- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03034343
Effectiveness of a Brief Psychological Mindfulness Based Intervention for the Treatment of Depression in Primary Care
March 30, 2020 updated by: Universitat Jaume I
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
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
Study Overview
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.
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Valencia
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Castellon de la Plana, Valencia, Spain, 12071
- Universitat Jaume I
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TAU+mindfulness applied face to face
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.
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|
Experimental: TAU + Mindfulness ICTs intervention
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.
|
|
No Intervention: Usual medical treatment (TAU)
In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Inventory-II
Time Frame: Baseline
|
Baseline
|
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Beck Depression Inventory-II
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
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In the mindfulness-based intervention applied by ICTs
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Post-treatment 8 weeks from baseline in 8 weeks intervention group
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Beck Depression Inventory-II
Time Frame: post-treatment 4 weeks from baseline in 4 weeks intervention group
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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
Time Frame: Six-months follow-up
|
Six-months follow-up
|
|
Beck Depression Inventory-II
Time Frame: Twelve-months follow-up
|
Twelve-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame: Baseline
|
Baseline
|
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Health Survey 12 (SF-12)
Time Frame: Baseline
|
Baseline
|
|
Health Survey 12 (SF-12)
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
|
In the mindfulness-based intervention applied by ICTs
|
Post-treatment 8 weeks from baseline in 8 weeks intervention group
|
Health Survey 12 (SF-12)
Time Frame: Post-treatment 4 weeks from baseline in 4 weeks intervention group
|
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)
Time Frame: Six-months follow-up
|
Six-months follow-up
|
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Health Survey 12 (SF-12)
Time Frame: Twelve-months follow-up
|
Twelve-months follow-up
|
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EuroQol (EQ-5D). Health related quality of life
Time Frame: Baseline
|
Baseline
|
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EuroQol (EQ-5D). Health related quality of life
Time Frame: Six-months follow-up
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Six-months follow-up
|
|
EuroQol (EQ-5D). Health related quality of life
Time Frame: Twelve-months follow-up
|
Twelve-months follow-up
|
|
Positive and negative affect (PANAS)
Time Frame: Baseline
|
Baseline
|
|
Positive and negative affect (PANAS)
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
|
In the mindfulness-based intervention applied by ICTs
|
Post-treatment 8 weeks from baseline in 8 weeks intervention group
|
Positive and negative affect (PANAS)
Time Frame: Post-treatment 4 weeks from baseline in 4 weeks intervention group
|
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)
Time Frame: Six-months follow-up
|
Six-months follow-up
|
|
Positive and negative affect (PANAS)
Time Frame: Twelve-months follow-up
|
Twelve-months follow-up
|
|
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Baseline
|
Baseline
|
|
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Six-months follow-up
|
Six-months follow-up
|
|
Five Facets and factors of mindfulness (FFMQ)
Time Frame: Twelve-months follow-up
|
Twelve-months follow-up
|
|
Pemberton Happiness Index (PHI)
Time Frame: Baseline
|
Baseline
|
|
Pemberton Happiness Index (PHI)
Time Frame: Six-months follow-up
|
Six-months follow-up
|
|
Pemberton Happiness Index (PHI)
Time Frame: Twelve-months follow-up
|
Twelve-months follow-up
|
|
Patient Health Questionnaire-9
Time Frame: Baseline
|
Baseline
|
|
Patient Health Questionnaire-9
Time Frame: Post-treatment 8 weeks from baseline in 8 weeks intervention group
|
In the mindfulness-based intervention applied by ICTs
|
Post-treatment 8 weeks from baseline in 8 weeks intervention group
|
Patient Health Questionnaire-9
Time Frame: Post-treatment 4 weeks from baseline in 4 weeks intervention group
|
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
Time Frame: Six-months follow-up
|
Six-months follow-up
|
|
Patient Health Questionnaire-9
Time Frame: twelve-months follow-up
|
twelve-months follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Client Service Receipt Inventory (CSRI)
Time Frame: 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.
|
Baseline
|
Client Service Receipt Inventory (CSRI)
Time Frame: Six-months follow-up
|
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)
Time Frame: Twelve-months follow-up
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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. Erratum In: Gen Hosp Psychiatry. 2006 May-Jun;28(3):266.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2016
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
June 1, 2020
Study Registration Dates
First Submitted
January 11, 2017
First Submitted That Met QC Criteria
January 24, 2017
First Posted (Estimate)
January 27, 2017
Study Record Updates
Last Update Posted (Actual)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 30, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PI16/0202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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