Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD) |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | June 2014 |
| End Date: | June 2016 |
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.
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
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
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