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

NCT05848973 | Recruiting DMC

• 1 other identifier: 441814
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  24 months

• The health economic costs of each of the three intervention arms compared with the control group.

  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.

  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.

  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.

  24 months

Study Arms (4)

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.

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.

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

Other: Healthy Diet; Behavioral: Mindfulness-based cognitive therapy (MBCT)

Control

NO INTERVENTION

No particular intervention will be provided to the control group.

Interventions

Healthy Diet 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.

Healthy diet; Healthy diet and MBCT combined

Mindfulness-based cognitive therapy (MBCT) 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; Mindfulness-based cognitive therapy (MBCT)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Bergen: lead
• University of Oslo: collaborator
• Makerere University: collaborator

Study Sites (1)

Makerere University

Kampala, Central Uganda, +26, Uganda

RECRUITING

Related Publications (1)

• 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.

  PMID: 39261786 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Diet, Healthy; Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Prudence A Friberg

  University of Bergen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prudence A Friberg, PhD

CONTACT

+4794094826; prudence.friberg@uib.no

Per O Iversen

CONTACT

+47 415 59 532; p.o.iversen@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data collection teams will be blinded to the allocation arms throughout the trial in order to minimise measurement bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: May 8, 2023
• Study Start: January 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Approximately 3 years from the start of the study.When all collected data has been analysed and published the results in an open access journal.
• Access Criteria: Project website that will be established when the study implementation starts

Locations

UG (1)