Lifestyle Modification Program in the Prevention & Treatment of Depression

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03951350
Study type	Interventional
Source	Instituto de Investigación Sanitaria Aragón
Contact
Status	Completed
Phase	N/A
Start date	April 1, 2020
Completion date	February 1, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Lifestyle Modification Program in the Prevention and Treatment of Depression

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms