Depression Outcomes Study of Exercise (DOSE)
Primary Purpose
Unipolar Depression
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Public Health Dose of Exercise (PHD)
Low Dose Exercise (LD)
Sponsored by
About this trial
This is an interventional treatment trial for Unipolar Depression focused on measuring adolescents, exercise, depression, dose response, pilot study
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Public Health Dose of Exercise (PHD)
Low Dose Exercise (LD)
Arm Description
17.5 kcal per kilogram per week
7.0 kcal per kilogram per week
Outcomes
Primary Outcome Measures
Child Depression Rating Scale-Revised (CDRS-R)
Secondary Outcome Measures
Beck Depression Inventory (BDI)
The Multidimensional Anxiety Scale for Children (MASC)
Adolescent Stress Questionnaire (ASQ)
Full Information
NCT ID
NCT00964054
First Posted
August 20, 2009
Last Updated
March 13, 2013
Sponsor
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00964054
Brief Title
Depression Outcomes Study of Exercise
Acronym
DOSE
Official Title
Adapting Exercise Treatment for Depression to Adolescents: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unipolar Depression
Keywords
adolescents, exercise, depression, dose response, pilot study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Public Health Dose of Exercise (PHD)
Arm Type
Experimental
Arm Description
17.5 kcal per kilogram per week
Arm Title
Low Dose Exercise (LD)
Arm Type
Active Comparator
Arm Description
7.0 kcal per kilogram per week
Intervention Type
Other
Intervention Name(s)
Public Health Dose of Exercise (PHD)
Other Intervention Name(s)
Exercise, Physical Activity
Intervention Description
17.5 kcal per kilogram per week
Intervention Type
Other
Intervention Name(s)
Low Dose Exercise (LD)
Other Intervention Name(s)
Exercise, Physical Activity
Intervention Description
7.0 kcal per kilogram per week
Primary Outcome Measure Information:
Title
Child Depression Rating Scale-Revised (CDRS-R)
Time Frame
repeated measures, 12-weeks
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Time Frame
repeated measures, 12 weeks
Title
The Multidimensional Anxiety Scale for Children (MASC)
Time Frame
baseline and 12 weeks
Title
Adolescent Stress Questionnaire (ASQ)
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea L Dunn, PhD
Organizational Affiliation
Klein Buendel, Inc.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Depression Outcomes Study of Exercise
We'll reach out to this number within 24 hrs