Depression Outcomes Study of Exercise (DOSE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00964054
First received: August 20, 2009
Last updated: March 13, 2013
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Unipolar Depression
Other: Public Health Dose of Exercise (PHD)
Other: Low Dose Exercise (LD)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adapting Exercise Treatment for Depression to Adolescents: A Pilot Study

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Child Depression Rating Scale-Revised (CDRS-R) [ Time Frame: repeated measures, 12-weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: repeated measures, 12 weeks ] [ Designated as safety issue: Yes ]
  • The Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]
  • Adolescent Stress Questionnaire (ASQ) [ Time Frame: baseline and 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 9
Study Start Date: September 2012
Study Completion Date: February 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Public Health Dose of Exercise (PHD)
17.5 kcal per kilogram per week
Other: Public Health Dose of Exercise (PHD)
17.5 kcal per kilogram per week
Other Names:
  • Exercise
  • Physical Activity
Active Comparator: Low Dose Exercise (LD)
7.0 kcal per kilogram per week
Other: Low Dose Exercise (LD)
7.0 kcal per kilogram per week
Other Names:
  • Exercise
  • Physical Activity

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.

  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Primary Diagnosis of DSM-IV Major Depression Disorder (MDD)
  • Child Depression Rating Scale Revised > or = 40 at final screen
  • 12 to 21 years of age
  • On a stable dose of antidepressants or ADHD medication only
  • Physically capable of exercise according to AHA and ACSM standards
  • Able to pass illicit drug screen
  • Perform < 20 minutes per day of moderate to vigorous physical activity
  • Parental consent and participant assent
  • Denver metropolitan area including Jefferson county

Exclusion Criteria:

  • Chronic disease that would limit exercise
  • Other psychiatric illness
  • Suicidal or homicidal
  • Concurrent psychotherapy
  • Two previous failed SSRI trials or a failed trial of CBT
  • Current pregnancy or breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00964054

Sponsors and Collaborators
Investigators
Principal Investigator: Andrea L Dunn, PhD Klein Buendel, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00964054     History of Changes
Other Study ID Numbers: R34 MH082153, MH082153, DSIR 84-CTS
Study First Received: August 20, 2009
Last Updated: March 13, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
adolescents
exercise
depression
dose response
pilot study

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014