Clinical trial NCT05848973: NutriMind: A Combination of Healthy Diet and Psychotherapy to Treat Depression
Official title: The NutriMind Trial: A Low-cost Randomized Trial Combining a Healthy Diet and Psychotherapy to Treat Depressive Symptoms Among University Students - The Case of Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: University of Oslo
name: Makerere University
First posted: 2023-05-08
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The NutriMind trial will include three intervention groups, namely; the healthy diet group, the psychotherpay group (Mindfulness-Based Cognitive Therapy-MBCT), a combined healthy diet and MBCT group and a control group with no intervention. Pending the financial situation investigators may also consider having two arms: Intervention (Diet and MBCT) and control.
Primary purpose: TREATMENT

Brief summary: University students in Low- and Middle-Income Countries (LMIC) continue to face growing rates of depression, a common mental health problem. Adding to this burden is the mental health treatment gap, necessitating the need to identify new treatment methods that can easily be implemented at a large scale.

This project will test if a healthy diet combined with mindfulness-based cognitive therapy can reduce depressive symptoms among university students in Uganda, a low resource country.

The burden of depression is high in sub-Saharan African countries, largely worsened by poverty, hunger and poor public health service, and lately the COVID-19 pandemic. These factors increase psychological distress among young people in sensitive periods of life, such as students who are about to choose their career and establish family. Successfully managing depression in LMIC is likely to depend on low-cost treatment that can easily be managed to large target populations, yet still be at the scientific forefront, proof-based, and culturally acceptable. This can possibly be obtained with an intervention combining healthy diet and cognitive behavioral therapy based on mindfulness principles.

While healthy diets and mindfulness cognitive therapy individually can partly lessen the burden of depression, these two therapeutic modalities have not been tested in combination among university students in sub-Saharan Africa, i.e. a synergistic effect that is still to be studied.

With the NutriMind Trial, its investigators focus on a neglected global mental health challenge, namely depression among university students in Uganda.

Detailed description: Despite being a major global health issue for decades, Common Mental Health Problems (CMHPs), such as depression, remains neglected. University students worldwide are facing growing rates of CMHPs, with few or no mental health services available. The burden of CMHPs is highest in low- and middle-income countries (LMICs), largely worsened by poverty, hunger and poor public health governance. These factors increase stress, in particular among students who are about to choose their career, both in academia and later in the work force. Successfully managing CMHPs in LMICs is likely to depend on treatment methods that can easily be administered to the target population, yet still be at the scientific forefront, evidence-based, and culturally acceptable.

Wellness-based therapy includes behavioural changes like mindfulness-based cognitive therapies and nutritional interventions. While systematic reviews and randomized controlled trials show that such treatment modalities may lessen the burden of CMPHs, including depression, they have not been tested among university students in LMICs. The NutriMind investigators will therefore perform a randomized controlled trial to test if mindfulness-based cognitive therapy and/or a healthy diet (modified Mediterranean diet) will reduce depressive symptoms among university students in Uganda, a low-income country. In addition to evaluate the clinical outcomes, the investigators will analyse biomarkers for various metabolic pathways, as studies have related e.g. inflammation and oxidative stress to depression. Recent studies also indicate that the microbiome can play a role in depression through orchestrating metabolic signals to the brain. Notwithstanding these ambitious goals, our experienced and cross-disciplinary team puts us in an advantageous position to successfully accomplish this work.

The overall goal of the project is thus to test pragmatic lifestyle interventions in a population at high risk of depression in a low-resource setting and link the study outcomes to biological processes. If the investigators succeed, they can readily identify those who will improve from the intervention and provide an opportunity to respond to current gaps in mental health treatment, in particular in LMICs. In doing so, this novel project will address the World Health Organization's appeal for immediate and sustained action to reduce mental health illnesses, and the Lancet Commission's call for a substantial global shift toward healthy dietary patterns, as well as United Nations Sustainable Development Goals, in particular nos. 3 (good health and well-being) and 4 (quality education).

Eligibility criteria: Inclusion criteria:

* Those who score between 16 and 25 on the CES-D scale
* Completed \>1 study-year of study and have \>2 study-years before graduation
* Not using any medication regularly that might interfere with study adherence or - outcomes
* Giving consent to participate

Exclusion criteria:

* Not being diagnosed with chronic disorder or cancer
* Not being pregnant
* Not having food allergy- or intolerance
* Not having experienced recent bereavement or major personal loss (e.g. income or divorce)

Primary outcomes:
measure: Change from baseline to 24 months in depressive symptoms using the Center for Epidemiological Studies - Depression (CES-D) score among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
Secondary outcomes:
measure: Change from baseline to 24 months in depressive symptoms using the Beck Depression Inventory-II (BDI-II) score among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
measure: The health economic costs of each of the three intervention arms compared with the control group.
timeFrame: 24 months
measure: Change from baseline to 24 months in body weight among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
measure: Change from baseline to 24 months in body height among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
measure: Change from baseline to 24 months in body composition among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
measure: Change from baseline to 24 months in blood cholesterol levels among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
measure: Change from baseline to 24 months in blood CRP levels among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
measure: Change from baseline to 24 months in fecal microbiota composition levels among the study participants randomized to each of the three intervention arms compared with the controls.
timeFrame: 24 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Makerere University
state: Central Uganda
Study officials:
affiliation: University of Bergen
name: Prudence A Friberg
role: PRINCIPAL_INVESTIGATOR
References: