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Mediterranean Lifestyle Program in the Prevention and Treatment of Depression

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ClinicalTrials.gov Identifier: NCT03951350
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Bárbara Oliván-Blázquez, Instituto de Investigación Sanitaria Aragón

Brief Summary:

Objective: To analyze the effectiveness and cost-utility as a coadjuvant treatment of subclinical, mild or moderate depression of the recommendations of Mediterranean lifestyles intervention in primary care patients.The effectiveness of a monitoring by Information and communications technology (ICTs), and the effectiveness of the intervention in chronic comorbid pathology will also be analyzed.

Methodology:

Design: Randomized multicentre pragmatic clinical trial in 3 parallel groups. Subjects: Primary care patients with subclinical, mild or moderate depression. Sample Size: We will recruit 250 patients to achieve a reduction of at least 4.8 points on the Beck depression scale.

Interventions:

  1. Usual antidepressant treatment with psychological advice and / or psychotropic drugs by the primary care physician (Treatment As Usual - TAU).
  2. TAU + Mediterranean lifestyle (ML). Program that will work weekly in 6 sessions of 2 hours in a group to improve the following aspects: daily physical activity + adherence to the Mediterranean diet pattern + sleep hygiene + careful exposure to the ambient light.
  3. TAU + ML + ICTs: recommendations of Mediterranean lifestyle (previous point) + monitoring using ICTs.

Measurements: The main variable will be the depressive symptomatology evaluated by the BDI II and the secondary variables will be the quality of life, the use of health and social resources, and personal variables related to adherence to the program.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Mediterranean lifestyles (ML) Behavioral: Information communication technologies (ICTs) Not Applicable

Detailed Description:

Patients with depressive symptoms who have not developed severe depression assigned to the Mediterranean lifestyle program as complementary treatment (TAU + ML) will improve their depressive symptoms to a greater extent than patients assigned to the usual treatment group by family doctor (TAU). This improvement will be even greater in a group in which the Mediterranean lifestyle program is reinforced with ICT monitoring (TAU + ML + ICTs).

A) Main hypothesis:

The two proposed coadjuvant interventions added to the usual treatment prescribed by their family doctor (TAU + ML) and (TAU + ML + ICTs) achieve an improvement in the depressive symptoms measured by the Beck II Self-Applied Depression Inventory (BDI-II) of at least 4.8 points with respect to the treatment with psychological advice and / or habitual psychotropic drugs (TAU).

B) Secondary hypotheses:

Both coadjuvant interventions are cost-effective according to the societal point of view, being more cost-effective the intervention of Mediterranean lifestyle supported with a monitoring by means of ICTs.

The modification of lifestyle will also have a positive effect on comorbidity with other chronic physical diseases such as diabetes, hypertension, chronic heart disease and diseases of lipid metabolism.

The personal factors of self-efficacy, activation, sense of coherence, health literacy and procrastination, will directly influence the adherence to patterns of lifestyle modification, and therefore the success of the intervention.

Objectives:

The general objective of this multicenter project is to analyze the effectiveness of adjuvant treatment to the usual treatment administered by the family doctor (TAU) of two programs: Mediterranean lifestyle (TAU + ML); and Mediterranean lifestyle supported by frequent monitoring through ICTs (TAU + ML + ICTs) in people with subclinical, mild or moderate depression in primary care.

The secondary objectives are:

  • Evaluate the cost-effectiveness of the proposed interventions by administering the CSRI questionnaire.
  • Analyze the effectiveness of interventions in the associated chronic physical pathology (diabetes, hypertension, chronic heart disease and diseases of lipid metabolism).
  • Analyze the correlation and weight of personal factors (self-efficacy, activation, sense of coherence, health literacy and procrastination) in the completion of the lifestyle modification program.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Cost-effectiveness of a Mediterranean Lifestyle Program in the Prevention and Treatment of Subclinical, Mild and Moderate Depression in Primary Care
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Regular treatment with psychotropic drugs and / or psychological counseling (Treatment as usual - TAU) prescribed by their family doctor.
Experimental: Mediterranean lifestyle (ML)
It will consist of 6 group sessions, with a duration of 2 hours each session.
Behavioral: Mediterranean lifestyles (ML)
Improving adherence to the Mediterranean diet pattern, improving compliance with World Health Organization (WHO) recommendations regarding activity daily physical, improved sleep hygiene and increased careful exposure to ambient light.

Experimental: Mediterranean lifestyle (ML) + ICTs
It will consist of 6 group sessions, with a duration of 2 hours each session.
Behavioral: Mediterranean lifestyles (ML)
Improving adherence to the Mediterranean diet pattern, improving compliance with World Health Organization (WHO) recommendations regarding activity daily physical, improved sleep hygiene and increased careful exposure to ambient light.

Behavioral: Information communication technologies (ICTs)
Monitoring by means of ICTs (activity wristband or smart watch) related to the frequency and intensity of physical activity, sleep quality and weekly monitoring in the group related to diet and exposure to sunlight (ML + ICTs).




Primary Outcome Measures :
  1. Beck II Self-Applied Depression Inventory (BDI-II) [ Time Frame: Change from Baseline severity of depression at 1 week after intervention, after 6 months and after 12 months. ]
    It is self-report inventory for measuring the severity of depression, with 21-question multiple-choice, each answer being scored on a scale value of 0 to 3. The standardized cutoffs are: 0-13: minimal depression. 14-19: mild depression. 20-28: moderate depression. 29-63: severe depression (Beck et al., 1996).


Secondary Outcome Measures :
  1. International Neuropsychiatric Interview (MINI) [ Time Frame: Baseline ]
    It is a short-term structured diagnostic interview that explores the main psychiatric disorders of Axis I of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and International Classification of Diseases (ICD-10) (Ferrando et al., 2000).

  2. Comorbidity with chronic diseases [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    Comorbidity with chronic diseases will be collected according to International Classification of Diseases (ICD-10): diabetes (glucose concentration (mg / dl), glycated hemoglobin (%), creatinine), arterial hypertension, diseases of lipid metabolism. In patients with chronic heart disease, coagulation variables will be added. Anthropometric measures will also be collected (Weight: A precision scale will be used, easy to calibrate and this will be done every day, after each measurement the return to zero level will be checked. Size: It will be measured in vertical position. Perimeter of the waist: The midpoint between the last rib and the iliac crest will be located). They will be collected by clinical history in the last blood test or control measurement made by your family doctor or nurse (as long as it was taken in less than 3 months). Otherwise, their family doctor will be asked for a control analysis.

  3. European Quality of Life-5 Dimensions questionnaire (EQ-5D) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]

    Generic instrument of quality of life related to health. The EQ-5D scores will be used to calculate the quality adjusted for years of life (QALY) during the monitoring period by adjusting the length of time affected by the health result by the value of the utility.

    It contains five dimensions of health (mobility, personal care, daily activities, pain / discomfort and anxiety / depression) and each of them has three levels of seriousness (without problems, some problems or moderate problems and serious problems).

    The second part of the EQ-5D is a Visual Analogue Scale (VAS) of 20 centimeters, millimeter, ranging from 0 (worse health status imaginable) to 100 (best imaginable health status). In it, the individual must mark the point in the vertical line that best reflects the assessment of their global health status today (Badia et al., 1999).


  4. Physical activity questionnaire (IPAQ-SF) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    To assess the levels of habitual physical activity in the period of the last 7 days. It has 9 items and records the activity of four intensity levels: vigorous-intensity activity such, moderate-intensity activity such, walking and sitting (Kim, Park & Kang, 2012).

  5. Adhesion to the Mediterranean Diet questionnaire (PREDIMED) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    A 14-item tool of adherence to the Mediterranean diet. Less than 9 points, means low adhesion, greater than 9 points, it means good adherence (Martínez-González et al., 2012).

  6. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    To measure the quality and patterns of sleep in the older adult. It differentiates "poor" from "good" sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month. There are several questions that request the evaluation of the client's bedmate or roommate, these are not scored, nor reflected in the attached instrument (Buysse, 1989).

  7. Patient Activation Questionnaire (PAM) in relation to the management of their health [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    It evaluates the patient's perceived knowledge, skills, and confidence to engage in self-management activities. It has 13 items, a Likert scale from 1 (strongly disagree) to 4 (strongly agree). They score between 0 and 100 and it places the individual at one of four levels of activation (Hibbard et al., 2004).

  8. Social support questionnaire (MOS) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    It is a self-report instrument consisting of four separate social support subscales (emotional/informational, tangible, affectionate, and positive social interaction) and an overall functional social support index. It has 19 items, a five-point Likert scale. A higher score for an indicates more support (de la Revilla Ahumada, 1991).

  9. The Self-Efficacy Scale [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    To measure general self-efficacy (individuals' belief in their ability to perform well in a variety of situations) and social self-efficacy. It contains 23 items that are rated on a 14-point scale with the anchors agree strongly and disagree strongly. Higher scores indicate higher levels of self-efficacy (Sherer et al.,1982).

  10. Sense of coherence questionnaire of Antonovsky [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    It values the personal disposition towards the valuation of the vital experiences. It measures the sense of coherence, comprehensibility, manageability, meaningfulness. It has 13 items that score ranges between 13 and 91 points (Antonovsky, 1993).

  11. Health Literacy Europe questionnaire (HLS-EUQ16) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    To measure the level of health literacy. It can indicate that the probability of functional literacy in limited health is high, a possibility of functional literacy in limited health, and a functional health literacy in adequate health (Sørensen et al., 2015).

  12. Irrational Procrastination Scale (IPS) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    To measure general procrastination (dysfunctional delay). It has nine items, rated on a 5-point Likert scale, with higher scores (after reversal of the three procrastination-inconsistent items) indicating higher degree of procrastination (Guilera, 2018).

  13. Client Service Receipt Inventory (CSRI) [ Time Frame: Baseline, 1 week after intervention, after 6 months, after 12 months. ]
    To collect information on the whole range of services and supports study participants may use. It collects retrospectively the data on the use of services during the previous 6 months (e.g., rates of service use of individual services, mean intensity of service use, rates of use of accommodation over time) (Knapp, 1995).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: Over 18 years.
  • Severity of subclinical depression, mild or moderate according to the Inventory for Beck Depression (score between 10 and 30).
  • Duration of depression of at least 2 months.
  • Understand perfectly spoken and written Spanish.
  • Give informed consent.

Exclusion Criteria:

  • Suffer another disease that affects the central nervous system (organic brain pathology or that has suffered a traumatic brain injury of any severity, dementia, etc.).
  • Another psychiatric diagnosis or serious psychiatric illness (dependence or substance abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.) with the exception of anxious pathology or personality disorders (collected through a medical history).
  • Presence of a medical disease, infectious or degenerative serious uncontrolled, that may interfere in the affective symptoms.
  • Presence of delirious ideas or hallucinations congruent or not with the state of mind at the time of the study.
  • Important risk of suicide.
  • Pregnancy, lactation.
  • Participation in another clinical trial in the last 6 months.
  • To be receiving structured psychotherapeutic treatment by a mental health professional.
  • Practitioners of mindfulness, yoga, meditation or similar practices in the last 6 months, with formal practice at least once a week.
  • Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951350


Contacts
Layout table for location contacts
Contact: Bárbara Oliván-Blázquez 0034636441315 bolivan@unizar.es
Contact: Alejandra Aguilar-Latorre 0034685304966 aaguilar@iisaragon.es

Sponsors and Collaborators
Instituto de Investigación Sanitaria Aragón

Publications:
Sanz J, Garcia Vera MP, Espinosa R, Fortun M, Vazquez C. Adaptación española del Inventario para la Depresión de Beck II: Propiedades psicométricas en pacientes con trastornos psicológicos. Clínica y Salud 2005; 16: 121-42.
Drummond MF, Sculpher MJ, Torrance GW, O'Brien B, Stoddart GL: Methods for the Economic Evaluation of Health Care Programmes. Oxford, Oxford University Press; 2005.
Knapp M and (PSSRU and Centre for Economics of Mental Health, Institute of Psychiatry, University of Kent): Economic Evaluation of Mental Health Care.Ashgate Publishing Group; 1995.
Sherer M, Maddux JE, Mercandante B, Prentice-Dunn S, Jacobs B, Rogers RW. The Self-Efficacy Scale: Construction and Validation. Psychol Rep 1982;51(2):663 -71.
Ferrando, L., Bobes, J., Gibert, J., Soto, M. y Soto, O. (2000). MINI. Entrevista Neuropsiquiátrica Internacional. Versión en Español 5.0.0. DSM-IV. Traducida por L. Franco-Alfonso, L. Franco. Bajada de http://entomologia.rediris.es /pub/bscw.cgi/ d602335/ MINI/Entrevista Neuropsiquiátrica Internacional.pdf

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Responsible Party: Bárbara Oliván-Blázquez, Professor University of Zaragoza, Instituto de Investigación Sanitaria Aragón
ClinicalTrials.gov Identifier: NCT03951350     History of Changes
Other Study ID Numbers: PI18/01336
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bárbara Oliván-Blázquez, Instituto de Investigación Sanitaria Aragón:
mediterranean lifestyles
depression
primary health care
adjuvant treatment
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders