Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression

NCT ID: NCT03545074

Last Updated: 2019-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2018-02-01

Brief Summary

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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).

Detailed Description

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This study is a randomized controlled trial (RCT) with an experimental condition (MAPs Mindfulness intervention) and an active control group (Health Education), using a pretest and immediate posttest research design. Both conditions are comprised of a 6-week group intervention, which will be administered at the UCLA Westwood Medical Campus. The sample (N=80) will be drawn from a population of adults (18-65 years old), residing within a 10mile radius of the UCLA Westwood Medical Campus. To determine initial eligibility, potential participants will self-select based on perceived high levels of stress. Participants will respond self-report questionnaires to assess for psychological symptoms and will be drawn blood samples (180ml total) to assess levels of pro inflammatory cytokines before and after the interventions. Participants will attend a total of 8 visits.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pretest and immediate postest design with an active control condition.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness Spanish

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.

Group Type EXPERIMENTAL

Mindful Awareness Practices- Spanish

Intervention Type BEHAVIORAL

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

Mindfulness English

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.

Group Type EXPERIMENTAL

Mindful Awareness Practices- English

Intervention Type BEHAVIORAL

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

Health Education 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. 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.

Group Type ACTIVE_COMPARATOR

Health Education - Spanish

Intervention Type BEHAVIORAL

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 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. 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.

Group Type ACTIVE_COMPARATOR

Health Education - English

Intervention Type BEHAVIORAL

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)

Interventions

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Mindful Awareness Practices- English

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

Intervention Type BEHAVIORAL

Mindful Awareness Practices- Spanish

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

Intervention Type BEHAVIORAL

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 English)

Intervention Type BEHAVIORAL

Health Education - 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 Spanish)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* People not meeting any of the above criteria.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Eric Lopez, PhD

Postdoctoral Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 31276540 (View on PubMed)

Other Identifiers

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REMAPS

Identifier Type: -

Identifier Source: org_study_id

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