DepressionNutriMindNCT05848973
NutriMind: A Combination of Healthy Diet and Psychotherapy to Treat Depression
A study testing Healthy Diet and Mindfulness-based cognitive therapy (MBCT) in people with Depression, run by University of Bergen at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression
- What is being tested?
- Healthy Diet and Mindfulness-based cognitive therapy (MBCT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jan 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Uganda1 site, 1 recruiting
- Recruiting
Makerere University
Kampala, Central Uganda, +26
Archileo N Kaaya, +256-772440046, kaaya.archileo48@gmail.com
Grace M Muhoozi, +256 772 487890, gmuhoozi15@gmail.com
About this study
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
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.
Read more
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.
Read the 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).
- Conditions
- Depression
- Being tested
- Healthy Diet, Mindfulness-based cognitive therapy (MBCT)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy DietOther
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy diet | Active comparator | 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. Receives: Other: Healthy Diet |
| Mindfulness-based cognitive therapy (MBCT) | Active comparator | 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. Receives: Behavioral: Mindfulness-based cognitive therapy (MBCT) |
| Healthy diet and MBCT combined | Active comparator | The study participants randomized to this arm will receive both the healthy diet intervention and the MBCT intervention Receives: Other: Healthy Diet; Behavioral: Mindfulness-based cognitive therapy (MBCT) |
| Control | No intervention | No particular intervention will be provided to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Depressive symptoms will be assessed using the CES-D score from before to after the intervention. CES-D scores range from 0 to 60, with higher scores indicating greater depressive symptoms. The CES-D provides cut-off scores (16 or greater) to aid in identifying individuals at risk for clinical depression, with good sensitivity and specificity and high internal consistency.
Measured: 24 months
Secondary outcomes (8)
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.
BDI-II is a self-reported, validated tool for screening depressive symptoms on a 4-point scale with 21 questions, giving a range of 0-63. A score > 10 strongly indicates depression.
Measured: 24 months
The health economic costs of each of the three intervention arms compared with the control group.
Health economic costs of the interventions on change in depressive symptoms will be evaluated using standard cost-effectiveness methods including sensitivity analysis. Investigators will convert the CES-D and BDI-II scores into a generic health measure (e.g. disability/quality adjusted life years) for this purpose.
Measured: 24 months
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.
Weight in kilograms will be measured using a scale (to the nearest 100 g)
Measured: 24 months
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.
Height in meters will be measured using a scale (to the nearest cm)
Measured: 24 months
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.
Body composition (i.e. percentage of fat, bone, water and lean body mass) will be assessed with bio-impedance.
Measured: 24 months
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.
Blood cholesterol (mmol/l) will be analyzed using standard biochemistry methods, levels above the reference range indicate increased risk of cardiovascular disease.
Measured: 24 months
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.
Blood CRP (mg/l) will be analyzed using standard biochemistry methods, levels above the reference range indicate increased risk of cardiovascular disease.
Measured: 24 months
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.
Microbiota (percentage distribution of various bacteria) will be analysed feces using 16S rRNA amplicon sequencing. Less diverse microbiota composition may indicate increased risk of depression and other non-communicable diseases.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start1 Jan 2024
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, Makerere University
- Responsible party
- Principal investigator, Prudence Atukunda Friberg, University of Bergen
- Investigators
- Prudence A Friberg, Principal investigator, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848973
- Sponsor's protocol ID
- 441814
- Acronym
- NutriMind
- Status last verified
- May 2024
- First submitted
- 27 Mar 2023
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Informed Consent Form (ICF) will be shared with all study participants and was approved by Uganda Institutional Review Board. Clinical Study Report (CSR) will be published on the trial website that is going to be created during the study. There is signed Material Transfer Agreement (MTA) between the collaborating universities that specifies data sharing process
Publications
Kardel KR, Iversen PO, Kaaya AN, Muhoozi G, Veierod MB, Wangen KR, Borosund E, Friberg PA. A pragmatic randomized trial to examine the effect of combining healthy diet with mindfulness cognitive therapy to reduce depressive symptoms among university students in a low-resource setting: protocol for the NutriMind Project. BMC Psychiatry. 2024 Sep 11;24(1):610. doi: 10.1186/s12888-024-06056-9.
PubMed 39261786
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05848973
- Acronym / sponsor ID
- NutriMind / 441814
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- University of Oslo, Makerere University
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy diet | Active comparator | Other: Healthy DietThe 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. |
| Mindfulness-based cognitive therapy (MBCT) | Active comparator | Behavioral: 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. |
| Healthy diet and MBCT combined | Active comparator | Other: Healthy Diet, Behavioral: Mindfulness-based cognitive therapy (MBCT)The study participants randomized to this arm will receive both the healthy diet intervention and the MBCT intervention |
| Control | No intervention | –No particular intervention will be provided to the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy DietThe 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. | Other | Healthy diet, Healthy diet and MBCT combined |
| 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. | Behavioural | Healthy diet and MBCT combined, Mindfulness-based cognitive therapy (MBCT) |
Primary outcome
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.
Time frame: 24 months
Depressive symptoms will be assessed using the CES-D score from before to after the intervention. CES-D scores range from 0 to 60, with higher scores indicating greater depressive symptoms. The CES-D provides cut-off scores (16 or greater) to aid in identifying individuals at risk for clinical depression, with good sensitivity and specificity and high internal consistency.
8 secondary outcomes
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.
Time frame: 24 months
The health economic costs of each of the three intervention arms compared with the control group.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
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.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 39261786Kardel KR, Iversen PO, Kaaya AN, Muhoozi G, Veierod MB, Wangen KR, Borosund E, Friberg PA. A pragmatic randomized trial to examine the effect of combining healthy diet with mindfulness cognitive therapy to reduce depressive symptoms among university students in a low-resource setting: protocol for the NutriMind Project. BMC Psychiatry. 2024 Sep 11;24(1):610. doi: 10.1186/s12888-024-06056-9.
- Individual participant dataSharing planned: Yes. Informed Consent Form (ICF) will be shared with all study participants and was approved by Uganda Institutional Review Board. Clinical Study Report (CSR) will be published on the trial website that is going to be created during the study. There is signed Material Transfer Agreement (MTA) between the collaborating universities that specifies data sharing process
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prudence A Friberg principal investigator
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Diet and Mindfulness-based cognitive therapy (MBCT) in people with Depression, run by University of Bergen at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prudence A Friberg, PhD (+4794094826, prudence.friberg@uib.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05848973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.