Depression Outcomes Study of Exercise
DOSE
Adapting Exercise Treatment for Depression to Adolescents: A Pilot Study
3 other identifiers
interventional
9
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Sep 2012
Shorter than P25 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 14, 2013
April 1, 2012
4 months
August 20, 2009
March 13, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Child Depression Rating Scale-Revised (CDRS-R)
repeated measures, 12-weeks
Secondary Outcomes (3)
Beck Depression Inventory (BDI)
repeated measures, 12 weeks
The Multidimensional Anxiety Scale for Children (MASC)
baseline and 12 weeks
Adolescent Stress Questionnaire (ASQ)
baseline and 12 weeks
Study Arms (2)
Public Health Dose of Exercise (PHD)
EXPERIMENTAL17.5 kcal per kilogram per week
Low Dose Exercise (LD)
ACTIVE COMPARATOR7.0 kcal per kilogram per week
Interventions
17.5 kcal per kilogram per week
7.0 kcal per kilogram per week
Eligibility Criteria
You may qualify if:
- Primary Diagnosis of DSM-IV Major Depression Disorder (MDD)
- Child Depression Rating Scale Revised \> or = 40 at final screen
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea L Dunn, PhD
Klein Buendel, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2009
First Posted
August 24, 2009
Study Start
September 1, 2012
Primary Completion
January 1, 2013
Study Completion
February 1, 2013
Last Updated
March 14, 2013
Record last verified: 2012-04