High- vs Low-Frequency Exercise for Depression in Adolescents

NCT06677723 | Completed DMC

• 1 other identifier: Depression_adolescent_1st_step
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Depressive Symptoms

Outcome Measures

Primary Outcomes (1)

• 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.

  PHQ-9 completed the day before and the day after the 3-week long exercise program

Study Arms (3)

RUN_1*60

EXPERIMENTAL

exercise training including one weekly running session (60-min long) for 3 weeks

Behavioral: physical activity

RUN_4*15

EXPERIMENTAL

exercise training including 4 weekly running sessions (15-min long) for 3 weeks

Behavioral: physical activity

CONTROL

NO INTERVENTION

control group

Interventions

physical activity BEHAVIORAL

moderate-intensity running

RUN_1*60; RUN_4*15

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• baseline PHQ-9 score \> 9 (i.e., "moderate depression")

You may not qualify if:

• unability to read and understand French language
• specific medical contraindications for physical activity

Sponsors & Collaborators

• Je Bouge Pour Mon Moral: lead

Study Sites (1)

JeBougePourMonMoral

Reims, 51100, France

Location

MeSH Terms

Conditions

Depression

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: March 11, 2024
• Primary Completion: May 13, 2024
• Study Completion: May 20, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available on reasonable email request as soon as the study will be published in an academic journal
• Access Criteria: Researchers wishing to apply for IPD should outlining the research purpose for which they wish to use the data

Locations

FR (1)