Depressive Disorder
Conditions
Keywords
Mindfulness, Internet program, Depression, Cost-effectiveness
Brief summary
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
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.
Interventions
BEHAVIORALMindfulness
Sponsors
Research Unit in Primary Care of Aragon (Spain)
Universitat Jaume I
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Beck Depression Inventory-II | Baseline |
Secondary
| Measure | Time frame |
|---|---|
| Sociodemographic data Gender, age, marital status, education, occupation, economical level | Baseline |
| Health Survey 12 (SF-12) | Baseline |
| EuroQol (EQ-5D). Health related quality of life | Baseline |
| Five Facets and factors of mindfulness (FFMQ) | Baseline |
| Pemberton Happiness Index (PHI) | Baseline |
| Patient Health Questionnaire-9 | Baseline |
| Positive and negative affect (PANAS) | Baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Client Service Receipt Inventory (CSRI) | Baseline | This inventory includes the number of times health services have been used.Collect the sick leave, the number of hospital admissions, the number of times that the person attends an emergency service, number of times that is attended by a healthcare professional and finally collects the medication. There is no maximum or minimum score, it simply provides information. |
Countries
Spain
Outcome results
None listed