Depression Outcomes Study of Exercise (DOSE)
March 13, 2013 updated by: National Institute of Mental Health (NIMH)
Adapting Exercise Treatment for Depression to Adolescents: A Pilot Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 21 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Public Health Dose of Exercise (PHD)
17.5 kcal per kilogram per week
|
17.5 kcal per kilogram per week
Other Names:
|
|
Active Comparator: Low Dose Exercise (LD)
7.0 kcal per kilogram per week
|
7.0 kcal per kilogram per week
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Child Depression Rating Scale-Revised (CDRS-R)
Time Frame: repeated measures, 12-weeks
|
repeated measures, 12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Beck Depression Inventory (BDI)
Time Frame: repeated measures, 12 weeks
|
repeated measures, 12 weeks
|
|
The Multidimensional Anxiety Scale for Children (MASC)
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
|
Adolescent Stress Questionnaire (ASQ)
Time Frame: baseline and 12 weeks
|
baseline and 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrea L Dunn, PhD, Klein Buendel, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
August 20, 2009
First Submitted That Met QC Criteria
August 20, 2009
First Posted (Estimate)
August 24, 2009
Study Record Updates
Last Update Posted (Estimate)
March 14, 2013
Last Update Submitted That Met QC Criteria
March 13, 2013
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R34MH082153 (U.S. NIH Grant/Contract)
- DSIR 84-CTS (Division of Services and Intervention Research)
- MH082153
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.