Depressed Adolescents Treated With Exercise (The DATE Study)

June 26, 2013 updated by: Carroll Hughes, University of Texas Southwestern Medical Center

Exercise Treatment for Depressed Youth

This study will evaluate whether standardized aerobic exercise is an effective treatment for depression in adolescents.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Childrens Depression Rating Scale - Revised (CDRS-R)
Time Frame: Measured after 12 weeks, 6 months, and 12 months
Measured after 12 weeks, 6 months, and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise feasibility and adherence
Time Frame: Measured after 12 weeks
Measured after 12 weeks
Amount of energy expended, as measured by the Actical monitor
Time Frame: Measured after 12 weeks
Measured after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Carroll W. Hughes, PhD, ABPP, University of Texas Southwestern Medical Center - Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2009

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

February 18, 2009

First Posted (Estimate)

February 19, 2009

Study Record Updates

Last Update Posted (Estimate)

June 27, 2013

Last Update Submitted That Met QC Criteria

June 26, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R34MH075762 (U.S. NIH Grant/Contract)
  • DSIR 84-CTCT

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.

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