Major Depressive Disorder Clinical Trial
Official title:
Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Major depressive disorder (MDD) is the leading cause of disability in the developed world and is associated with lost productivity, increased health care utilization, and mortality. Several empirically supported treatments, such as antidepressant medication and cognitive behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many as 34% of individuals do not respond to these treatments. Exercise and stretching interventions represent alternative strategies associated with strong effect sizes in past studies. Additionally, exercise has been shown to enhance cognitive functioning, especially attention and memory. This study aims to investigate the effect of a combined aerobic exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment involves completing both pleasant and mastery-based activities with the goal of enhancing mood. The current study will recruit 32 MDD patients for an active treatment phase of nine 60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an active control condition.
Individuals with major depressive disorder (MDD) will be recruited to participate in a free
treatment trial of a combined exercise or stretching regimen plus behavioral activation
treatment. All individuals will receive 6 weekly and 3 biweekly 1-hour sessions of behavioral
activation treatment. Behavioral activation involves exploring values in different life areas
(relationships, education/career, interests, etc.) and scheduling activities in line with
these values. Research has shown that behavioral activation treatment can improve mood and
alleviate depressive symptoms.
In addition, participants will be randomized (like a flip of a coin) to either an additional
aerobic exercise intervention or an additional stretching intervention. These interventions
will take place for half an hour after the first 6 weeks of the behavioral activation
intervention. The purpose of this study is to examine if adding an aerobic exercise
intervention to a brief psychosocial treatment can improve mood above and beyond an active
control condition.
Throughout the study, participants will complete computer, questionnaire, and interview
assessments as well as exercise tests and a blood draw. The details of each visit are listed
below. For full completion of this study, participants can earn up to $100.
Screening visit: diagnostic interview, assessment for physical activity risk (brief meeting
with physician)
Baseline visit (week 0): submaximal exercise test, blood draw, questionnaire measures,
computer tests
Treatment visit 1 (week 1): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 2 (week 2): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 3 (week 3): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 4 (week 4): BA treatment + EX/STR intervention, questionnaires, submaximal
exercise test, blood draw
Treatment visit 5 (week 5): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 6 (week 6): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 7 (week 8): BA treatment, questionnaires, submaximal exercise test, blood
draw
Treatment visit 8 (week 10): BA treatment, brief questionnaires
Treatment visit 9 (week 12): BA treatment, questionnaire measures
Final assessment (week 16): submaximal exercise test, blood draw, questionnaire measures,
computer tests
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