NutriMind: A Combination of Healthy Diet and Psychotherapy to Treat Depression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-12-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The data collection teams will be blinded to the allocation arms throughout the trial in order to minimise measurement bias.

Study Groups

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Healthy diet

The study participants randomized to this arm will be given advice about consuming a healthy diet, i.e. a diet rich in vegetables/fruits and wholegrain/fibre, fish, olive oil; and moderate in red meat and dairy products. The participants will receive 8 weekly, one hour group sessions delivered by trained nutritionists.

Group Type ACTIVE_COMPARATOR

Healthy Diet

Intervention Type OTHER

The targeted study participants will be given advice about healthy dietary intakes. This will entail promotion of foods rich in vegetables/fruits and wholegrain/fibre, fish, olive oil; moderate in lean red meat and low-fat diary products). To be concrete, the study investigators will target energy (E%) from macronutrients as follows: 42 E% total fat (≥ 22 E% from monounsaturated fatty acids, 10 E% from polyunsaturated fatty acids and \<10 E% saturated fatty acids), 35 E% carbohydrate, 15 E% protein and ≤ E 5% alcohol. Importantly, this will meet all Recommended Dietary Intake requirements for adults.

Mindfulness-based cognitive therapy (MBCT)

The study participants randomized to this arm will be taught the purpose and application of MBCT, namely to modify cognitive and effective processes in the management of depressive symptoms as well as relapse prevention among those with residual depressive symptoms. It is a structured 8-weeks' intervention program delivered in groups, with an all-day practice session around week six and regular reunion sessions thereafter.

Group Type ACTIVE_COMPARATOR

Mindfulness-based cognitive therapy (MBCT)

Intervention Type BEHAVIORAL

MBCT is a skills-based intervention comprising a structured 8-week group intervention program to be delivered in groups of study participants, with an all-day practice session around week six and regular reunion sessions thereafter.

Healthy diet and MBCT combined

The study participants randomized to this arm will receive both the healthy diet intervention and the MBCT intervention

Group Type ACTIVE_COMPARATOR

Healthy Diet

Intervention Type OTHER

The targeted study participants will be given advice about healthy dietary intakes. This will entail promotion of foods rich in vegetables/fruits and wholegrain/fibre, fish, olive oil; moderate in lean red meat and low-fat diary products). To be concrete, the study investigators will target energy (E%) from macronutrients as follows: 42 E% total fat (≥ 22 E% from monounsaturated fatty acids, 10 E% from polyunsaturated fatty acids and \<10 E% saturated fatty acids), 35 E% carbohydrate, 15 E% protein and ≤ E 5% alcohol. Importantly, this will meet all Recommended Dietary Intake requirements for adults.

Mindfulness-based cognitive therapy (MBCT)

Intervention Type BEHAVIORAL

MBCT is a skills-based intervention comprising a structured 8-week group intervention program to be delivered in groups of study participants, with an all-day practice session around week six and regular reunion sessions thereafter.

Control

No particular intervention will be provided to the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Healthy Diet

The targeted study participants will be given advice about healthy dietary intakes. This will entail promotion of foods rich in vegetables/fruits and wholegrain/fibre, fish, olive oil; moderate in lean red meat and low-fat diary products). To be concrete, the study investigators will target energy (E%) from macronutrients as follows: 42 E% total fat (≥ 22 E% from monounsaturated fatty acids, 10 E% from polyunsaturated fatty acids and \<10 E% saturated fatty acids), 35 E% carbohydrate, 15 E% protein and ≤ E 5% alcohol. Importantly, this will meet all Recommended Dietary Intake requirements for adults.

Intervention Type OTHER

Mindfulness-based cognitive therapy (MBCT)

MBCT is a skills-based intervention comprising a structured 8-week group intervention program to be delivered in groups of study participants, with an all-day practice session around week six and regular reunion sessions thereafter.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)

Eligible Sex

ALL

Accepts Healthy Volunteers

No