Clinical trial NCT06990035: Implementation of a Multiple Intervention to Promote Healthy Lifestyles in Patients With Depression
Official title: Implementazione di un Intervento Multiplo Per Promuovere Stili di Vita Sani in Pazienti Con Depressione: Uno Studio Clinico Controllato e Randomizzato
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Keywords: Major depressive disorder
Physical activity
Mediterranean Diet
Microbiome
Lead sponsor: IRCCS Centro San Giovanni di Dio Fatebenefratelli
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical trial aims to investigate whether an integrative approach combining education on the Mediterranean diet and physical activity (PA) can significantly reduce depressive symptomatology in individuals with major depressive disorder. The study will evaluate changes in depressive symptoms and assess biological modulations, including alterations in the gut microbiota and inflammatory markers, resulting from the PA intervention.

Participants will be randomized into two arms: the active control group will attend a series of lessons focused on the Mediterranean diet, while the experimental group will participate in the same dietary lessons combined with a structured PA program of 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of depression (DSM-5 criteria, American Psychiatric Association 2013).
* Depressive symptoms assessed using MADR, BDI, or ZDR scales.
* Ability to provide written informed consent.
* Self-reported moderate-intensity leisure physical activity of less than 150 minutes per week.

Exclusion Criteria:

* Patients with severe psychopathology.
* Medical contraindications to physical activity.
* Orthopedic problems or other conditions limiting physical fitness assessment or currently pregnant.
* Patients who underwent antibiotic/anti-inflammatory treatments in the last 3 months
* Active gastrointestinal diseases
* Autoimmune and/or chronic inflammatory disorders

Primary outcomes:
measure: MADR Scale for Depression
timeFrame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
measure: Beck Depression Inventory - II
timeFrame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
measure: Zung Self-Rating Depression Scale
timeFrame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
measure: Personal and Social Performance Scale
timeFrame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
measure: World Health Organization Quality of Life - Bref
timeFrame: Baseline (day 1); Week 6 (up to 6 weeks, mid-treatment); Week 12 (up to 12 weeks, end of treatment).
Secondary outcomes:
measure: Immunitary-related factors levels
timeFrame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).
measure: Gut Microbiome Composition
timeFrame: Baseline (day 1); Week 12 (up to 12 weeks, end of treatment).
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: IRCCS Centro San Giovanni fi Dio Fatebenefratelli
Study officials:
References: