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| Name | Class |
|---|---|
| Research Unit in Primary Care of Aragon (Spain) | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAU+mindfulness applied face to face | Experimental | 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. |
|
| TAU + Mindfulness ICTs intervention | Experimental | 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. |
|
| Usual medical treatment (TAU) | No Intervention | In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral |
|
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Client Service Receipt Inventory (CSRI) | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Jaume I | Castellon | Valencia | 12071 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24497236 | Background | Andersson G, Titov N. Advantages and limitations of Internet-based interventions for common mental disorders. World Psychiatry. 2014 Feb;13(1):4-11. doi: 10.1002/wps.20083. | |
| 16516070 | Background | Backenstrass M, Joest K, Frank A, Hingmann S, Mundt C, Kronmuller KT. Preferences for treatment in primary care: a comparison of nondepressive, subsyndromal and major depressive patients. Gen Hosp Psychiatry. 2006 Mar-Apr;28(2):178-80. doi: 10.1016/j.genhosppsych.2005.10.001. |
| Label | URL |
|---|---|
| Laboratory of Psychology and Technology of the University Jaume I | View source |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D003863 | Depression |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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 |
| Baseline |
| Client Service Receipt Inventory (CSRI) | 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. | Six-months follow-up |
| Client Service Receipt Inventory (CSRI) | 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. | Twelve-months follow-up |
| 19192368 | Background | Cuijpers P, van Straten A, van Schaik A, Andersson G. Psychological treatment of depression in primary care: a meta-analysis. Br J Gen Pract. 2009 Feb;59(559):e51-60. doi: 10.3399/bjgp09X395139. |
| 19045965 | Background | Kuyken W, Byford S, Taylor RS, Watkins E, Holden E, White K, Barrett B, Byng R, Evans A, Mullan E, Teasdale JD. Mindfulness-based cognitive therapy to prevent relapse in recurrent depression. J Consult Clin Psychol. 2008 Dec;76(6):966-78. doi: 10.1037/a0013786. |
| 31619196 | Derived | Lopez-Montoyo A, Quero S, Montero-Marin J, Barcelo-Soler A, Beltran M, Campos D, Garcia-Campayo J. Effectiveness of a brief psychological mindfulness-based intervention for the treatment of depression in primary care: study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2019 Oct 16;19(1):301. doi: 10.1186/s12888-019-2298-x. |