DepressionCARENCT05837351
The CARE (Collaborative Adolescent Running Experience) Project
A study testing Exercise -Running in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
Trial summary
This study is being completed to see if participants activity levels may have an impact as a treatment for depression, or depressive symptoms. Eligible participants will be enrolled and have an 8-week running intervention three times each week. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Depression, Anxiety, Major Depressive Disorder
- What is being tested?
- Exercise -Running
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2023to 30 Apr 2024
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Psychiatric disorders that are experiencing depressive symptoms (defined by the protocol)
- Must have a smart phone
- Parents/guardians will be advised to discuss their child's participation in the intervention with the participant's primary care physician
Who cannot join
- Adolescents with unstable cardiac, pulmonary, endocrine or renal disorders
- Adolescents with previous injuries or other conditions that may impact the safety of a running intervention
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The CARE Project: Collaborative Adolescent Running Experience
This study is being completed to see if participants activity levels may have an impact as a treatment for depression, or depressive symptoms.
Eligible participants will be enrolled and have an 8-week running intervention three times each week.
The study hypothesizes that adolescents with Psychiatric disorders that are experiencing depressive symptoms will participate in a supported running intervention.
- Conditions
- Depression, Anxiety, Major Depressive Disorder, Bipolar Disorder
- Being tested
- Exercise -Running
- Keywords
- Running, Adolescents
- Medical subject headings
- Depression, Anxiety Disorders, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise -RunningBehavioural
At baseline participants will wear a Fitbit for one week and attend the Runner's Assessment. After this the participant will begin to run 3 times per week for eight weeks. Every week, participation in a virtual support group with the physical therapist, research coordinator, and other research staff will be expected. Rest-activity cycles' data will be monitored; if at any point the runner is not able to complete 3 runs per week, participants will be encouraged to contact research staff the issues for this (such as medical problem or scheduling difficulty) and formulate plans to remediate the situation. Participants that would like to continue the treatment for an additional eight weeks will have additional data collected.
Participants will also wear the Fitbit through-out the study and complete surveys during the study and have blood drawn.
| Study group | Role | What they receive |
|---|---|---|
| Exercise -Running | Experimental | Not described Receives: Behavioral: Exercise -Running |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of completed running sessions
Feasibility and acceptability of the study will be the completion of running sessions based on the Fitbit and or self-report.
Measured: weeks 1-8 during treatment period
Secondary outcomes (1)
Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)
This is a self-report questionnaire designed for the purpose of assessing anxiety, mood, eating, and substance use disorders. For the first section (9 questions) the participants will select from Not at all (0) to nearly every day (3).
The next section asks if in the past year participants felt depressed or sad most days (yes or no) and if so, not difficult at all to extremely difficult. The last question participants are asked about suicide. Scores of 5, 10, 15, and 20 represent cut points for mild, moderate, moderately severe and severe depression.
Measured: Baseline (prior to treatment), 8 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start5 Dec 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Dopp, University of Michigan
- Investigators
- Richard Dopp, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05837351
- Sponsor's protocol ID
- HUM00212052
- Acronym
- CARE
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CARE Project: Collaborative Adolescent Running Experience
- ClinicalTrials.gov ID
- NCT05837351
- Acronym / sponsor ID
- CARE / HUM00212052
- Conditions
- Depression, Anxiety, Major Depressive Disorder, Bipolar Disorder
- Keywords
- Running, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 May 2023 (actual)
- 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 is being completed to see if participants activity levels may have an impact as a treatment for depression, or depressive symptoms.
Eligible participants will be enrolled and have an 8-week running intervention three times each week.
The study hypothesizes that adolescents with Psychiatric disorders that are experiencing depressive symptoms will participate in a supported running intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise -Running | Experimental | Behavioral: Exercise -Running |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Psychiatric disorders that are experiencing depressive symptoms (defined by the protocol)
- Must have a smart phone
- Parents/guardians will be advised to discuss their child's participation in the intervention with the participant's primary care physician
Key exclusion criteria (2 listed)
- Adolescents with unstable cardiac, pulmonary, endocrine or renal disorders
- Adolescents with previous injuries or other conditions that may impact the safety of a running intervention
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 |
|---|---|---|
| Exercise -RunningAt baseline participants will wear a Fitbit for one week and attend the Runner's Assessment. After this the participant will begin to run 3 times per week for eight weeks. Every week, participation in a virtual support group with the physical therapist, research coordinator, and other research staff will be expected. Rest-activity cycles' data will be monitored; if at any point the runner is not able to complete 3 runs per week, participants will be encouraged to contact research staff the issues for this (such as medical problem or scheduling difficulty) and formulate plans to remediate the situation. Participants that would like to continue the treatment for an additional eight weeks will have additional data collected. Participants will also wear the Fitbit through-out the study and complete surveys during the study and have blood drawn. | Behavioural | Exercise -Running |
Primary outcome
The number of completed running sessions
Time frame: weeks 1-8 during treatment period
Feasibility and acceptability of the study will be the completion of running sessions based on the Fitbit and or self-report.
1 secondary outcome
Change in depression severity as reported by The Patient Health Questionnaire for Adolescents (PHQ-A)
Time frame: Baseline (prior to treatment), 8 weeks (post intervention)
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 13 Jun 2024.
- Individual participant dataSharing planned: No
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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.
Richard Dopp, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise -Running in people with Depression and Anxiety, run by University of Michigan at 1 site in United States.
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 3 inclusion and 2 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 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The number of completed running sessions (time frame: weeks 1-8 during treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2024.