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

A study testing Mindfulness in people with Depressive Disorder, run by Universitat Jaume I at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

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)… Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Depressive Disorder
What is being tested?: Mindfulness
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteSpain
Study dates: Oct 2016to Jun 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Spain1 site

Universitat Jaume I
Castellon, Valencia, 12071

Other trials in Spain

About this study

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

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

Read the 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.

Conditions: Depressive Disorder
Being tested: Mindfulness
Keywords: Mindfulness, Internet program, Depression, Cost-effectiveness
Medical subject headings: Depressive Disorder, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MindfulnessBehavioural

Study groups in NCT03034343
Study group	Role	What they receive
TAU+mindfulness applied face to face	Experimental	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. Receives: Behavioral: Mindfulness
TAU + Mindfulness ICTs intervention	Experimental	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. Receives: Behavioral: Mindfulness
Usual medical treatment (TAU)	No intervention	In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Beck Depression Inventory-II
Measured: Baseline
Beck Depression Inventory-II
In the mindfulness-based intervention applied by ICTs
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Beck Depression Inventory-II
In the mindfulness-based intervention applied face-to-face and TAU group
Measured: post-treatment 4 weeks from baseline in 4 weeks intervention group
Beck Depression Inventory-II
Measured: Six-months follow-up
Beck Depression Inventory-II
Measured: Twelve-months follow-up

Secondary outcomes (25)

Sociodemographic data Gender, age, marital status, education, occupation, economical level
Measured: Baseline
Health Survey 12 (SF-12)
Measured: Baseline
Health Survey 12 (SF-12)
In the mindfulness-based intervention applied by ICTs
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Health Survey 12 (SF-12)
In the mindfulness-based intervention applied face-to-face and TAU group
Measured: Post-treatment 4 weeks from baseline in 4 weeks intervention group
Health Survey 12 (SF-12)
Measured: Six-months follow-up
Health Survey 12 (SF-12)
Measured: Twelve-months follow-up
EuroQol (EQ-5D). Health related quality of life
Measured: Baseline
EuroQol (EQ-5D). Health related quality of life
Measured: Six-months follow-up
EuroQol (EQ-5D). Health related quality of life
Measured: Twelve-months follow-up
Positive and negative affect (PANAS)
Measured: Baseline
Positive and negative affect (PANAS)
In the mindfulness-based intervention applied by ICTs
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Positive and negative affect (PANAS)
In the mindfulness-based intervention applied face-to-face and TAU group
Measured: Post-treatment 4 weeks from baseline in 4 weeks intervention group
Positive and negative affect (PANAS)
Measured: Six-months follow-up
Positive and negative affect (PANAS)
Measured: Twelve-months follow-up
Five Facets and factors of mindfulness (FFMQ)
Measured: Baseline
Five Facets and factors of mindfulness (FFMQ)
Measured: Six-months follow-up
Five Facets and factors of mindfulness (FFMQ)
Measured: Twelve-months follow-up
Pemberton Happiness Index (PHI)
Measured: Baseline
Pemberton Happiness Index (PHI)
Measured: Six-months follow-up
Pemberton Happiness Index (PHI)
Measured: Twelve-months follow-up
Patient Health Questionnaire-9
Measured: Baseline
Patient Health Questionnaire-9
In the mindfulness-based intervention applied by ICTs
Measured: Post-treatment 8 weeks from baseline in 8 weeks intervention group
Patient Health Questionnaire-9
In the mindfulness-based intervention applied face-to-face and TAU group
Measured: Post-treatment 4 weeks from baseline in 4 weeks intervention group
Patient Health Questionnaire-9
Measured: Six-months follow-up
Patient Health Questionnaire-9
Measured: twelve-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Jun 2020

First posted27 Jan 2017 (estimated)
Study startOct 2016
Primary completionJun 2020 (estimated)
Study completionJun 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03034343
Sponsor's protocol ID: PI16/0202
Status last verified: Mar 2020
First submitted: 11 Jan 2017
Last updated: 31 Mar 2020
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

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.
PubMed 24497236
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.
PubMed 16516070
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.
PubMed 19192368
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.
PubMed 19045965
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.
PubMed 31619196

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03034343
Acronym / sponsor ID: PI16/0202
Conditions: Depressive Disorder
Keywords: Mindfulness, Internet program, Depression, Cost-effectiveness
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 120 participants (estimated)
Lead sponsor: Universitat Jaume IUniversity, hospital or other
Collaborators: Research Unit in Primary Care of Aragon (Spain)
Study start: Oct 2016
Primary completion: Jun 2020 (estimated)
Study completion: Jun 2020 (estimated)
First posted: 27 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
TAU+mindfulness applied face to face	Experimental	Behavioral: Mindfulness4 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.
TAU + Mindfulness ICTs intervention	Experimental	Behavioral: Mindfulness4 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.
Usual medical treatment (TAU)	No intervention	–In this group the general practitioner will apply the usual treatment (medication) but there will be no psychological treatment.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness	Behavioural	TAU + Mindfulness ICTs intervention, TAU+mindfulness applied face to face

Primary outcome

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

25 secondary outcomes

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
Health Survey 12 (SF-12)
Time frame: Post-treatment 4 weeks from baseline in 4 weeks intervention 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
Positive and negative affect (PANAS)
Time frame: Post-treatment 4 weeks from baseline in 4 weeks intervention 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
Patient Health Questionnaire-9
Time frame: Baseline
Patient Health Questionnaire-9
Time frame: 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
Patient Health Questionnaire-9
Time frame: Six-months follow-up
Patient Health Questionnaire-9
Time frame: twelve-months follow-up

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
Background: PubMed 24497236Andersson 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.
Background: PubMed 16516070Backenstrass 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.
Background: PubMed 19192368Cuijpers 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.
Background: PubMed 19045965Kuyken 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.
Derived from this study: PubMed 31619196Lopez-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.
Laboratory of Psychology and Technology of the University Jaume ILink provided by the sponsor.
Mental health unit in primary care.Link provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness in people with Depressive Disorder, run by Universitat Jaume I at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Beck Depression Inventory-II (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034343, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.