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

Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03034343
• Other study ID #: PI16/0202
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Est. completion date: June 2020

Study information

• Verified date: March 2020
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Mindfulness

Locations

Country	Name	City	State
Spain	Universitat Jaume I	Castellon de la Plana	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Jaume I	Research Unit in Primary Care of Aragon (Spain)

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. — View Citation

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Client Service Receipt Inventory (CSRI)	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
Other	Client Service Receipt Inventory (CSRI)	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
Other	Client Service Receipt Inventory (CSRI)	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
Primary	Beck Depression Inventory-II		Baseline
Primary	Beck Depression Inventory-II	In the mindfulness-based intervention applied by ICTs	Post-treatment 8 weeks from baseline in 8 weeks intervention group
Primary	Beck Depression Inventory-II	In the mindfulness-based intervention applied face-to-face and TAU group	post-treatment 4 weeks from baseline in 4 weeks intervention group
Primary	Beck Depression Inventory-II		Six-months follow-up
Primary	Beck Depression Inventory-II		Twelve-months follow-up
Secondary	Sociodemographic data Gender, age, marital status, education, occupation, economical level		Baseline
Secondary	Health Survey 12 (SF-12)		Baseline
Secondary	Health Survey 12 (SF-12)	In the mindfulness-based intervention applied by ICTs	Post-treatment 8 weeks from baseline in 8 weeks intervention group
Secondary	Health Survey 12 (SF-12)	In the mindfulness-based intervention applied face-to-face and TAU group	Post-treatment 4 weeks from baseline in 4 weeks intervention group
Secondary	Health Survey 12 (SF-12)		Six-months follow-up
Secondary	Health Survey 12 (SF-12)		Twelve-months follow-up
Secondary	EuroQol (EQ-5D). Health related quality of life		Baseline
Secondary	EuroQol (EQ-5D). Health related quality of life		Six-months follow-up
Secondary	EuroQol (EQ-5D). Health related quality of life		Twelve-months follow-up
Secondary	Positive and negative affect (PANAS)		Baseline
Secondary	Positive and negative affect (PANAS)	In the mindfulness-based intervention applied by ICTs	Post-treatment 8 weeks from baseline in 8 weeks intervention group
Secondary	Positive and negative affect (PANAS)	In the mindfulness-based intervention applied face-to-face and TAU group	Post-treatment 4 weeks from baseline in 4 weeks intervention group
Secondary	Positive and negative affect (PANAS)		Six-months follow-up
Secondary	Positive and negative affect (PANAS)		Twelve-months follow-up
Secondary	Five Facets and factors of mindfulness (FFMQ)		Baseline
Secondary	Five Facets and factors of mindfulness (FFMQ)		Six-months follow-up
Secondary	Five Facets and factors of mindfulness (FFMQ)		Twelve-months follow-up
Secondary	Pemberton Happiness Index (PHI)		Baseline
Secondary	Pemberton Happiness Index (PHI)		Six-months follow-up
Secondary	Pemberton Happiness Index (PHI)		Twelve-months follow-up
Secondary	Patient Health Questionnaire-9		Baseline
Secondary	Patient Health Questionnaire-9	In the mindfulness-based intervention applied by ICTs	Post-treatment 8 weeks from baseline in 8 weeks intervention group
Secondary	Patient Health Questionnaire-9	In the mindfulness-based intervention applied face-to-face and TAU group	Post-treatment 4 weeks from baseline in 4 weeks intervention group
Secondary	Patient Health Questionnaire-9		Six-months follow-up
Secondary	Patient Health Questionnaire-9		twelve-months follow-up

External Links

•   Laboratory of Psychology and Technology of the University Jaume I
•   Mental health unit in primary care.