Effectiveness of a Brief Psychological Mindfulness Based Intervention for the Treatment of Depression in Primary Care

Universitat Jaume I120 enrolled

Overview

The aim of this study is to assess and compare a mindfulness low-intensity (4 weeks) psychological intervention for the treatment of depression in Primary Care between different groups: a mindfulness intervention applied face to face in group format, a control group that will receive treatment as usual (TAU) consisting of medical treatment and the same mindfulness intervention applied by Information and Communication Technologies (ICTs). The principal hypothesis is that face to face intervention will be more effective than TAU

The aim of this study is to assess and compare a mindfulness low-intensity (4 weeks) psychological intervention for the treatment of depression in Primary Care between different groups: 1) a face-to-face mindfulness intervention in group format (10-12 people/group), 2) a control group which will received primary care TAU (usual medical treatment) and 3) the same mindfulness intervention applied by Information and Communication Technologies (ICTs) (Internet-based program). All participants in the two psychological intervention groups will also receive usual medical treatment managed by their general practitioner. Each group will be composed of 40 participants with a total sample of 120. The principal hypothesis is that face to face intervention will be more effective than TAU. Secondary hypothesis, are: 1) The online computerized program will be more effective than TAU; 2) The differences between face-to-face and online format will be analyzed. Finally, a qualitative study will be conducted in order to analyze the feasibility, acceptance, barriers and causes of drop-outs and success, expectations, experiences and attitudes that could be obstacles or facilitators in the interventions, both in patients and in health professionals. This study will allow us to understand the experiences of depressed patients with these interventions and their differences.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Depressive Disorder

Interventions

MindfulnessBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be adult * Willingness to participate in the study and signing informed consent * Ability to understand and write Spanish. * DSM-5 diagnose of Major Depression or Dysthymia, mild or moderate depression expressed as score lower than 14 in the Patient Health Questionnaire (PHQ) * Duration of depressive symptoms 2 months or more * To have and to handle the computer and internet Exclusion Criteria: * Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.), * Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.), except for anxious pathology or personality disorders * Any medical, infectious or degenerative disease that may affect mood, presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk

Locations (1)

Universitat Jaume I

Castellon, Valencia, Spain

Outcomes

Primary Outcomes

Beck Depression Inventory-II

Time frame: Baseline

Beck Depression Inventory-II

In the mindfulness-based intervention applied by ICTs

Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group

Beck Depression Inventory-II

In the mindfulness-based intervention applied face-to-face and TAU group

Time frame: post-treatment 4 weeks from baseline in 4 weeks intervention group

Beck Depression Inventory-II

Time frame: Six-months follow-up

Beck Depression Inventory-II

Time frame: Twelve-months follow-up

Secondary Outcomes

Sociodemographic data Gender, age, marital status, education, occupation, economical level

Time frame: Baseline

Health Survey 12 (SF-12)

Time frame: Baseline

Health Survey 12 (SF-12)

In the mindfulness-based intervention applied by ICTs

Time frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group

Health Survey 12 (SF-12)

In the mindfulness-based intervention applied face-to-face and TAU group

Time frame: Post-treatment 4 weeks from baseline in 4 weeks intervention group

Health Survey 12 (SF-12)

Data from ClinicalTrials.gov

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