Maximizing Treatment Outcome in Post-Traumatic Stress Disorder (PTSD)

Post-Traumatic Stress Disorder Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998100
• Other study ID #: KS10-106
• Status: Completed
• Phase: Phase 3
• First received: November 22, 2013
• Last updated: December 28, 2015
• Start date: September 2010
• Est. completion date: July 2013

Study information

• Verified date: December 2015
• Source: University of Texas at Austin
• 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 + therapy to therapy alone 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 + therapy and therapy alone condition) will be compared in terms of levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth of 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 symptoms PTSD improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• You have PTSD.

• You are between the ages of 18 and 65.

• You have written physician approval/medical clearance to participate in an exercise protocol.

• You 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 a significant risk or 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

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas
United States	Southern Methodist University	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

References & Publications (1)

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: 10.1080/16506073.2015.101 — View Citation

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 three 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 measures that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.	3 months	No