Depressed Adolescents Treated With Exercise (The DATE Study)

NCT ID: NCT00847457

Last Updated: 2013-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2012-04-30

Brief Summary

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

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic exercise

Participants will perform aerobic exercise regularly for 12 weeks.

Group Type: EXPERIMENTAL

Aerobic exercise

Intervention Type: BEHAVIORAL

Aerobic exercises completed three to four times per week for 20 to 30 minutes per session

Stretch

Participants will stretch regularly for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Stretching

Intervention Type: BEHAVIORAL

Easy to moderate stretching routines completed three times per week, with a new set of routines given each week

Interventions

Aerobic exercise

Aerobic exercises completed three to four times per week for 20 to 30 minutes per session

Intervention Type: BEHAVIORAL

Stretching

Easy to moderate stretching routines completed three times per week, with a new set of routines given each week

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Carroll Hughes

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carroll W. Hughes, PhD, ABPP

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center - Dallas

References

Hughes CW, Trivedi MH, Cleaver J, Greer TL, Emslie GJ, Kennard B, Dorman S, Bain T, Dubreuil J, Barnes C. DATE: Depressed adolescents treated with exercise: Study rationale and design for a pilot study. Ment Health Phys Act. 2009 Dec;2(2):76-85. doi: 10.1016/j.mhpa.2009.09.005.

Reference Type: BACKGROUND

PMID: 20454641 (View on PubMed)

Other Identifiers

R34MH075762

Identifier Type: NIH

Identifier Source: secondary_id

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DSIR 84-CTCT

Identifier Type: -

Identifier Source: secondary_id

R34MH075762

Identifier Type: NIH

Identifier Source: org_study_id

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