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

Southern Methodist University

Status and phase: Completed; Phase 3

Conditions: Post-Traumatic Stress Disorder

Treatments: Behavioral: Prolonged Exposure; Behavioral: Wellness Intervention; Behavioral: Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT01199107

KS10-106

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 54 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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9 participants in 2 patient groups

Prolonged Exposure + Exercise

Experimental group

Treatment:

Behavioral: Exercise

Behavioral: Prolonged Exposure

Prolonged Exposure + Wellness Intervention

Active Comparator group

Treatment:

Behavioral: Wellness Intervention

Behavioral: Prolonged Exposure