Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      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.
    

Detailed 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
    

Intervention name(s): Behavioral Activation; Exercise Intervention; Stretching Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Behavioral Activation Therapy (BA). All participants will receive a standard behavioral activation treatment based on the manualized treatment described by Lejuez et al., 2011. Treatment will be delivered in 60-minute weekly sessions over a 6-week period followed by 3 biweekly booster sessions. Behavioral activation includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.; Exercise Intervention (EX). The exercise intervention will immediately follow each of the first six weekly BA sessions. Each EX session will comprise 30 minutes of either providing rationale for the program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 40 minutes of aerobic exercise at 60-75% of maximum heart rate on three days each week, with 5 minute stretching warm up and cool down. We will help all participants initiate and plan their at-home program of exercise.; Stretching Intervention (STR). The stretching intervention will also follow each of the first six weekly BA sessions. These sessions will comprise 30 minutes of providing rationale for the stretching program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 50 minutes of stretching on three days each week. Participants in this condition will be provided with a 50-minute DVD of stretching exercises and will work with the therapist to plan their at-home stretching exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; MDD; Exercise; Physical Activity; Treatment; Behavioral Activation