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

NCT ID: NCT01199107

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post-Traumatic Stress Disorder

Keywords

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PTSD Anxiety Behavior Therapy Prolonged Exposure Exercise Wellness Posttraumatic Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Prolonged Exposure + Exercise

Group Type EXPERIMENTAL

Prolonged Exposure

Intervention Type BEHAVIORAL

75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Exercise

Intervention Type BEHAVIORAL

30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure

Prolonged Exposure + Wellness Intervention

Group Type ACTIVE_COMPARATOR

Prolonged Exposure

Intervention Type BEHAVIORAL

75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Wellness Intervention

Intervention Type BEHAVIORAL

30 minutes of wellness education prior to Prolonged Exposure

Interventions

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Prolonged Exposure

75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders

Intervention Type BEHAVIORAL

Exercise

30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure

Intervention Type BEHAVIORAL

Wellness Intervention

30 minutes of wellness education prior to Prolonged Exposure

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

54 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southern Methodist University

OTHER

Sponsor Role lead

Responsible Party

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Jasper Smits, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southern Methodist University

Dallas, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25706090 (View on PubMed)

Other Identifiers

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KS10-106

Identifier Type: -

Identifier Source: org_study_id