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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01199107
Enrollment
9
Registered
2010-09-10
Start date
2010-09-30
Completion date
2013-08-31
Last updated
2014-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD, Anxiety, Behavior Therapy, Prolonged Exposure, Exercise, Wellness, Posttraumatic, Stress

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.

Interventions

30 minutes of wellness education prior to Prolonged Exposure

BEHAVIORALProlonged Exposure

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

BEHAVIORALExercise

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

Sponsors

Southern Methodist University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PTSD Symptoms3 monthsSelf-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.

Secondary

MeasureTime frameDescription
Sleep Quality3 monthsSleep measure that will be assessed twice (at the beginning and end of the 3 month protocol).
BDNF (by blood sample)3 monthsSmall blood sample taken twice (at the beginning and end of the 3 month protocol).
General Mood and Anxiety Symptoms3 monthsSelf-report measure that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026