Depressive SymptomsHFEDANCT06677723
High- vs Low-Frequency Exercise for Depression in Adolescents
A study testing physical activity in people with Depressive Symptoms, run by Je Bouge Pour Mon Moral at 1 site in France.
Trial summary
This research project aims to examine the antidepressant effects of different exercise routines on adolescent depression, which has risen significantly in recent years. Depression, particularly prevalent among adolescents at a global rate of around 12%, is associated with reduced positive emotional responses and… Read more about this study
- Who is it for?
- Ages 18 to 22 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFrance
- Study dates
- 11 Mar 2024to 20 May 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 18 to 22 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- baseline PHQ-9 score > 9 (i.e., "moderate depression")
Who cannot join
- unability to read and understand French language
- specific medical contraindications for physical activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Differential Effects of High-frequency Versus Low-frequency Exercise Training in Adolescents With Elevated Depressive Symptoms.
This research project aims to examine the antidepressant effects of different exercise routines on adolescent depression, which has risen significantly in recent years. Depression, particularly prevalent among adolescents at a global rate of around 12%, is associated with reduced positive emotional responses and difficulties in managing negative emotions. Prior studies indicate that physical activity can boost positive moods, like feelings of excitement and calm, potentially leading to overall mood stabilization with regular exercise. However, results on how exercise influences negative moods remain inconsistent. This study will compare two exercise routines-a single 60-minute weekly session versus four 15-minute weekly sessions of moderate-intensity running-over three weeks to determine which approach has a stronger effect on reducing depressive symptoms in adolescents.
Read the detailed description
Depression is a mental disorder that affects millions of people globally every year. This mental health issue is particularly prominent in adolescents populations, where depression has been found to increase at a greater rate than in adults over the last decade. In concrete terms, the global current prevalence of depressive disorders (major depressive disorder and dysthymia) is about 7-8% in adults worldwide, whereas it is around 12% among adolescents.
Depression is characterized by a limited capacity to inhibit negative emotions and a dampening of positive affective and emotional reactions.
There is strong evidence that physical activity increases pleasant-activated states like excitement and vigor both immediately following a bout of exercise and more accumulatively, and some studies show that physical activity enhances pleasant-deactivated affective states like calmness or relaxation. Over time, these acute affective responses to physical activity may accumulate to chronically regulate core affect. One logical implication of all this is that shorter but more frequent exercise sessions throughout the week will offer repeated doses of mood improvement, leading to a more stable mood over time, which should predict greater reductions in depressive symptoms.
Previous studies have reported inconsistent and inconclusive findings for the influence of physical activity on unpleasant core affects, and the general pattern in previous research is that physical activity has a more pronounced effect on positive affect than negative affect. Although, recent findings suggest that daily moderate to vigorous physical activity can decrease the level of depressed and angry affects in adolescents.
Therefore, the current randomized controlled study aims to compare the antidepressant effects of a 3-week exercise program with either one weekly 60-minute session or four weekly 15-minute sessions of moderate-intensity running among adolescents (in which findings have been mixed to date).
- Conditions
- Depressive Symptoms
- Being tested
- physical activity
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activityBehavioural
moderate-intensity running
| Study group | Role | What they receive |
|---|---|---|
| RUN_1*60 | Experimental | exercise training including one weekly running session (60-min long) for 3 weeks Receives: Behavioral: physical activity |
| RUN_4*15 | Experimental | exercise training including 4 weekly running sessions (15-min long) for 3 weeks Receives: Behavioral: physical activity |
| CONTROL | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in depressive symptoms
Depression scores will be obtained using the self-report instrument "Patient Health Questionnaire-9" (PHQ-9). This self-report measure has 9 items that assess depressive symptoms. Items are rated on a 4-point scale ranging from 0 to 3. The final score is obtained by adding the score of each item and can range from 0 to 27 with higher scores indicating greater severity of depressive symptoms. A score of 0-4 indicates no depression, scores 5-9 indicate mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20 or above indicates severe depression.
Measured: PHQ-9 completed the day before and the day after the 3-week long exercise program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start11 Mar 2024
- Primary completion13 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Je Bouge Pour Mon Moral
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabien Legrand, Je Bouge Pour Mon Moral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677723
- Sponsor's protocol ID
- Depression_adolescent_1st_step
- Acronym
- HFEDA
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: anonymized full set of raw data (PHQ-9 scores before and after participation) will be made available
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Effects of High-frequency Versus Low-frequency Exercise Training in Adolescents With Elevated Depressive Symptoms.
- ClinicalTrials.gov ID
- NCT06677723
- Acronym / sponsor ID
- HFEDA / Depression_adolescent_1st_step
- Conditions
- Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Je Bouge Pour Mon MoralUniversity, hospital or other
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 7 Nov 2024 (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 research project aims to examine the antidepressant effects of different exercise routines on adolescent depression, which has risen significantly in recent years. Depression, particularly prevalent among adolescents at a global rate of around 12%, is associated with reduced positive emotional responses and difficulties in managing negative emotions. Prior studies indicate that physical activity can boost positive moods, like feelings of excitement and calm, potentially leading to overall mood stabilization with regular exercise. However, results on how exercise influences negative moods remain inconsistent. This study will compare two exercise routines-a single 60-minute weekly session versus four 15-minute weekly sessions of moderate-intensity running-over three weeks to determine which approach has a stronger effect on reducing depressive symptoms in adolescents.
Detailed description
Depression is a mental disorder that affects millions of people globally every year. This mental health issue is particularly prominent in adolescents populations, where depression has been found to increase at a greater rate than in adults over the last decade. In concrete terms, the global current prevalence of depressive disorders (major depressive disorder and dysthymia) is about 7-8% in adults worldwide, whereas it is around 12% among adolescents.
Depression is characterized by a limited capacity to inhibit negative emotions and a dampening of positive affective and emotional reactions.
There is strong evidence that physical activity increases pleasant-activated states like excitement and vigor both immediately following a bout of exercise and more accumulatively, and some studies show that physical activity enhances pleasant-deactivated affective states like calmness or relaxation. Over time, these acute affective responses to physical activity may accumulate to chronically regulate core affect. One logical implication of all this is that shorter but more frequent exercise sessions throughout the week will offer repeated doses of mood improvement, leading to a more stable mood over time, which should predict greater reductions in depressive symptoms.
Previous studies have reported inconsistent and inconclusive findings for the influence of physical activity on unpleasant core affects, and the general pattern in previous research is that physical activity has a more pronounced effect on positive affect than negative affect. Although, recent findings suggest that daily moderate to vigorous physical activity can decrease the level of depressed and angry affects in adolescents.
Therefore, the current randomized controlled study aims to compare the antidepressant effects of a 3-week exercise program with either one weekly 60-minute session or four weekly 15-minute sessions of moderate-intensity running among adolescents (in which findings have been mixed to date).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RUN_1*60 | Experimental | Behavioral: physical activityexercise training including one weekly running session (60-min long) for 3 weeks |
| RUN_4*15 | Experimental | Behavioral: physical activityexercise training including 4 weekly running sessions (15-min long) for 3 weeks |
| CONTROL | No intervention | –control group |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- baseline PHQ-9 score > 9 (i.e., "moderate depression")
Key exclusion criteria (2 listed)
- unability to read and understand French language
- specific medical contraindications for physical activity
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 |
|---|---|---|
| physical activitymoderate-intensity running | Behavioural | RUN_1*60, RUN_4*15 |
Primary outcome
changes in depressive symptoms
Time frame: PHQ-9 completed the day before and the day after the 3-week long exercise program
Depression scores will be obtained using the self-report instrument "Patient Health Questionnaire-9" (PHQ-9). This self-report measure has 9 items that assess depressive symptoms. Items are rated on a 4-point scale ranging from 0 to 3. The final score is obtained by adding the score of each item and can range from 0 to 27 with higher scores indicating greater severity of depressive symptoms. A score of 0-4 indicates no depression, scores 5-9 indicate mild depression, 10-14 indicates moderate depression, 15-19 indicates moderately severe depression, and 20 or above indicates severe depression.
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 7 Nov 2024.
- Individual participant dataSharing planned: Yes. anonymized full set of raw data (PHQ-9 scores before and after participation) will be made available
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity in people with Depressive Symptoms, run by Je Bouge Pour Mon Moral at 1 site in France.
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 1 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 7 Nov 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 France. 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?
changes in depressive symptoms (time frame: PHQ-9 completed the day before and the day after the 3-week long exercise program). 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 7 Nov 2024.