Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression (REMAPS)

Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression: A Randomized Controlled Trial in Spanish or English Speaking Cohorts

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).

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Mindful Awareness Practices- Spanish; Behavioral: Mindful Awareness Practices- English; Behavioral: Health Education - Spanish; Behavioral: Health Education - English

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Mindful Awareness Practices- Spanish; The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in Spanish)
Experimental: 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.	Behavioral: Mindful Awareness Practices- English; The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in English)
Active Comparator: 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.	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)
Active Comparator: 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five Facet Mindfulness Questionnaire	This instrument is based on a factor analytic study of five independently developed mindfulness questionnaires. The analysis yielded five factors that appear to represent elements of mindfulness as it is currently conceptualized. The five facets are observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience.	6 weeks
Perceived Stress Scale	The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. Higher scores represent overall higher levels of perceived stress. Scores range from 0 to 40 points.	6 weeks
Self Compassion Scale	The Self-Compassion Scale is a psychometrically sound and theoretically valid measure of self-compassion. Scores range from 26 to 130, with higher scores representing higher levels of self-compassion. All subscales (Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness and Over-identified) are combined to compute a total score.	6 weeks
Positive and Negative Affect Schedule	he Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire that consists of two 10-item scales to measure both positive and negative affect. Scores range from 10 to 50 points, with higher scores representing higher levels of positive or negative affect.	6 weeks
IL6	Plasma concentrations of Interleukin-6	6 weeks
TNFa	Plasma concentrations of tumor necrosis factor alpha	6 weeks

Collaborators and Investigators

• Sponsor: University of California, Los Angeles

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: May 22, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 12, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: depression; mindfulness; Spanish
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: REMAPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No