The Effects of Exercise on Depression Symptoms Using Levels of Neurotransmitters and EEG as Markers
1 other identifier
interventional
11
1 country
2
Brief Summary
The purpose of this study is to examine the effects of exercise on the symptoms of depression using serum levels of serotonin, catecholamine's, Alpha EEG asymmetry, and self-report of symptoms as markers. In an attempt to further understand the mechanisms of improved mood through exercise; this study will examine the known factors that contribute to depressed mood in a single study using serotonin and catecholamine levels via blood serum and EEG slow wave asymmetry. Such information can be useful in understanding the overall neurological components of depression and the effects of exercise on the brain in depressed individuals that would make the prescription of exercise a viable treatment option.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Mar 2013
Shorter than P25 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 23, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedDecember 30, 2013
December 1, 2013
2 months
December 23, 2013
December 23, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Scores on the Beck Depression Inventory-II
The BDI-II is a 21 item self-report screening tool that measures symptoms of depression.
Pre and post intervention over the 3 month span of the study
Secondary Outcomes (1)
Serum levels of serotonin and catecholomine
Pre and post intervention over the 3 month span of the study
Other Outcomes (1)
Mean EEG alpha frequency data in the pre-frontal cortex.
Pre and post intervention over the 3 month span of the study.
Study Arms (2)
Control Group
NO INTERVENTIONControl group will serve as a wait list and not be exposed to the intervention.
Experimental Group
EXPERIMENTALThe experimental group will engage in a mild-moderate level of structured and clinically supervised exercise program for approx. 30-45 mins 2-3 days per week for 12 weeks
Interventions
The experimental group will engage in mild-moderate level of exercise. This program will be structured and clinically supervised. Exercise will take place 2-3 days per week for a duration of 30-45 mins. for 12 weeks.
Eligibility Criteria
You may qualify if:
- primary diagnosis of depression
- years of age
- Physically fit to engage in physical exercise
You may not qualify if:
- Participants with a history or current symptoms of psychosis
- anticipation of psychiatric medication changes over the course of the study
- Bipolar disorder or other disorder reflecting reality testing impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liberty Universitylead
- CommonSpirit Healthcollaborator
Study Sites (2)
Liberty University
Lynchburg, Virginia, 24502, United States
Centra Health; Health Works
Lynchburg, Virginia, 24503, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy H Barclay, Ph.D.
Liberty University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor; Licensed Clinical Psychologist
Study Record Dates
First Submitted
December 23, 2013
First Posted
December 30, 2013
Study Start
March 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
December 30, 2013
Record last verified: 2013-12