An interventional study of Promotion of adherence to the MedDiet in Major Depressive Disorder - MDD, sponsored by Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA. Recruiting at 2 sites in Portugal. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA · Not applicable, Interventional, and Treatment
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
The study will have a duration of 12 weeks, with a randomized parallel-group open controlled trial design, with two parallel groups with an allocation ratio of 1:1 - (a) intervention arm with six nutritional consultations with a registered nutritionist, promoting adherence to MedDiet, in addition to MDD Treatment-As-Usual (TAU) and (b) control group arm benefitting only from MDD TAU. A follow up assessment will be performed at 6- and 12-months.
Having into consideration an attrition of 40 percentage at the end of the intervention, the minimum sample size estimated is 190 (95 per arm).
The main outcome of the trial, changes in symptoms of depression, will be evaluated using the Beck Depression Inventory Second Edition (BDI-II).
To test the study´s hypothesis, namely if an intervention promoting adherence to the MedDiet can decrease symptoms of depression in patients with MDD and elevated inflammation biomarkers, the following objectives will be assessed.
The main objective of the trial is:
1.To assess the effectiveness of dietary counselling promoting MedDiet, as an adjuvant treatment of MDD, to decrease depressive symptoms in adults diagnosed with MDD and having elevated inflammation biomarkers (CRP, IL-6).
Specific objectives are:
This study is a 12-week multicentre randomized parallel-group open controlled trial, with a follow up assessment at 6- and 12-months after baseline data collection, with two parallel groups with an allocation ratio of 1:1. - (a) intervention arm with six nutrition consultations with a registered nutritionist, promoting adherence to MedDiet, in addition to MDD treatment as usual (TAU) and (b) control group benefitting only from MDD TAU. Participants will be individuals diagnosed with a first episode of MDD, according to the "F32 Depressive episode" (F32.0; F32.1; F32.2) classification of the Tenth Revision of the International Classification of Diseases (ICD-10), under treatment with antidepressant medication for a period of time less than or equal to 6 months, attending to outpatient consultations.
Potential participants will be invited to enrol by their medical doctors from the participating recruitment centres. The invitation will be made at regular medical appointments including primary care consultations and outpatient psychiatric consultations in one of the participant centers. After signing the informed consent, CRP and IL-6 levels will be tested. Participants with increased inflammatory biomarkers, meeting all other inclusion criteria will be randomized to (a) the intervention arm or (b) the control arm of the study, in a 1:1 ratio, using a computer-generated list of random numbers stratified by center in variable blocks of size 2, 4 and 6. Treatment allocation will be concealed from the researchers, using sequentially numbered, opaque, sealed envelopes.
The study will use a convenience sample from patients diagnosed with MDD attending to outpatient consultations in one for the participating clinics.
Considering a 2-sided significance level of 5 percent and a power of 80 percent and having into consideration an attrition of 40 percent at the end of the intervention, the minimum sample size estimated is 190 (95 per arm). Estimating a prevalence of elevated inflammation in 30 percentage of MDD patients and 10 percentage of patients that don't meet other inclusion criteria, the number of recruited participants estimated is 700.
Participants allocated to the intervention group will attend six nutrition consultations, performed by a register nutritionist in weeks 1, 2, 4, 6, 8 and 10. The intervention will be personalized to each participant and will promote adherence to the Mediterranean Diet, ad libitum, without calories or macronutrients restriction or recommendation for weight change.
The intervention will follow a similar approach to the one proposed by Estruch et al. in the "Primary Prevention of Cardiovascular Disease with a Mediterranean Diet" study.
The intervention will contemplate the following recommendations:
Positive recommendations (promotion of the intake of the following foods):
Negative recommendations (eliminate or drastically reduce the following foods):
Training of the nutritionists delivering the intervention will be provided prior to the beginning of recruitment and during the duration of the trial in MDD, therapeutic relationship, trauma and Mediterranean Diet.
Data analysis and reporting will be performed in accordance with Consolidated Standards of Reporting Trials (CONSORT) guidelines.
Primary analysis will include all randomized participants, following an intention-to-treat (ITT) approach. Baseline characteristics of the participants, by group, will be reported using descriptive statistics and compared by χ\^2 and t-test for independent samples (or equivalent non-parametric test).
To evaluate the effectiveness of nutritional counselling promoting MedDiet, the scale BDI-II will be used categorically in accordance with the standardized cutoffs: minimal depression (0-13), mild depression (14-19), moderate depression (20-28), severe depression (29-63). The success measure will be a decrease in category in the severity of depressive symptoms. The proportion of participants with a decrease in depression severity symptoms category according to the BDI-II (main outcome) will be compared between control and intervention groups using generalized linear mixed models.
Further adjustment for relevant covariates, as supportive analysis, will be made. Secondary analyses, including the analysis of the main outcome measure (BDI-II) as a continuous variable, will be conducted using (Generalized) Linear Mixed Models, as appropriate. For each outcome, results for either intervention and control group, and estimates of effect size with a 95 percent confidence interval will be reported. All analyses will be performed using R and R Studio version 3.5.3 and R Studio version 1.3.618 (or another updated version in the moment of analysis), assuming a significance level of 5 percent.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's planned enrollment of 190 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Interventional group with six nutritional counselling consultations promoting the adherence to the MedDiet and TAU for MDD
Behavioral: Promotion of adherence to the MedDiet
Individuals with TAU for MDD
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.
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.
Time frame: Baseline, 12-weeks, 6-months, and 12-months after the baseline assessment
Inflammation biomarkers (IL-6 and/or CRP)
Identification of statistically significant variation of IL-6 and/or CRP concentrations in blood between baseline and other moments of assessment. CRP and IL-6 will be measured using a Atellica CH Analyzer.
Time frame: Baseline, 12-weeks, 6-months, and 12-months after the baseline assessment
Adherence to the Mediterranean Diet according to the 14-point Mediterranean Diet Adherence Screener Scale
The Adherence to the Mediterranean Diet will be assessed by the validated Portuguese version of the 14-point Mediterranean Diet Adherence Screener. This instrument evaluates the intake of foods typical of the MedDiet. The scale presents a result from 0 to 14 points, with a higher score indicating greater adherence to the mediterranean dietary pattern. Changes between baseline and other assessments will be analysed using the score of the scale as a continuous variable..
Time frame: Baseline,12-weeks, 6-months, and 12-months after the baseline assessment
Health-related quality of life
Changes in health-related quality of life between baseline and other assessment moments will be accessed by the World Health Organization Quality of Life - Brief (WHOQOL-BREF). The global score of the scale ranges from 0 to 100 points, with a higher score indicating a higher quality of life.
Time frame: Baseline, 12-week, 6-months, and 12-months after the baseline assessment
Healthcare use cost
The estimation cost of healthcare resource use will be assessed using: number of days of hospital admission, general care medical appointments and specialty medical appointments, sessions of massage and physiotherapy, psychology appointments and ocupational therapy appointments.
Time frame: Baseline,12-weeks, 6-months, and 12-months after the baseline assessment
Absenteeism
Absence from work will be estimated in hours.
Time frame: Baseline,12-weeks, 6-months, and 12-months after the baseline assessment
Plan to share: No
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Associacao para Investigacao e Desenvolvimento da Faculdade de Medicina - CETERA