Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
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
Inclusion Criteria:

 -  Males and females ages 18-65 with a principal DSM-5 diagnosis of MDD or Persistent
 Depressive Disorder with a current Major Depressive Episode (as determined by the
 Anxiety and Related Disorders Interview Schedule-5)

 -  Sedentary (moderate-intensity exercise less than two days per week for at least 30
 minutes each time for at least 3 months)

 -  Able to provide informed consent for the study

 -  Sufficient command of the English language

 Exclusion Criteria:

 -  Current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS),
 schizophrenia or schizoaffective disorder, anorexia, bulimia, or alcohol or drug
 dependence

 -  Currently suicidal or high suicide risk (as evaluated by the Columbia Suicide Severity
 Rating Scale and BDI suicide item)

 -  Risk for exercise according to the Physical Activity Readiness Questionnaire (PAR-Q)
 in accordance with the guidelines set forth by the American College of Sports Medicine
 (ACSM) (i.e., existence of the conditions in the next bullet point)

 -  Physical conditions (e.g.,heart conditions, diabetes, asthma or another lung disease,
 bone/joint problems, or seizure disorder) interfering with the ability to exercise
 safely

 -  Individuals who have participated in cognitive behavioral therapy (CBT) directed
 towards the treatment of a mood disorder within three months of baseline, those
 simultaneously participating in another psychosocial treatment (other than supportive
 therapy) or those not currently stable (i.e., same dosage for at least 8 weeks) on
 psychotropic medications

 -  Women who are currently pregnant, plan to be pregnant in the next year, or currently
 breastfeeding