DepressionNCT00847457
Depressed Adolescents Treated With Exercise (The DATE Study)
A study testing Aerobic exercise and Stretching in people with Depression, run by University of Texas Southwestern Medical Center.
Trial summary
This study will evaluate whether standardized aerobic exercise is an effective treatment for depression in adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Aerobic exercise and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
About this study
Official title: Exercise Treatment for Depressed Youth
This study will evaluate whether standardized aerobic exercise is an effective treatment for depression in adolescents.
Read the 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
- Being tested
- Aerobic exercise, Stretching
- Keywords
- Exercise, Stretching, Adolescents
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
Aerobic exercises completed three to four times per week for 20 to 30 minutes per session
StretchingBehavioural
Easy to moderate stretching routines completed three times per week, with a new set of routines given each week
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise | Experimental | Participants will perform aerobic exercise regularly for 12 weeks. Receives: Behavioral: Aerobic exercise |
| Stretch | Active comparator | Participants will stretch regularly for 12 weeks. Receives: Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childrens Depression Rating Scale - Revised (CDRS-R)
Measured: Measured after 12 weeks, 6 months, and 12 months
Secondary outcomes (2)
Exercise feasibility and adherence
Measured: Measured after 12 weeks
Amount of energy expended, as measured by the Actical monitor
Measured: Measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Carroll Hughes, University of Texas Southwestern Medical Center
- Investigators
- Carroll W. Hughes, PhD, ABPP, Principal investigator, University of Texas Southwestern Medical Center - Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847457
- Sponsor's protocol ID
- R34MH075762
- Other IDs
- R34MH075762, DSIR 84-CTCT
- Status last verified
- Jun 2013
- First submitted
- 18 Feb 2009
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20454641
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Treatment for Depressed Youth
- ClinicalTrials.gov ID
- NCT00847457
- Acronym / sponsor ID
- R34MH075762
- Conditions
- Depression
- Keywords
- Exercise, Stretching, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jan 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise | Experimental | Behavioral: Aerobic exerciseParticipants will perform aerobic exercise regularly for 12 weeks. |
| Stretch | Active comparator | Behavioral: StretchingParticipants will stretch regularly for 12 weeks. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic exerciseAerobic exercises completed three to four times per week for 20 to 30 minutes per session | Behavioural | Aerobic exercise |
| StretchingEasy to moderate stretching routines completed three times per week, with a new set of routines given each week | Behavioural | Stretch |
Primary outcome
Childrens Depression Rating Scale - Revised (CDRS-R)
Time frame: Measured after 12 weeks, 6 months, and 12 months
2 secondary outcomes
Exercise feasibility and adherence
Time frame: Measured after 12 weeks
Amount of energy expended, as measured by the Actical monitor
Time frame: Measured after 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Background: PubMed 20454641Hughes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carroll W. Hughes, PhD, ABPP principal investigator
University of Texas Southwestern Medical Center - Dallas
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise and Stretching in people with Depression, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childrens Depression Rating Scale - Revised (CDRS-R) (time frame: Measured after 12 weeks, 6 months, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00847457, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.