Depression Outcomes Study of Exercise
Condition: Unipolar Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study may yield important research findings on how to adapt exercise treatment for
      depression among adolescents. Potential public health benefits from this study include a
      reduction of adolescent depression and problems associated with untreated depression in young
      adults including suicide, substance abuse, cigarette smoking, teen pregnancy, impaired
      psychosocial functioning and school failure. In addition, because this study prescribes
      physical activity as a treatment for depression, additional public health benefits may
      include a reduction in chronic diseases such as obesity, diabetes and heart disease, all of
      which are associated with sedentary behavior.
    

Detailed description: 
      Adolescent depression is a major public health problem in the United States and throughout
      the world. Major depressive disorder (MDD) in adolescence is common with point prevalence
      rates of 3% to 9%. In the U.S., it is estimated that by the time adolescents reach the age of
      17, 14% will have experienced at least one episode of major depressive disorder. Effective
      treatments of adolescent depression are clearly needed despite the fact that in the past
      10-15 years, there has been a dramatic increase in studies of the efficacy of medications,
      primarily the selective serotonin reuptake inhibitors (SSRIs) and of cognitive behavioral
      therapy (CBT). Medications and CBT rarely result in complete and lasting remission of
      symptoms, and residual symptoms are associated with a high rate of relapse. In most studies,
      a positive response is defined as a 30-50% improvement in symptoms and/or a global rating
      that the subject is much or very much improved. In adults, exercise has been used as a
      mono-therapy and as an augmentation therapy with antidepressant medication. Our recently
      completed randomized trial of exercise treatment in adults found response and remission rates
      of 46% and 42%, in those randomized to a public health dose of exercise. In adolescents, data
      on the use of exercise to treat MDD is relatively sparse. A 2006 Cochrane review of exercise
      to prevent and treat depression in adolescents found a small effect size in support of
      exercise, but the conclusion is based on evidence from a small number of randomized clinical
      trials of low methodological quality. In this exploratory R34, the specific aims of this
      application are to: 1) Develop a detailed Manual of Procedures (MOP) to conduct an
      acute-phase randomized trial of exercise to treat adolescent depression; 2) Develop estimates
      of recruitment yield from tests of various recruitment strategies; and, 3) Pilot test trial
      methodologies in (n=40) adolescents diagnosed with depression to ascertain estimates of
      treatment effect sizes, adherence and drop-out rates. To achieve these aims, the project is
      organized into 3 phases. Phase I will be the development of the first draft MOP that will
      adapt procedures developed from a previous trial examining two doses of exercise in treatment
      of adult MDD. Phase II will test specific recruitment methodologies to determine recruitment
      yields for each strategy and will pilot test screening procedures developed in Phase I. Phase
      III will be a pilot test of the intervention and will include development of baseline and
      outcome measures of exercise and depression; development and implementation of the
      experimental exercise treatment; and determination of the effects of exercise on depressive
      symptoms. Following the pilot study, we will finalize all procedures for the MOP and obtain
      estimates of effect sizes, adherence and drop out rates. These data will allow us to specify
      all study procedures necessary to meet standards of high methodological quality for a future,
      larger-scale, controlled study of exercise in depressed youth and will provide us with needed
      experience.
    

Intervention name(s): Public Health Dose of Exercise (PHD); Low Dose Exercise (LD)
Intervention type(s): Other; Other
Intervention description(s): 17.5 kcal per kilogram per week; 7.0 kcal per kilogram per week
Other intervention name(s): Exercise; Physical Activity; Exercise; Physical Activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescents; exercise; depression; dose response; pilot study