Secondary	Sleep Quality	Sleep measure that will be assessed twice (at the beginning and end of the 3 month protocol).	3 months	No
Secondary	BDNF (by blood sample)	Small blood sample taken twice (at the beginning and end of the 3 month protocol).	3 months	No
Secondary	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	No