This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Soledad Quero, Universitat Jaume I
Sponsor:
Collaborator:
Research Unit in Primary Care of Aragon (Spain)
Information provided by (Responsible Party):
Soledad Quero, Universitat Jaume I
ClinicalTrials.gov Identifier:
NCT03034343
First received: January 11, 2017
Last updated: January 24, 2017
Last verified: January 2017
  Purpose
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

Condition Intervention
Depressive Disorder Behavioral: Mindfulness

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Further study details as provided by Soledad Quero, Universitat Jaume I:

Primary Outcome Measures:
  • Beck Depression Inventory-II [ Time Frame: 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

  • 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

  • Beck Depression Inventory-II [ Time Frame: Six-months follow-up ]
  • Beck Depression Inventory-II [ Time Frame: Twelve-months follow-up ]
  • Patient Health Questionnaire-9 [ Time Frame: 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

  • 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

  • Patient Health Questionnaire-9 [ Time Frame: Six-months follow-up ]
  • Patient Health Questionnaire-9 [ Time Frame: twelve-months follow-up ]

Secondary Outcome Measures:
  • Sociodemographic data Gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
  • Health Survey 12 (SF-12) [ Time Frame: 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

  • 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

  • Health Survey 12 (SF-12) [ Time Frame: Six-months follow-up ]
  • Health Survey 12 (SF-12) [ Time Frame: Twelve-months follow-up ]
  • EuroQol (EQ-5D). Health related quality of life [ Time Frame: Baseline ]
  • EuroQol (EQ-5D). Health related quality of life [ Time Frame: Six-months follow-up ]
  • EuroQol (EQ-5D). Health related quality of life [ Time Frame: Twelve-months follow-up ]
  • Positive and negative affect (PANAS) [ Time Frame: 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

  • 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

  • Positive and negative affect (PANAS) [ Time Frame: Six-months follow-up ]
  • Positive and negative affect (PANAS) [ Time Frame: Twelve-months follow-up ]
  • Five Facets and factors of mindfulness (FFMQ) [ Time Frame: Baseline ]
  • Five Facets and factors of mindfulness (FFMQ) [ Time Frame: Six-months follow-up ]
  • Five Facets and factors of mindfulness (FFMQ) [ Time Frame: Twelve-months follow-up ]
  • Pemberton Happiness Index (PHI) [ Time Frame: Baseline ]
  • Pemberton Happiness Index (PHI) [ Time Frame: Six-months follow-up ]
  • Pemberton Happiness Index (PHI) [ Time Frame: Twelve-months follow-up ]

Estimated Enrollment: 120
Study Start Date: October 2016
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Mindfulness
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.
Behavioral: Mindfulness
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.

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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03034343

Contacts
Contact: Soledad Quero, PhD 964 72 77 26 ext 7726 squero@psb.uji.es

Locations
Spain
Universitat Jaume I Recruiting
Castellon de la Plana, Valencia, Spain, 12071
Contact: Soledad Quero, PhD    964 72 77 26 ext 7726    squero@psb.uji.es   
Sub-Investigator: Javier García-Campayo, PhD         
Sponsors and Collaborators
Universitat Jaume I
Research Unit in Primary Care of Aragon (Spain)
  More Information

Additional Information:
Publications:
Responsible Party: Soledad Quero, PhD Professor of Clinical Psychology. Vice-Dean of Masters at Faculty of Health Sciences, Universitat Jaume I
ClinicalTrials.gov Identifier: NCT03034343     History of Changes
Other Study ID Numbers: PI16/0202
Study First Received: January 11, 2017
Last Updated: January 24, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Soledad Quero, Universitat Jaume I:
Mindfulness
Internet program
Depression
Cost-effectiveness

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 23, 2017