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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindful Awareness Practices- English
Mindful Awareness Practices- Spanish
Health Education - English
Health Education - Spanish
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring mindfulness, depression, Spanish

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Mindfulness Spanish

    Mindfulness English

    Health Education Spanish

    Health Education English

    Arm Description

    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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    IL6
    Plasma concentrations of Interleukin-6
    TNFa
    Plasma concentrations of tumor necrosis factor alpha

    Full Information

    First Posted
    May 22, 2018
    Last Updated
    January 12, 2019
    Sponsor
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03545074
    Brief Title
    Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression
    Acronym
    REMAPS
    Official Title
    Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression: A Randomized Controlled Trial in Spanish or English Speaking Cohorts
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    August 1, 2017 (Actual)
    Study Completion Date
    February 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of California, Los Angeles

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    mindfulness, depression, Spanish

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Pretest and immediate postest design with an active control condition.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    76 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness Spanish
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Mindfulness English
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Health Education Spanish
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Health Education English
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindful Awareness Practices- English
    Intervention Description
    The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in English)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindful Awareness Practices- Spanish
    Intervention Description
    The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in Spanish)
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health Education - English
    Intervention Description
    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
    Intervention Name(s)
    Health Education - Spanish
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    Beck Depression Inventory
    Description
    The Beck Depression Inventory (BDI) is a 21-item self-reporting questionnaire for evaluating the severity of depression in normal and psychiatric populations
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Five Facet Mindfulness Questionnaire
    Description
    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.
    Time Frame
    6 weeks
    Title
    Perceived Stress Scale
    Description
    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.
    Time Frame
    6 weeks
    Title
    Self Compassion Scale
    Description
    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.
    Time Frame
    6 weeks
    Title
    Positive and Negative Affect Schedule
    Description
    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.
    Time Frame
    6 weeks
    Title
    IL6
    Description
    Plasma concentrations of Interleukin-6
    Time Frame
    6 weeks
    Title
    TNFa
    Description
    Plasma concentrations of tumor necrosis factor alpha
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    31276540
    Citation
    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.
    Results Reference
    derived

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

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