Clinical trial NCT03034343: Effectiveness of a Brief Psychological Mindfulness Based Intervention for the Treatment of Depression in Primary Care
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder
Keywords: Mindfulness
Internet program
Depression
Cost-effectiveness
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
Collaborators: name: Research Unit in Primary Care of Aragon (Spain)
First posted: 2017-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Beck Depression Inventory-II
timeFrame: Baseline
measure: Beck Depression Inventory-II
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Beck Depression Inventory-II
timeFrame: post-treatment 4 weeks from baseline in 4 weeks intervention group
measure: Beck Depression Inventory-II
timeFrame: Six-months follow-up
measure: Beck Depression Inventory-II
timeFrame: Twelve-months follow-up
Secondary outcomes:
measure: Sociodemographic data Gender, age, marital status, education, occupation, economical level
timeFrame: Baseline
measure: Health Survey 12 (SF-12)
timeFrame: Baseline
measure: Health Survey 12 (SF-12)
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Health Survey 12 (SF-12)
timeFrame: Post-treatment 4 weeks from baseline in 4 weeks intervention group
measure: Health Survey 12 (SF-12)
timeFrame: Six-months follow-up
measure: Health Survey 12 (SF-12)
timeFrame: Twelve-months follow-up
measure: EuroQol (EQ-5D). Health related quality of life
timeFrame: Baseline
measure: EuroQol (EQ-5D). Health related quality of life
timeFrame: Six-months follow-up
measure: EuroQol (EQ-5D). Health related quality of life
timeFrame: Twelve-months follow-up
measure: Positive and negative affect (PANAS)
timeFrame: Baseline
measure: Positive and negative affect (PANAS)
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Positive and negative affect (PANAS)
timeFrame: Post-treatment 4 weeks from baseline in 4 weeks intervention group
measure: Positive and negative affect (PANAS)
timeFrame: Six-months follow-up
measure: Positive and negative affect (PANAS)
timeFrame: Twelve-months follow-up
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Baseline
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Six-months follow-up
measure: Five Facets and factors of mindfulness (FFMQ)
timeFrame: Twelve-months follow-up
measure: Pemberton Happiness Index (PHI)
timeFrame: Baseline
measure: Pemberton Happiness Index (PHI)
timeFrame: Six-months follow-up
measure: Pemberton Happiness Index (PHI)
timeFrame: Twelve-months follow-up
measure: Patient Health Questionnaire-9
timeFrame: Baseline
measure: Patient Health Questionnaire-9
timeFrame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
measure: Patient Health Questionnaire-9
timeFrame: Post-treatment 4 weeks from baseline in 4 weeks intervention group
measure: Patient Health Questionnaire-9
timeFrame: Six-months follow-up
measure: Patient Health Questionnaire-9
timeFrame: twelve-months follow-up
Other outcomes:
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Baseline
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Six-months follow-up
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Twelve-months follow-up
Locations:
city: Castellon de la Plana
country: Spain
facility: Universitat Jaume I
state: Valencia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.