NCT01199107

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

2.9 years

First QC Date

September 8, 2010

Last Update Submit

December 8, 2014

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSDAnxietyBehavior TherapyProlonged ExposureExerciseWellnessPosttraumaticStress

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptoms

    Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.

    3 months

Secondary Outcomes (3)

  • Sleep Quality

    3 months

  • BDNF (by blood sample)

    3 months

  • General Mood and Anxiety Symptoms

    3 months

Study Arms (2)

Prolonged Exposure + Exercise

EXPERIMENTAL
Behavioral: Prolonged ExposureBehavioral: Exercise

Prolonged Exposure + Wellness Intervention

ACTIVE COMPARATOR
Behavioral: Prolonged ExposureBehavioral: Wellness Intervention

Interventions

Prolonged ExposureBEHAVIORAL

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

Prolonged Exposure + ExerciseProlonged Exposure + Wellness Intervention
ExerciseBEHAVIORAL

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

Prolonged Exposure + Exercise
Wellness InterventionBEHAVIORAL

30 minutes of wellness education prior to Prolonged Exposure

Prolonged Exposure + Wellness Intervention

Eligibility Criteria

Age18 Years - 54 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Methodist University

Dallas, Texas, 75206, United States

Location

Related 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: 10.1080/16506073.2015.1012740. Epub 2015 Feb 23.

    PMID: 25706090DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAnxiety DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2010

First Posted

September 10, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations

US(1)