Influence of Nutrition in Depression Treatment (INDEPT)

NCT05745194 | Recruiting

• 1 other identifier: PTDC/SAU-NUT/3321/2020
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 2

Brief Summary

The hypothesis to be tested by this study is that an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with elevated inflammation biomarkers, namely C-reactive protein (CRP) and Interleukin 6 (IL-6) diagnosed with Major Depression Disorder (MDD), under treatment with antidepressant medication for a period of time less than or equal to 6 months. The main aim of this study is to understand if promoting the adherence to the MedDiet, as an adjuvant strategy in the treatment of MDD, is effective in decreasing symptoms of depression in MDD patients, with elevated levels of inflammation biomarkers. Other specific objectives of the study are

1. 1.To assess the association between adherence to MedDiet and changes in inflammatory biomarkers;
2. 2.To assess the association between changes in inflammatory biomarkers with symptoms of MDD;
3. 3.To evaluate the association between adherence to MedDiet and effectiveness of psychiatric treatment of MDD;
4. 4.To characterize the association between adherence to MedDiet and changes in health-related quality of life
5. 5.To evaluate the economic cost-effectiveness of dietary counselling, as an adjuvant treatment in MDD.

Conditions

Major Depressive Disorder - MDD

Keywords

Depression; Major Depressive Disorder; Nutritional Intervention; Randomized Controlled Trial; Mediterranean Diet

Outcome Measures

Primary Outcomes (1)

• Changes in symptoms of MDD

  Symptoms of depression will be assessed with the self-administered Beck Depression Inventory-II (BDI-II) scale. To measure changes in the main outcome, the score of the BDI-II will be used categorically, considering the cut-offs proposed: 0-13 minimal depression; 14-19 mild depression; 20-28 moderate depression; 29-63 severe depression. The success measure will be a downgrade of category in the severity of depressive symptoms. The analysis of the score of the BDI-II will also be performed using the scale score as a continuous variable.

  Baseline, 12-weeks, 6-months, and 12-months after the baseline assessment

Secondary Outcomes (1)

• Inflammation biomarkers (IL-6 and/or CRP)

  Baseline, 12-weeks, 6-months, and 12-months after the baseline assessment

Other Outcomes (4)

• Adherence to the Mediterranean Diet according to the 14-point Mediterranean Diet Adherence Screener Scale

  Baseline,12-weeks, 6-months, and 12-months after the baseline assessment

• Health-related quality of life

  Baseline, 12-week, 6-months, and 12-months after the baseline assessment

• Healthcare use cost

  Baseline,12-weeks, 6-months, and 12-months after the baseline assessment

Study Arms (2)

Interventional Group

EXPERIMENTAL

Interventional group with six nutritional counselling consultations promoting the adherence to the MedDiet and TAU for MDD

Behavioral: Promotion of adherence to the MedDiet

Control Group

NO INTERVENTION

Individuals with TAU for MDD

Interventions

Promotion of adherence to the MedDiet BEHAVIORAL

Participants will be followed in six individual nutrition consultations with a duration of 30 to 60 minutes. The consultations will be focused on promoting the adherence to the MedDiet. The nutritional intervention will be personalized to each individual ad libitum, without calories or macronutrients restriction and without the goal to promote weight change. The intervention will begin with an initial assessment of the dietary patterns of the participants in which the nutritionist will identify potential behavioural changes to promote adjustments in dietary habits and therefore adherence to the MedDiet. The intervention will promote positive recommendations (behaviours recommended to follow) and negative recommendations (behaviours recommended to reduce or eliminate) (26), using the strategy and MedDiet definition proposed by Estruch et al. in the "Primary Prevention of Cardiovascular Disease with a Mediterranean Diet" study (3). The participants will also maintain MDD TAU.

Interventional Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18-70 years old
• Able to understand and provide informed consent
• Able to read and write
• Have a diagnosis of MDD (according to ICD-10 F32.0; F32.1; F32.2; F32.9; F33.0; F33.1; F33.2; F33.9 criteria)
• Score on the Beck Depression Inventory-II scale (BDI-II) \> 13;
• Elevated biomarkers of inflammation (CRP \> 3mg/l or IL-6 ≥ 2pg/ml )
• Able to follow a MedDiet without impeditive physical or religious limitations, allergies or intolerances
• Being under pharmacological treatment for depressive disorder

You may not qualify if:

• Diagnosis of autoimmune diseases, thyroid dysfunction or cancer
• Diagnosis of bipolar disorder, psychotic disorders, eating disorders
• Self-reported acute infection 2 weeks prior to the blood sample collection
• Pregnancy or lactation
• Glucocorticoid medication
• Prescribed with NMDA Receptor Antagonists
• Under treatment with brain stimulation techniques for the depressive episode
• Currently participating in another intervention targeting diet, physical exercise, or MDD treatment

Sponsors & Collaborators

• Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA: lead
• University of Lisbon: collaborator
• Instituto Politécnico de Leiria: collaborator
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (2)

Hospital de Beatriz Ângelo - Hospital de Loures, EPE

Loures, Lisbon District, 2674-514, Portugal

RECRUITING

Centro Hospitalar de Leiria - Hospital Santo André

Leiria, 2410-197, Portugal

RECRUITING

Related Publications (7)

• Yang C, Wardenaar KJ, Bosker FJ, Li J, Schoevers RA. Inflammatory markers and treatment outcome in treatment resistant depression: A systematic review. J Affect Disord. 2019 Oct 1;257:640-649. doi: 10.1016/j.jad.2019.07.045. Epub 2019 Jul 5.

  PMID: 31357161 BACKGROUND

• Osimo EF, Baxter LJ, Lewis G, Jones PB, Khandaker GM. Prevalence of low-grade inflammation in depression: a systematic review and meta-analysis of CRP levels. Psychol Med. 2019 Sep;49(12):1958-1970. doi: 10.1017/S0033291719001454. Epub 2019 Jul 1.

  PMID: 31258105 BACKGROUND

• Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25.

  PMID: 23432189 BACKGROUND

• Beck AT, Steer RA, Ball R, Ranieri W. Comparison of Beck Depression Inventories -IA and -II in psychiatric outpatients. J Pers Assess. 1996 Dec;67(3):588-97. doi: 10.1207/s15327752jpa6703_13.

  PMID: 8991972 BACKGROUND

• Garcia-Conesa MT, Philippou E, Pafilas C, Massaro M, Quarta S, Andrade V, Jorge R, Chervenkov M, Ivanova T, Dimitrova D, Maksimova V, Smilkov K, Ackova DG, Miloseva L, Ruskovska T, Deligiannidou GE, Kontogiorgis CA, Pinto P. Exploring the Validity of the 14-Item Mediterranean Diet Adherence Screener (MEDAS): A Cross-National Study in Seven European Countries around the Mediterranean Region. Nutrients. 2020 Sep 27;12(10):2960. doi: 10.3390/nu12102960.

  PMID: 32992649 BACKGROUND

• Gregorio MJ, Rodrigues AM, Salvador C, Dias SS, de Sousa RD, Mendes JM, Coelho PS, Branco JC, Lopes C, Martinez-Gonzalez MA, Graca P, Canhao H. Validation of the Telephone-Administered Version of the Mediterranean Diet Adherence Screener (MEDAS) Questionnaire. Nutrients. 2020 May 22;12(5):1511. doi: 10.3390/nu12051511.

  PMID: 32455971 BACKGROUND

• Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.

  PMID: 9626712 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Maria João Heitor, PhD

  Instituto de Saúde Ambiental, Faculdade de Medicina da Universidade de Lisboa, Portugal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuno Sousa-Santos, BSc

CONTACT

00351913295919; nunoneto@edu.lisboa.pt

Cátia Clara, BSc

CONTACT

00351965053469; study.indept@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The researchers responsible for the data collection at the end of the trial and follow up assessments will be hired and trained by the study staff exclusively for that task to mitigate potential bias. The statistical analysis will be performed by researchers, prior to the unblinding of participants. The unmasking of participants group allocation will only occur after the statistical analysis of the clinical trial results at 12-week is performed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Psychiatry, Principal Investigator

Model Details: The study will follow a randomized open controlled trial design with concealment of participants allocation to the researchers involved in data collection at the end of the trial and follow-up assessments. Researchers participating in the statistical analysis of the trial´s data will also be concealed to group allocation. Participants meeting all inclusion criteria will be randomized to (a) the intervention group: six nutritional consultations with a registered nutritionist promoting adherence to the MedDiet and TAU or (b) the control group: only exposed to TAU for MDD.

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 27, 2023
• Study Start: June 5, 2023
• Primary Completion: January 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)