NCT03545074

Brief Summary

This study explores the differential efficacy of Spanish or English versions of a mindfulness intervention on Depression levels, using a pre test post test design and an active control condition (health education).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Feb 2016

Status
completed

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

February 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
Last Updated

January 15, 2019

Status Verified

January 1, 2019

Enrollment Period

1.5 years

First QC Date

May 22, 2018

Last Update Submit

January 12, 2019

Conditions

Keywords

mindfulnessdepressionSpanish

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory

    The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations

    6 weeks

Secondary Outcomes (6)

  • Five Facet Mindfulness Questionnaire

    6 weeks

  • Perceived Stress Scale

    6 weeks

  • Self Compassion Scale

    6 weeks

  • Positive and Negative Affect Schedule

    6 weeks

  • IL6

    6 weeks

  • +1 more secondary outcomes

Study Arms (4)

Mindfulness Spanish

EXPERIMENTAL

The MAPs program was developed at UCLA (Winston \& Smalley, 2010 and Lopez-Maya, 2016) and provides experiential training in mindfulness-based practices, including mindfulness meditation. UCLA-certified instructors delivered the interventions. Active program components include sitting and walking meditations, body scan and loving-kindness meditation. Participants were provided with audio CDs or digital downloads to complete their daily meditation assignments. Sessions were held once per week for 2 hours per session over a period of six consecutive weeks. Home practice assignments consist of daily mindfulness exercises starting with 5 minutes daily, progressing to 20 minutes daily by the end of the program.

Behavioral: Mindful Awareness Practices- Spanish

Mindfulness English

EXPERIMENTAL

The MAPs program was developed at UCLA (Winston \& Smalley, 2010) and provides experiential training in mindfulness-based practices, including mindfulness meditation. UCLA-certified instructors delivered the interventions. Active program components include sitting and walking meditations, body scan and loving-kindness meditation. Participants were provided with audio CDs or digital downloads to complete their daily meditation assignments. Sessions were held once per week for 2 hours per session over a period of six consecutive weeks. Home practice assignments consist of daily mindfulness exercises starting with 5 minutes daily, progressing to 20 minutes daily by the end of the program.

Behavioral: Mindful Awareness Practices- English

Health Education Spanish

ACTIVE COMPARATOR

The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general. Similar interventions have been described elsewhere (Black, et al., 2014; Irwin, et al., 2014). A trained health educator provided videos and didactic presentations on topics such as: stress, sleep hygiene, diet \& nutrition, sexuality, mental health and substance abuse. The health education condition resembled the MAPs intervention in terms of duration, group format and support, attention and participant expectancy regarding health benefits.

Behavioral: Health Education - Spanish

Health Education English

ACTIVE COMPARATOR

The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general. Similar interventions have been described elsewhere (Black, et al., 2014; Irwin, et al., 2014). A trained health educator provided videos and didactic presentations on topics such as: stress, sleep hygiene, diet \& nutrition, sexuality, mental health and substance abuse. The health education condition resembled the MAPs intervention in terms of duration, group format and support, attention and participant expectancy regarding health benefits.

Behavioral: Health Education - English

Interventions

The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in English)

Mindfulness English

The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in Spanish)

Mindfulness Spanish

The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general (in English)

Health Education English

The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general (in Spanish)

Health Education Spanish

Eligibility Criteria

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

You may qualify if:

  • In order to determine eligibility, interested participants will be phone screened. To qualify for the study, participants have to be fluent in either Spanish or English, validated by self-report at phone screening. Additionally, during the phone screening participants had to complete a 4-item version of the Perceived Stress Scale (Cohen \& Williamson, 1988) and score above the 50th percentile (a score of 9 or higher) in order to be eligible

You may not qualify if:

  • People not meeting any of the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lopez-Maya E, Olmstead R, Irwin MR. Mindfulness meditation and improvement in depressive symptoms among Spanish- and English speaking adults: A randomized, controlled, comparative efficacy trial. PLoS One. 2019 Jul 5;14(7):e0219425. doi: 10.1371/journal.pone.0219425. eCollection 2019.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pretest and immediate postest design with an active control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Fellow

Study Record Dates

First Submitted

May 22, 2018

First Posted

June 4, 2018

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

February 1, 2018

Last Updated

January 15, 2019

Record last verified: 2019-01