|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00847457 |
Purpose
This study will evaluate whether standardized aerobic exercise is an effective treatment for depression in adolescents.
| Condition | Intervention |
|---|---|
|
Depression |
Behavioral: Aerobic exercise Behavioral: Stretching |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Exercise Treatment for Depressed Youth |
| Estimated Enrollment: | 66 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | May 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Participants will perform aerobic exercise regularly for 12 weeks.
|
Behavioral: Aerobic exercise
Aerobic exercises completed three to four times per week for 20 to 30 minutes per session
|
|
2: Active Comparator
Participants will stretch regularly for 12 weeks.
|
Behavioral: Stretching
Easy to moderate stretching routines completed three times per week, with a new set of routines given each week
|
Major depressive disorder (MDD) is a disabling form of depression in which sadness and inability to feel pleasure prevent people from living their normal lives. MDD is common in adolescents, and depression experienced early in life can lead to long-term psychological and social impairment or suicide. Studies of depressed adults show that regular aerobic exercise can result in recovery from mild to moderate MDD. Studies also show that adolescents who exercise regularly have lower rates of depression, but no randomized, controlled studies have examined exercise as a treatment for depression in adolescents. This study will compare a standardized aerobic exercise routine to a stretching control group to determine whether aerobic exercise is an effective treatment for MDD in adolescents.
Participation in this study will last 12 weeks, with follow-up interviews taking place after 6 and 12 months. Participants will first undergo screening procedures, during which adolescent participants and their parents will complete interviews and questionnaires about the adolescent's mood and behavior. Participants will also need to provide physician-written letters confirming that they are healthy enough to participate in the exercise program. After screening, participants will be randomly assigned to either an exercise program or a stretching program. At the first study visit, a course of exercise or stretching will be set for each participant. Participants in both groups will spend the same amount of time doing physical activity. They will complete three to four exercise or stretching sessions per week for 12 weeks, with each session lasting 20 to 30 minutes. Participants will be able to complete some sessions at home, but they will need to return to the study exercise center for weekly study visits. At these study visits, participants will be weighed to determine if the level of exercise needs to be adjusted, and they will complete questionnaires about their depression. Over the course of the study, participants will wear a wrist-watch-like device called an Actical, which will monitor energy use. Participants will also undergo heart rate monitoring while exercising and complete an exercise log online. A set of questionnaires and interviews similar to those at screening will also be repeated at 6- and 12-month follow-ups.
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Carroll W. Hughes, PhD, ABPP | 214-648-4325 | carroll.hughes@utsouthwestern.edu |
| Contact: Shauna Nyquist, BA | 214-648-4681 | shauna.nyquist@utsouthwestern.edu |
| United States, Texas | |
| University of Texas Southwestern Medical Center - Dallas | Recruiting |
| Dallas, Texas, United States, 75390 | |
| Contact: Carroll W. Hughes, PhD, ABPP 214-648-4325 carroll.hughes@utsouthwestern.edu | |
| Contact: Shauna Nyquist, BA 214-648-4681 shauna.nyquist@utsouthwestern.edu | |
| Principal Investigator: Carroll W. Hughes, PhD, ABPP | |
| The Cooper Institute | Recruiting |
| Dallas, Texas, United States, 75320 | |
| Contact: Judy Dubreuil, BS 972-341-3269 jdubreuil@cooperinst.org | |
| Contact: Tyson Bain, MS 972-341-3200 tbain@cooperinst.org | |
| Principal Investigator: | Carroll W. Hughes, PhD, ABPP | University of Texas Southwestern Medical Center - Dallas |
More Information
| Responsible Party: | University of Texas Southwestern Medical Center - Dallas ( Carroll W. Hughes, PhD, ABPP, Professor of Psychiatry ) |
| Study ID Numbers: | R34 MH075762, DSIR 84-CTCT |
| Study First Received: | February 18, 2009 |
| Last Updated: | April 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00847457 History of Changes |
| Health Authority: | United States: Federal Government |
|
Exercise Stretching Adolescents |
|
Depression Mental Disorders Mood Disorders Depressive Disorder Behavioral Symptoms |