Depressed Adolescents Treated With Exercise (The DATE Study)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Exercise Treatment for Depressed Youth|
- Childrens Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Measured after 12 weeks, 6 months, and 12 months ] [ Designated as safety issue: Yes ]
- Exercise feasibility and adherence [ Time Frame: Measured after 12 weeks ] [ Designated as safety issue: No ]
- Amount of energy expended, as measured by the Actical monitor [ Time Frame: Measured after 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Aerobic exercise
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
Active Comparator: Stretch
Participants will stretch regularly for 12 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847457
|Principal Investigator:||Carroll W. Hughes, PhD, ABPP||University of Texas Southwestern Medical Center - Dallas|