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

• ClinicalTrials.gov Identifier: NCT03034343
• Recruitment Status: Unknown
• First Posted: January 27, 2017
• Last Update Posted: March 31, 2020
• Sponsor: Universitat Jaume I
• Collaborator: Research Unit in Primary Care of Aragon (Spain)
• Information provided by (Responsible Party): Universitat Jaume I

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

Condition or disease	Intervention/treatment	Phase
Depressive Disorder	Behavioral: Mindfulness	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (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
• Study Start Date: October 2016
• Estimated Primary Completion Date: June 2020
• Estimated Study Completion Date: June 2020

Arms and Interventions

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.	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.

Outcome Measures

Primary Outcome Measures :

1. Beck Depression Inventory-II [ Time Frame: Baseline ]
2. 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
3. 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
4. Beck Depression Inventory-II [ Time Frame: Six-months follow-up ]
5. Beck Depression Inventory-II [ Time Frame: Twelve-months follow-up ]

Secondary Outcome Measures :

1. Sociodemographic data Gender, age, marital status, education, occupation, economical level [ Time Frame: Baseline ]
2. Health Survey 12 (SF-12) [ Time Frame: Baseline ]
3. 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
4. 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
5. Health Survey 12 (SF-12) [ Time Frame: Six-months follow-up ]
6. Health Survey 12 (SF-12) [ Time Frame: Twelve-months follow-up ]
7. EuroQol (EQ-5D). Health related quality of life [ Time Frame: Baseline ]
8. EuroQol (EQ-5D). Health related quality of life [ Time Frame: Six-months follow-up ]
9. EuroQol (EQ-5D). Health related quality of life [ Time Frame: Twelve-months follow-up ]
10. Positive and negative affect (PANAS) [ Time Frame: Baseline ]
11. 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
12. 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
13. Positive and negative affect (PANAS) [ Time Frame: Six-months follow-up ]
14. Positive and negative affect (PANAS) [ Time Frame: Twelve-months follow-up ]
15. Five Facets and factors of mindfulness (FFMQ) [ Time Frame: Baseline ]
16. Five Facets and factors of mindfulness (FFMQ) [ Time Frame: Six-months follow-up ]
17. Five Facets and factors of mindfulness (FFMQ) [ Time Frame: Twelve-months follow-up ]
18. Pemberton Happiness Index (PHI) [ Time Frame: Baseline ]
19. Pemberton Happiness Index (PHI) [ Time Frame: Six-months follow-up ]
20. Pemberton Happiness Index (PHI) [ Time Frame: Twelve-months follow-up ]
21. Patient Health Questionnaire-9 [ Time Frame: Baseline ]
22. 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
23. 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
24. Patient Health Questionnaire-9 [ Time Frame: Six-months follow-up ]
25. Patient Health Questionnaire-9 [ Time Frame: twelve-months follow-up ]

Other Outcome Measures:

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• 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

Locations

Spain

Universitat Jaume I

Castellon de la Plana, Valencia, Spain, 12071

Sponsors and Collaborators

Universitat Jaume I

Research Unit in Primary Care of Aragon (Spain)

More Information

Additional Information:

Laboratory of Psychology and Technology of the University Jaume I 

Mental health unit in primary care. 

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.

Backenstrass M, Joest K, Frank A, Hingmann S, Mundt C, Kronmüller 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. 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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Universitat Jaume I
• ClinicalTrials.gov Identifier: NCT03034343
• Other Study ID Numbers: PI16/0202
• First Posted: January 27, 2017
• Last Update Posted: March 31, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Universitat Jaume I:

Mindfulness; Internet program; Depression; Cost-effectiveness

Additional relevant MeSH terms:

Depression; Depressive Disorder; Behavioral Symptoms; Mood Disorders; Mental Disorders