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

Phase 3

Completed

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

• Registration Number: NCT01998100
• Lead Sponsor: University of Texas at Austin

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Study First Submitted: 2013-11-22
• Study First Submitted QC: 2013-11-27
• Study First Posted: 2013-11-28
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-28
• Last Update Posted: 2015-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

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 three month protocol.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

The University of Texas at Austin; 🇺🇸 Austin, Texas, United States

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