Lifestyle Modification Program in the Prevention and Treatment of Depression

Instituto de Investigación Sanitaria Aragón

Status: Completed

Conditions: Depression

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03951350

PI18/01336

Details and patient eligibility

About

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.

Enrollment: 159 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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159 participants in 3 patient groups

Control (TAU)

No Intervention group

Description:

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

Lifestyle Modification Program (LMP)

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle Modification Program (LMP)

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

Lifestyle Modification Program (LMP) + ICTs

Experimental group

Description:

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

Treatment:

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