Major Depressive Disorder Clinical Trial
Official title:
Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Verified date | August 2019 |
Source | Boston University Charles River Campus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston University Charles River Campus | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Montgomery-Asberg Depression Rating Scale (MADRS) | The MADRS is a 10-item clinician-rated measure of correlates of depression. Specifically, this questionnaire measures the following: sadness, tension, sleep, appetite, concentration, lassitude, numbness, pessimism, and suicidal ideation. The scale ranges from 0-60 with higher totals indicating worse depression. The following are norms for severity: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; and >34 - severe depression. | Week 16 | |
Secondary | Beck Depression Inventory-II (BDI-II) | The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms. Scores range from 0-63 with higher scores indicating worse depression. The following are severity norms for the measure: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. | Week 16 | |
Secondary | Work and Social Adjustment Scale (WSAS) | The WSAS is a self-report scale of functional impairment attributable to an identified problem, in this case MDD. Scores range from 0 to 40 with higher scores indicating worse functioning. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinicalsymptomatology. Scores below 10 appear to be associated with subclinical populations. | Week 16 | |
Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | The Q-LES-Q rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Scores range from 14 to 70 with lower scores indicating worse quality of life. | Week 16 | |
Secondary | Logical Memory | Participants will be read a story and asked to remember as many details as possible. Raw scores are reported with a range in the current sample from from 17 to 47 with higher scores indicating better memory performance. | Week 16 | |
Secondary | Continuous Performance Test- Identical Pairs | Participants' attention will be assessed using the CPT which is a choice reaction time task which requires a subject to respond whenever two identical stimuli appear in a row within a sequence of rapidly flashed trials. Scores represent the average d' across 2 digit, 3 digit, and 4 digit trials. Average scores in this sample ranged from 1.76 to 4.24. Lower d' represents a better score. | Week 16 | |
Secondary | 7 Day Physical Activity Recall (PAR) | The PAR is is an interviewer-administered measure of physical activity behavior that will be used as a self-report validation measure of amount of physical activity completed. Metabolic equivalents (METs) of moderate and vigorous intensity activity are reported. METs of activity ranged from 0 to 1520 in this sample with higher numbers indicating more physical activity completed. | Week 16 | |
Secondary | Brain-derived Neurotrophic Factor (BDNF) | Blood samples (approximately 1 tsp) will be collected at baseline, week 4, week 8, and week 16 to test serum BDNF. Changes in resting BDNF levels were assessed. BDNF levels ranged from 14391 to 43020 ng/ml in this sample with higher levels indicating more BDNF. | Week 16 |
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