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

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.

Study Overview

• Status: Completed
• Conditions: Post-Traumatic Stress Disorder
• Intervention / Treatment: Behavioral: Prolonged Exposure; Behavioral: Exercise

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • The University of Texas at Austin
    • Dallas, Texas, United States, 75206
      • Southern Methodist University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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 three month protocol.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 measures that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.	3 months

Collaborators and Investigators

• Sponsor: University of Texas at Austin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: November 22, 2013
• First Submitted That Met QC Criteria: November 27, 2013
• First Posted (Estimate): November 28, 2013

Study Record Updates

• Last Update Posted (Estimate): December 29, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: PTSD; Exercise; Anxiety; Stress; Behavior Therapy; Prolonged Exposure; Wellness; Post-traumatic
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: KS10-106