Lifestyle Interventions to Prevent Cognitive Deficits in Subjects With Depressive Symptoms: From Mechanisms to Clinical Practice (POWER)

IRCCS Centro San Giovanni di Dio Fatebenefratelli

Status: Not yet enrolling

Conditions: Depressive Symptoms; Metabolome; Inflammation; Physical Activity; Gut Microbiota; Major Depressive Disorder (MDD)

Treatments: Behavioral: Cognitive Training; Behavioral: Mediterranean Diet; Behavioral: Physical Activity

Study type: Interventional

Funder types: Other

Identifiers

NCT07009223

CERP-2024-23685718

Details and patient eligibility

About

The goal of this clinical study is to investigate if lifestyle changes can help prevent cognitive decline and reduce depressive symptoms in people between the ages of 50 and 80 with depressive symptoms or a diagnosis of major depression, but without signs of cognitive decline.

The main questions it aims to answer are:

• Does regular physical activity improve mood and memory in people who are depressed or have depressive symptoms?
• Does cognitive training help prevent mental difficulties in people at risk of cognitive decline?
• Do changes in diet and lifestyle alter the composition of the gut microbiota and immuno-related infiammatory factors?

Researchers will compare three different treatment groups to see which intervention is most effective in improving mental and cognitive health.

The participants:

• Will take part to online sessions on healthy eating based on the Mediterranean diet
• Some will do regular exercise, supervised by a personal trainer
• Others will do weekly cognitive training in small groups at the hospital
• They will provide blood and fecal samples and complete cognitive tests and clinical questionnaires at the beginning, at the end of the treatment (12 weeks), and after 3 months.

Enrollment: 120 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged between 50 and 80 years;
• Diagnosis of DDM according to DSM-5 or depressive symptoms (PHQ-9 or GDS-15 ≥ 5, the choice of test will be justified by the participant's age);
• No cognitive impairment or mild functional impairment (MMSE > 24)
• Ability to provide written informed consent.

Exclusion criteria

• Active gastrointestinal disorders;
• Autoimmune disorders;
• Chronic inflammatory disorders;
• Diagnosis of dementia;
• Use of antibiotics and/or anti-inflammatory drugs in the 8 weeks prior to the screening visit.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Group 1: Control group (CON)

Active Comparator group

Treatment:

Behavioral: Mediterranean Diet

Group 2: CON + physical activity

Experimental group

Treatment:

Behavioral: Physical Activity

Behavioral: Mediterranean Diet

Group 3: CON + Cognitive training

Experimental group

Treatment:

Behavioral: Mediterranean Diet

Behavioral: Cognitive Training