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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Effectiveness of a Brief Psychological Mindfulness Based Intervention for the Treatment of Depression in Primary Care: Face-to-face Application, Treatment as Usual and Application Through ICTs

Conditions
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Depressive Disorder

Intervention / Treatment
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* Behavioral: Mindfulness


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAU+mindfulness applied face to face<br>4 sessions of 90 minutes/session Mindfulness based intervention applied in groups of 10-12 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is one month. | Behavioral: Mindfulness<br> <br> |
| Experimental: TAU + Mindfulness ICTs intervention<br>4 sessions of 60 minutes/session Mindfulness based intervention applied by ICTs (Internet-based program). The online intervention will be individual and interactive, which will be supported by multimedia material (videos, sound recordings, etc.) and will have internet support. The estimated duration of the online program is two months. | Behavioral: Mindfulness<br> <br> |
| No Intervention: Usual medical treatment (TAU)<br>In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory-II |  | Baseline | 
| Beck Depression Inventory-II | In the mindfulness-based intervention applied by ICTs | 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 | post-treatment 4 weeks from baseline in 4 weeks intervention group | 
| Beck Depression Inventory-II |  | Six-months follow-up | 
| Beck Depression Inventory-II |  | Twelve-months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sociodemographic data Gender, age, marital status, education, occupation, economical level |  | Baseline | 
| Health Survey 12 (SF-12) |  | Baseline | 
| Health Survey 12 (SF-12) | In the mindfulness-based intervention applied by ICTs | 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 | Post-treatment 4 weeks from baseline in 4 weeks intervention group | 
| Health Survey 12 (SF-12) |  | Six-months follow-up | 
| Health Survey 12 (SF-12) |  | Twelve-months follow-up | 
| EuroQol (EQ-5D). Health related quality of life |  | Baseline | 
| EuroQol (EQ-5D). Health related quality of life |  | Six-months follow-up | 
| EuroQol (EQ-5D). Health related quality of life |  | Twelve-months follow-up | 
| Positive and negative affect (PANAS) |  | Baseline | 
| Positive and negative affect (PANAS) | In the mindfulness-based intervention applied by ICTs | Post-treatment 8 weeks from baseline in 8 weeks intervention group | 
| Positive and negative affect (PANAS) | In the mindfulness-based intervention applied face-to-face and TAU group | Post-treatment 4 weeks from baseline in 4 weeks intervention group | 
| Positive and negative affect (PANAS) |  | Six-months follow-up | 
| Positive and negative affect (PANAS) |  | Twelve-months follow-up | 
| Five Facets and factors of mindfulness (FFMQ) |  | Baseline | 
| Five Facets and factors of mindfulness (FFMQ) |  | Six-months follow-up | 
| Five Facets and factors of mindfulness (FFMQ) |  | Twelve-months follow-up | 
| Pemberton Happiness Index (PHI) |  | Baseline | 
| Pemberton Happiness Index (PHI) |  | Six-months follow-up | 
| Pemberton Happiness Index (PHI) |  | Twelve-months follow-up | 
| Patient Health Questionnaire-9 |  | Baseline | 
| Patient Health Questionnaire-9 | In the mindfulness-based intervention applied by ICTs | Post-treatment 8 weeks from baseline in 8 weeks intervention group | 
| Patient Health Questionnaire-9 | In the mindfulness-based intervention applied face-to-face and TAU group | Post-treatment 4 weeks from baseline in 4 weeks intervention group | 
| Patient Health Questionnaire-9 |  | Six-months follow-up | 
| Patient Health Questionnaire-9 |  | twelve-months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Internet program, Depression, Cost-effectiveness