Lifestyle Modification Program in the Prevention and Treatment of Depression

NCT03951350 | Completed

• 1 other identifier: PI18/01336
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Major depression is a highly prevalent pathology that is currently the second most common cause of disease-induced disability in our society. The onset and continuation of depression may be related to a wide variety of biological and psychosocial factors, many of which are linked to different lifestyle aspects. Therefore, health systems must design and implement health promotion and lifestyle modification programs, taking into account personal factors and facilitators. The main objective of this work is to analyze the utility and cost-effectiveness of an adjunctive treatment program for subclinical, mild or moderate depression in Primary Care patients, based on healthier lifestyle recommendations. Secondary objectives include the analysis of the effectiveness of the intervention in comorbid chronic pathology and the measurement of the influence of personal factors on lifestyle modification. Methods and analysis: A randomized, multicenter pragmatic clinical trial with 3 parallel groups consisting of primary healthcare patients suffering from subclinical, mild or moderate depression. The following interventions will be used: 1. Usual antidepressant treatment with psychological advice and/or psychotropic drugs prescribed by the General Practitioner (treatment-as-usual, TAU). 2. TAU + Lifestyle Modification Program (LMP). A program to be imparted in 6 weekly 90-minute group sessions, intended to improve the following aspects: behavioral activation + daily physical activity + adherence to the Mediterranean diet pattern + sleep hygiene + careful exposure to sunlight. 3. TAU + LMP + ICTs: healthy lifestyle recommendations (TAU+LMP intervention) + monitoring using ICTs (a wearable smartwatch). The primary outcome will be the depressive symptomatology and the secondary outcomes will be the quality of life, the use of health and social resources, personal variables related to program adherence (patient activation in their own health, self-efficacy, sense of coherence, health literacy and procrastination) and chronic comorbid pathology. Data will be collected before and after the intervention, with 6- and 12-month follow-ups.

Conditions

Depression

Keywords

Lifestyle modifications; Depression; primary health care; Diet; Exercise; Sunlight exposure; Sleep patterns

Outcome Measures

Primary Outcomes (1)

• Beck II Self-Applied Depression Inventory (BDI-II)

  The primary outcome will be measured using the BDI-II (Beck et al., 1996). This is a self-report inventory for measuring the severity of depression, consisting of 21 multiple-choice questions with each answer being scored on a scale ranged from 0 to 3. It was translated and validated into Spanish with a reliability of .89 (Sanz et al., 2005). The standardized cutoffs are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; 29-63: severe depression.

  Change from baseline, immediately after the intervention and at six and 12-month follow-up.

Secondary Outcomes (13)

• International Neuropsychiatric Interview (MINI)

  Baseline

• Comorbidity with chronic diseases

  Change from baseline, immediately after the intervention and at six and 12-month follow-up.

• European Quality of Life-5 Dimensions questionnaire (EQ-5D)

  Change from baseline, immediately after the intervention and at six and 12-month follow-up.

• Physical activity questionnaire (IPAQ-SF)

  Change from baseline, immediately after the intervention and at six and 12-month follow-up.

• Mediterranean Diet Adherence Screener (MEDAS)

  Change from baseline, immediately after the intervention and at six and 12-month follow-up.

Study Arms (3)

Control (TAU)

NO INTERVENTION

Patients will follow the usual treatment provided by their GP (treatment-as-usual, TAU).

Lifestyle Modification Program (LMP)

EXPERIMENTAL

It will consist of 6 weekly group sessions (lasting 90 minutes each).

Behavioral: Lifestyle Modification Program (LMP); Behavioral: Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)

Lifestyle Modification Program (LMP) + ICTs

EXPERIMENTAL

It will consist of 6 weekly group sessions (lasting 90 minutes each).

Behavioral: Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)

Interventions

Lifestyle Modification Program (LMP) BEHAVIORAL

Patients will follow TAU and LMP. This program will consist of 6 weekly group sessions (lasting 90 minutes each) led by an experienced psychologist and complemented by PowerPoint presentations. The content is the following: 1. Presentation of the project and psychoeducation on depression. 2. Behavior activation. 3. Sleep hygiene habits and careful exposure to sunlight. 4. Physical activity. 5. Adherence to the Mediterranean diet. 6. Summary of previous sessions with practical final suggestions.

Lifestyle Modification Program (LMP)

Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs) BEHAVIORAL

Patients will follow TAU and LMP and will be monitored using a wearable smart wristwatch that will track their daily sleep patterns and physical activity (LMP+ICTs).

Lifestyle Modification Program (LMP); Lifestyle Modification Program (LMP) + ICTs

Eligibility Criteria

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

You may qualify if:

• Individuals over the age of 18.
• Both sexes.
• Having a duration of depression symptoms of at least 2 months.
• Who perfectly understand written and spoken Spanish.
• Who have provided their informed consent.

You may not qualify if:

• Suffering from another disease that affects the central nervous system (organic brain pathology or having suffered a traumatic brain injury of any severity, dementia).
• Having another psychiatric diagnosis or serious psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders) with the exception of anxious pathology or personality disorders (collected through a medical history and from the Mini-International Neuropsychiatric Interview (MINI) (Ferrando, Bobes, \& Gibert, 2000)).
• Presence of a serious or uncontrolled medical, infectious or degenerative illness that may interfere with the affective symptoms.
• Presence of delirium or hallucinations, risk of suicide, pregnancy or lactation.
• Patients who have participated in another clinical trial over the past 6 months or who are currently in psychotherapy.
• Who practice mindfulness, yoga, meditation or similar practices over the past 6 months, engaging in 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria Aragón: lead

Study Sites (1)

Alejandra Aguilar-Latorre

Zaragoza, 50009, Spain

Location

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MeSH Terms

Conditions

Depression; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor University of Zaragoza

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 15, 2019
• Study Start: April 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: February 1, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)