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

Status

Unknown

Conditions

Intervention / Treatment

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

    • Valencia
      • Castellon de la Plana, Valencia, Spain, 12071
        • Universitat Jaume I

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory-II
Time Frame: Baseline
Baseline
Beck Depression Inventory-II
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
Beck Depression Inventory-II
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
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
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
Health Survey 12 (SF-12)
Time Frame: Twelve-months follow-up
Twelve-months follow-up
EuroQol (EQ-5D). Health related quality of life
Time Frame: Baseline
Baseline
EuroQol (EQ-5D). Health related quality of life
Time Frame: Six-months follow-up
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.

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.

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

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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