- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07422909
Bridging the Gap: Implementing BRIDGES (CCEMHA)
Bridging the Gap: Implementing BRIDGES (Brussels Resilience and Inclusion for Depression - Guidance, Exercise and Support) to Shape Adolescent Outpatient Mental Health Care. A Randomized Control Study Protocol
Study Overview
Status
Conditions
Detailed Description
Even though physical activity is recognized for its mental and physical health benefits, we find that adolescents going through a difficult psychological period often engage in very little of it. Current physical activity offerings do not always take into account their specific needs, preferences, or daily realities. That is why we have co-created a new approach with adolescents: BRIDGES, which stands for "In Brussels, Resilience and Inclusion for Depression through Guidance, Exercise, and Support." This project includes 18 30-minute sessions over 3 months with a physical therapist specializing in mental health, including individual follow-ups with advice and discussions, as well as putting you in touch with sports clubs or associations of your choice. The goal is to help you get moving again in your daily life, at your own pace and in a way that makes you feel good.
This study has a waiting list control group, so young people can either participate immediately or wait 6 months to participate.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Arnaud Philippot, PhD
- Phone Number: +32494827666
- Email: arnaud.philippot@kuleuven.be
Study Locations
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Uccle
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Brussels, Uccle, Belgium, 1180
- AREA+, Epsylon
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Contact:
- Vincent Dubois, Pr. and PhD
- Phone Number: +32477325890
- Email: v.dubois@epsylon.be
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All adolescents aged 12 to 19 with a diagnosis of depression who are receiving outpatient care through AREA+
- voluntary participation and accepting the randomisation
- being admitted at AREA+
- being able to stay focused for 30 minutes
- having a good knowledge of French
- physically inactive defined as not meeting the PA guidelines from World Health Organisation (28) following the corresponding age (i.e. at least 420 min of moderate to vigorous physical activity (MVPA) /week for those aged 12-17 and at least 150 min of MVPA /week for those aged 18 and 19 years
- living in Brussels
Exclusion Criteria:
- intellectual disability (defined as an intelligence quotient < 70)
- participants with serious medical problems or medical precautions prohibiting higher-intensity exercise (e.g., severe metabolic disorders, oncologic disease, unstable diabetes) according to the recommendations of the American College of Sports Medicine.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: The BRIDGES intervention
The BRIDGES intervention comprises 18 individualized sessions delivered over 12 weeks, combining physiotherapist-led counselling with structured support to transition into community-based physical activity. Motivational interviewing techniques facilitate collaborative, non-judgmental dialogue, helping adolescents resolve ambivalence about physical activity. Through reflective listening and open-ended questions, physiotherapists guide participants to explore their values, goals, and motivations, fostering a sense of ownership over the behaviour change process. Drawing on the self-determination theory, counselling targets three key psychological needs.Relevant opportunities from the AREA+ network, including local sports clubs and initiatives, are introduced in ways that align with adolescents' interests and intrinsic motivation. All participating clubs and associations are carefully selected. |
Described above
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No Intervention: Waiting-list
Accordingly, the comparator group will be a waitlist control receiving usual care, allowing evaluation of the added benefit of the intervention within the existing care context.
The usual standard outpatient care, which may include psychotherapy, medication management, or other usual clinical services.
No structured physical activity intervention is provided.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms
Time Frame: Throughout the entire study, during approximately 15 months
|
Patient Health Questionnaire-9 modified for Adolescents (PHQ-A) The PHQ-A is a brief instrument modified to adolescents used to assess the severity of depression (41).
It contains 9 items that are on a scale from 0 to 3, with the total score ranging from 0 to 27.
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Throughout the entire study, during approximately 15 months
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Physical activity levels
Time Frame: Throughout the entire study, during approximately 15 months
|
Physical Activity Vital Sign (PAVS) The PAVS is a screening tool used to assess patients' physical activity levels (37).
It consists of two questions: (a) on average, how many days per week do you engage in moderate to vigorous physical activity, and (b) on those days, how many minutes do you typically spend participating in moderate to vigorous physical activity?
The product of these responses (days × minutes) provides an estimate of the patient's average weekly minutes of physical activity in moderate to vigorous physical activity.
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Throughout the entire study, during approximately 15 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive symptoms (larger evaluation)
Time Frame: Throughout the entire study, during approximately 15 months
|
Beck Depression Index (BDI II) The BDI-II captures specific behavioral manifestations of depression.
It is a 21-item self-report inventory, with each item scored from 0 to 3 based on four statements reflecting symptom severity, yielding a total score ranging from 0 to 63.
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Throughout the entire study, during approximately 15 months
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Multidimensional Scale of Perceived Social Support (MSPSS)
Time Frame: Throughout the entire study, during approximately 15 months
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The Multidimensional Scale of Perceived Social Support (MSPSS) is a widely used self-report instrument designed to assess an individual's perception of social support from different sources (49).
The scale comprises 12 items, each rated on a 7-point Likert scale ranging from a score of 7 to 84.
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Throughout the entire study, during approximately 15 months
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Adapted Exercise self-efficacy (SEE)
Time Frame: Throughout the entire study, during approximately 15 months
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Exercise self-efficacy (SEE) is a key determinant of intention formation and engagement in physical activity.
In the original SEE, respondents rate their confidence in exercising three times per week for 20 minutes.
For the present study, the scale was adapted so that the target behavior reflects an individualized exercise goal defined by each adolescent, that is, the type of physical activity they wish to perform.
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Throughout the entire study, during approximately 15 months
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Astrand Rhyming test (ART)
Time Frame: Throughout the entire study, during approximately 15 months
|
Astrand Rhyming test (ART) ART is a single-stage cycle ergometer test, to measure the CRF fitness levels (assessed as an estimation of VO2 max)
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Throughout the entire study, during approximately 15 months
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Waist-to-height ratio (WHtR)
Time Frame: Throughout the entire study, during approximately 15 months
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Waist-to-height ratio (WHtR) WHtR is calculated as waist circumference (cm) divided by height (cm).
Waist circumference will be measured in standing position, midway between the lowest border of the rib cage and the superior border of the iliac crest, at the end of a normal expiration.
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Throughout the entire study, during approximately 15 months
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Motivational interviewing fidelity
Time Frame: Throughout the entire study, during approximately 15 months
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Fidelity to motivational interviewing (MI) will be assessed using a combination of observer- and participant-reported measures.
First, adherence to MI principles will be evaluated using the Independent Tape Rater Scale (ITRS), which is recommended for effectiveness studies
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Throughout the entire study, during approximately 15 months
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Client Perception of Motivational Interviewing
Time Frame: Throughout the entire study, during approximately 15 months
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the Client Perception of Motivational Interviewing (CPMI) scale captures participants' experiences of MI-consistent communication during sessions.
This combined approach enables assessment of both the technical and relational components of MI fidelity while remaining feasible within the constraints of a pilot implementation study.
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Throughout the entire study, during approximately 15 months
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The Health Care Climate Questionnaire
Time Frame: Throughout the entire study, during approximately 15 months
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Adolescents will complete the Health Care Climate Questionnaire (HCCQ) (61) to evaluate perceived autonomy support provided by the physiotherapist.
In addition, brief post-session feedback forms will invite participants to rate the extent to which they felt understood, empowered, and supported in setting their own goals-key indicators of SDT-congruent delivery.
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Throughout the entire study, during approximately 15 months
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Logbook
Time Frame: Throughout the entire study, during approximately 15 months
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the physiotherapist will fill out a logbook with their participation describing their presence, the context, the mechanisms at work, and clinical observations on the adolescents and their participation in physical activities
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Throughout the entire study, during approximately 15 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Implementation outcomes
Time Frame: Throughout the entire study, during approximately 15 months
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For the implementation assessment, PRISM will provide the overarching conceptual structure to examine organizational, individual, and system-level factors that influence delivery, uptake, and sustainability of the intervention (26).
Within this framework, the RE-AIM dimensions (Reach, Effectiveness, Adoption, Implementation, and Maintenance) will be systematically applied (27).
Reach will assess the proportion and representativeness of adolescents.
Effectiveness will evaluate changes in physical activity, depressive symptoms, and secondary outcomes.
Adoption will explore barriers and facilitators to participation and delivery from the perspectives of adolescents, clinicians, and community partners.
Implementation will monitor fidelity to motivational interviewing and self-determination theory principles.
Maintenance will evaluate the potential for long-term integration of the intervention.
Semi-structured interviews guided by PRISM domains will complement quantitative measures.
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Throughout the entire study, during approximately 15 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Arnaud Philippot, PhD, UCLouvain and KU Leuven
- Study Director: Marc Francaux, PhD, Université Catholique de Louvain
Publications and helpful links
General Publications
- Philippot, A., Coppens, M., Van Damme, T., Sluys, C., Francaux, M., Dubois, V., & Vancampfort, D. (2026). Combining the behavior change wheel framework with a co-design approach to develop an outpatient physical activity intervention for adolescents with depression: A blueprint. Manuscript accepted for publication.
- Miller, W. R., & Rollnick, S. (2012). Motivational interviewing: Helping people change. Guilford press.
- Philippot A, Dubois V, Lambrechts K, Grogna D, Robert A, Jonckheer U, Chakib W, Beine A, Bleyenheuft Y, De Volder AG. Impact of physical exercise on depression and anxiety in adolescent inpatients: A randomized controlled trial. J Affect Disord. 2022 Mar 15;301:145-153. doi: 10.1016/j.jad.2022.01.011. Epub 2022 Jan 7.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Behavior
- Depression
- Motor Activity
- Sedentary Behavior
- Motor Activity
- Movement
- Musculoskeletal Physiological Phenomena
- Musculoskeletal and Neural Physiological Phenomena
- Investigative Techniques
- Therapeutics
- Patient Care
- Health Services
- Health Care Facilities Workforce and Services
- Exercise
- Methods
- Palliative Care
Other Study ID Numbers
- CCEMHA
- JRDIC-2 a-b-c (Other Grant/Funding Number: Innoviris)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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