NCT03034343

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 31, 2020

Status Verified

March 1, 2020

Enrollment Period

3.7 years

First QC Date

January 11, 2017

Last Update Submit

March 30, 2020

Conditions

Depressive Disorder

Keywords

MindfulnessInternet programDepressionCost-effectiveness

Outcome Measures

Primary Outcomes (5)

  • Beck Depression Inventory-II

    Baseline

  • Beck Depression Inventory-II

    In the mindfulness-based intervention applied by ICTs

    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

    post-treatment 4 weeks from baseline in 4 weeks intervention group

  • Beck Depression Inventory-II

    Six-months follow-up

  • Beck Depression Inventory-II

    Twelve-months follow-up

Secondary Outcomes (25)

  • Sociodemographic data Gender, age, marital status, education, occupation, economical level

    Baseline

  • Health Survey 12 (SF-12)

    Baseline

  • Health Survey 12 (SF-12)

    Post-treatment 8 weeks from baseline in 8 weeks intervention group

  • Health Survey 12 (SF-12)

    Post-treatment 4 weeks from baseline in 4 weeks intervention group

  • Health Survey 12 (SF-12)

    Six-months follow-up

  • +20 more secondary outcomes

Other Outcomes (3)

  • Client Service Receipt Inventory (CSRI)

    Baseline

  • Client Service Receipt Inventory (CSRI)

    Six-months follow-up

  • Client Service Receipt Inventory (CSRI)

    Twelve-months follow-up

Study Arms (3)

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.

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.

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.

Interventions

MindfulnessBEHAVIORAL
TAU + Mindfulness ICTs interventionTAU+mindfulness applied face to face

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Jaume I

Castellon, Valencia, 12071, Spain

Location

Related Publications (5)

  • 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.

    PMID: 24497236BACKGROUND

  • 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.

    PMID: 16516070BACKGROUND

  • 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.

    PMID: 19192368BACKGROUND

  • 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.

    PMID: 19045965BACKGROUND

  • 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.

    PMID: 31619196DERIVED

Related Links

MeSH Terms

Conditions

Depressive DisorderDepression

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 27, 2017

Study Start

October 1, 2016

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

March 31, 2020

Record last verified: 2020-03

Locations

ES(1)