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

December 8, 2014 updated by: Jasper Smits, Ph.D., Southern Methodist University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75206
        • Southern Methodist University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 54 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PTSD Symptoms
Time Frame: 3 months
Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southern Methodist University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2014

Last Update Submitted That Met QC Criteria

December 8, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS10-106

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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