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

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ClinicalTrials.gov Identifier: NCT03545074
Recruitment Status : Completed
First Posted : June 4, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Lopez, PhD, University of California, Los Angeles

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).

Condition or disease Intervention/treatment Phase
Depression Behavioral: Mindful Awareness Practices- English Behavioral: Mindful Awareness Practices- Spanish Behavioral: Health Education - English Behavioral: Health Education - Spanish Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pretest and immediate postest design with an active control condition.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression: A Randomized Controlled Trial in Spanish or English Speaking Cohorts
Actual Study Start Date : February 1, 2016
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. Beck Depression Inventory [ Time Frame: 6 weeks ]
    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 :
  1. Five Facet Mindfulness Questionnaire [ Time Frame: 6 weeks ]
    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.

  2. Perceived Stress Scale [ Time Frame: 6 weeks ]
    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.

  3. Self Compassion Scale [ Time Frame: 6 weeks ]
    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.

  4. Positive and Negative Affect Schedule [ Time Frame: 6 weeks ]
    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.

  5. IL6 [ Time Frame: 6 weeks ]
    Plasma concentrations of Interleukin-6

  6. TNFa [ Time Frame: 6 weeks ]
    Plasma concentrations of tumor necrosis factor alpha



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric Lopez, PhD, Postdoctoral Fellow, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03545074     History of Changes
Other Study ID Numbers: REMAPS
First Posted: June 4, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric Lopez, PhD, University of California, Los Angeles:
mindfulness
depression
Spanish
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders