Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression

Boston University Charles River Campus

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Behavioral: Exercise Intervention; Behavioral: Behavioral Activation; Behavioral: Stretching Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02176408

F31MH100773-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 38 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Behavioral Activation plus Exercise

Experimental group

Description:

Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)

Treatment:

Behavioral: Exercise Intervention

Behavioral: Behavioral Activation

Behavioral Activation plus Stretching

Active Comparator group

Description:

Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions)

Treatment:

Behavioral: Behavioral Activation

Behavioral: Stretching Intervention