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

Primary Purpose

Depressive Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder focused on measuring Mindfulness, Internet program, Depression, Cost-effectiveness

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitat Jaume I

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

TAU+mindfulness applied face to face

TAU + Mindfulness ICTs intervention

Usual medical treatment (TAU)

Arm Description

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.

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.

In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment.

Outcomes

Primary Outcome Measures

Beck Depression Inventory-II
Beck Depression Inventory-II
In the mindfulness-based intervention applied by ICTs
Beck Depression Inventory-II
In the mindfulness-based intervention applied face-to-face and TAU group
Beck Depression Inventory-II
Beck Depression Inventory-II

Secondary Outcome Measures

Sociodemographic data Gender, age, marital status, education, occupation, economical level
Health Survey 12 (SF-12)
Health Survey 12 (SF-12)
In the mindfulness-based intervention applied by ICTs
Health Survey 12 (SF-12)
In the mindfulness-based intervention applied face-to-face and TAU group
Health Survey 12 (SF-12)
Health Survey 12 (SF-12)
EuroQol (EQ-5D). Health related quality of life
EuroQol (EQ-5D). Health related quality of life
EuroQol (EQ-5D). Health related quality of life
Positive and negative affect (PANAS)
Positive and negative affect (PANAS)
In the mindfulness-based intervention applied by ICTs
Positive and negative affect (PANAS)
In the mindfulness-based intervention applied face-to-face and TAU group
Positive and negative affect (PANAS)
Positive and negative affect (PANAS)
Five Facets and factors of mindfulness (FFMQ)
Five Facets and factors of mindfulness (FFMQ)
Five Facets and factors of mindfulness (FFMQ)
Pemberton Happiness Index (PHI)
Pemberton Happiness Index (PHI)
Pemberton Happiness Index (PHI)
Patient Health Questionnaire-9
Patient Health Questionnaire-9
In the mindfulness-based intervention applied by ICTs
Patient Health Questionnaire-9
In the mindfulness-based intervention applied face-to-face and TAU group
Patient Health Questionnaire-9
Patient Health Questionnaire-9

Full Information

First Posted
January 11, 2017
Last Updated
March 30, 2020
Sponsor
Universitat Jaume I
Collaborators
Research Unit in Primary Care of Aragon (Spain)
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1. Study Identification

Unique Protocol Identification Number
NCT03034343
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I
Collaborators
Research Unit in Primary Care of Aragon (Spain)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Mindfulness, Internet program, Depression, Cost-effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU+mindfulness applied face to face
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU + Mindfulness ICTs intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual medical treatment (TAU)
Arm Type
No Intervention
Arm Description
In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness
Primary Outcome Measure Information:
Title
Beck Depression Inventory-II
Time Frame
Baseline
Title
Beck Depression Inventory-II
Description
In the mindfulness-based intervention applied by ICTs
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Beck Depression Inventory-II
Description
In the mindfulness-based intervention applied face-to-face and TAU group
Time Frame
post-treatment 4 weeks from baseline in 4 weeks intervention group
Title
Beck Depression Inventory-II
Time Frame
Six-months follow-up
Title
Beck Depression Inventory-II
Time Frame
Twelve-months follow-up
Secondary Outcome Measure Information:
Title
Sociodemographic data Gender, age, marital status, education, occupation, economical level
Time Frame
Baseline
Title
Health Survey 12 (SF-12)
Time Frame
Baseline
Title
Health Survey 12 (SF-12)
Description
In the mindfulness-based intervention applied by ICTs
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Health Survey 12 (SF-12)
Description
In the mindfulness-based intervention applied face-to-face and TAU group
Time Frame
Post-treatment 4 weeks from baseline in 4 weeks intervention group
Title
Health Survey 12 (SF-12)
Time Frame
Six-months follow-up
Title
Health Survey 12 (SF-12)
Time Frame
Twelve-months follow-up
Title
EuroQol (EQ-5D). Health related quality of life
Time Frame
Baseline
Title
EuroQol (EQ-5D). Health related quality of life
Time Frame
Six-months follow-up
Title
EuroQol (EQ-5D). Health related quality of life
Time Frame
Twelve-months follow-up
Title
Positive and negative affect (PANAS)
Time Frame
Baseline
Title
Positive and negative affect (PANAS)
Description
In the mindfulness-based intervention applied by ICTs
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Positive and negative affect (PANAS)
Description
In the mindfulness-based intervention applied face-to-face and TAU group
Time Frame
Post-treatment 4 weeks from baseline in 4 weeks intervention group
Title
Positive and negative affect (PANAS)
Time Frame
Six-months follow-up
Title
Positive and negative affect (PANAS)
Time Frame
Twelve-months follow-up
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Baseline
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Six-months follow-up
Title
Five Facets and factors of mindfulness (FFMQ)
Time Frame
Twelve-months follow-up
Title
Pemberton Happiness Index (PHI)
Time Frame
Baseline
Title
Pemberton Happiness Index (PHI)
Time Frame
Six-months follow-up
Title
Pemberton Happiness Index (PHI)
Time Frame
Twelve-months follow-up
Title
Patient Health Questionnaire-9
Time Frame
Baseline
Title
Patient Health Questionnaire-9
Description
In the mindfulness-based intervention applied by ICTs
Time Frame
Post-treatment 8 weeks from baseline in 8 weeks intervention group
Title
Patient Health Questionnaire-9
Description
In the mindfulness-based intervention applied face-to-face and TAU group
Time Frame
Post-treatment 4 weeks from baseline in 4 weeks intervention group
Title
Patient Health Questionnaire-9
Time Frame
Six-months follow-up
Title
Patient Health Questionnaire-9
Time Frame
twelve-months follow-up
Other Pre-specified Outcome Measures:
Title
Client Service Receipt Inventory (CSRI)
Description
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.
Time Frame
Baseline
Title
Client Service Receipt Inventory (CSRI)
Description
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.
Time Frame
Six-months follow-up
Title
Client Service Receipt Inventory (CSRI)
Description
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.
Time Frame
Twelve-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Universitat Jaume I
City
Castellon de la Plana
State/Province
Valencia
ZIP/Postal Code
12071
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24497236
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.
Results Reference
background
PubMed Identifier
16516070
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. Erratum In: Gen Hosp Psychiatry. 2006 May-Jun;28(3):266.
Results Reference
background
PubMed Identifier
19192368
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.
Results Reference
background
PubMed Identifier
19045965
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.
Results Reference
background
PubMed Identifier
31619196
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.
Results Reference
derived
Links:
URL
http://www.labpsitec.uji.es
Description
Laboratory of Psychology and Technology of the University Jaume I
URL
http://www.webmindfulness.com
Description
Mental health unit in primary care.

Learn more about this trial

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

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