Depressed Adolescents Treated With Exercise (The DATE Study)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carroll Hughes, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00847457
First received: February 18, 2009
Last updated: June 26, 2013
Last verified: June 2013
  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: 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

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 ]

Enrollment: 40
Study Start Date: January 2009
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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:

  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847457

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

Publications:
Responsible Party: Carroll Hughes, Principal Investigator, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00847457     History of Changes
Other Study ID Numbers: R34 MH075762, R34MH075762, DSIR 84-CTCT
Study First Received: February 18, 2009
Last Updated: June 26, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Texas Southwestern Medical Center:
Exercise
Stretching
Adolescents

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 19, 2014