Clinical trial NCT03545074: Efficacy of Spanish or English Language Versions of Mindfulness Meditation on Depression
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
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: mindfulness
depression
Spanish
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pretest and immediate postest design with an active control condition.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Beck Depression Inventory
timeFrame: 6 weeks
Secondary outcomes:
measure: Five Facet Mindfulness Questionnaire
timeFrame: 6 weeks
measure: Perceived Stress Scale
timeFrame: 6 weeks
measure: Self Compassion Scale
timeFrame: 6 weeks
measure: Positive and Negative Affect Schedule
timeFrame: 6 weeks
measure: IL6
timeFrame: 6 weeks
measure: TNFa
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References:
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.