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Depressed Adolescents Treated With Exercise (The DATE Study)
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), April 2009
First Received: February 18, 2009   Last Updated: April 3, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Childrens Depression Rating Scale - Revised (CDRS-R) [ Time Frame: Measured after 12 weeks, 6 months, and 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

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

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry
  • Clinical Global Impression-Severity (CGI-S) score of 4 or greater
  • Children's Depression Rating Scale (CDRS) score of greater than 35 but less than 71
  • Currently attending school
  • Willing and able to use acceptable methods of contraception, if applicable
  • A signed letter from family physician verifying physical health necessary for participation in the exercise program
  • Response to the Physical Activity Readiness Questionnaire (PAR-Q) indicates that no conditions are present that would render exercise inappropriate
  • Speaks and reads English
  • Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

  • Currently on an antidepressant medication
  • Severe suicidal ideation
  • History of psychotic disorders
  • Alcohol or substance abuse or dependence within 6 months of study entry
  • History of anorexia nervosa or bulimia
  • Chronic medical illness requiring regular medication
  • Pregnant
  • Currently participating in a vigorous exercise program or activity, defined as 30 minutes of vigorous physical activity five times per week
  • IQ less than 70
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847457

Contacts
Contact: Carroll W. Hughes, PhD, ABPP 214-648-4325 carroll.hughes@utsouthwestern.edu
Contact: Shauna Nyquist, BA 214-648-4681 shauna.nyquist@utsouthwestern.edu

Locations
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    
Sponsors and Collaborators
Investigators
Principal Investigator: Carroll W. Hughes, PhD, ABPP University of Texas Southwestern Medical Center - Dallas
  More Information

No publications provided

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

Keywords provided by National Institute of Mental Health (NIMH):
Exercise
Stretching
Adolescents

Additional relevant MeSH terms:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on November 27, 2009