Data repository for: "Randomized 1-month study to compare the efficacy of meditating with EEG-neurofeedback tool and meditation app on mental and physical health and health behaviors in university students"
Taken from the Study protocol.docx document, which describes the study approach in detail:
"Young adults in college experience high levels of stress, anxiety, and depression, which can lead to maladaptive behaviors and chronic health issues including inflammation and HPA-axis dysregulation. University mental health centers are seeking effective programs that teach coping skills to self-manage stress, with low stigma, that are easy to implement in large scale. The aim of this protocol is to describe the design of a study aiming to evaluate the effectiveness of a one-month self-guided meditation program for university students comparing various tools to improve mental health, physical health and health behaviors, and explore moderators. Secondary aims include reaching a diverse audience and documenting adverse experiences."
Population - 140 university undergraduate or postgraduate students studying at an American university.
Intervention - 10 minutes of self-guided meditation daily for four weeks, faciliated by the 10% Happier App, in combination with neurofeedback from the Muse Neurofeedback Tool.
Comparison - 10 minutes of self-guided meditation daily for four weeks, faciliated by the 10% Happier App.
Outcomes - Outcome measures included those related to Personality, Stress, Distress, Resilience (coping), Mindfulness, Emotion regulation, Sleep, Self-Regulation of Eating, Motivation Survey, and Student Adherence (for more details, see Section 2.4 of the Study protocol.docx document and the Instrument List.xlsx document).
Time - 4 week intervention followed by post-intervention surveys (1-, 6- and 12-months). See Study Timeline.xlsx for more details on the tasks performed and the data collected at each timepoint.
Study Design - randomized controlled trial with two intervention groups
All data files are available as Excel spreadsheets in the data/ subdirectory. The relationships between each data file, and between data files and other information contained in this repository, are described below:
RECAP_data.xlsx(Data dictionary:Data Dictionary for REDCAP Data.pdf) contains the raw survey data exported from the REDCAP software.External_data.xlsx(Data dictionary:Data Dictionary for External Data.xlsx) contains additional variables on each participant which were not captured by the REDCAP survey. Note some variables, such as C-Reactive protein or cortisol levels, are only available for a subset of participants, based on the availablility of saliva samples for that participant. See Section 2.2.1 inStudy protocol.docxfor more details.Combined_data.xlsxwas created by merging theRECAP_data.xlsxandExternal_data.xlsx, and is used as the complete dataset from which composite variables are created using thecreate_composite_variables.doSTATA do file. The crosswalk between the individual measures and the composite variables are described in more detail inStata Variable Crosswalk.xlsxDebriefing Interview - Wave 1.xlsx: contains qualitative reponses from "Wave 1" participants to the debriefing interview questions. Note: the interview was only done for Wave 1 participants.
In addition, we provided a work example of programmatically creating a list of keywords for this project, using the litsearchr R package. All files related to this aspect can be found in the keyword_generation subfolder.
Rebeca L. Acabchuk, University of Connecticut, Institute for Collaboration on Health, Intervention, & Policy, Department of Psychological Sciences, United States. ORCID: 0000-0001-8254-2396
This study was prospectively registered on 17 January 2018 on clinicaltrials.gov [NCT03402009].
The materials in this repository are licensed under the Creative Commons Attribution 4.0 (CC-BY-4.0) International. The full license file can be found here.