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"

Study description

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."

PICOTS

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

Data source files

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 in Study protocol.docx for more details.
• Combined_data.xlsx was created by merging the RECAP_data.xlsx and External_data.xlsx, and is used as the complete dataset from which composite variables are created using the create_composite_variables.do STATA do file. The crosswalk between the individual measures and the composite variables are described in more detail in Stata Variable Crosswalk.xlsx
• Debriefing 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.

Permanent contact about this data

Rebeca L. Acabchuk, University of Connecticut, Institute for Collaboration on Health, Intervention, & Policy, Department of Psychological Sciences, United States. ORCID: 0000-0001-8254-2396

Registration

This study was prospectively registered on 17 January 2018 on clinicaltrials.gov [NCT03402009].

Licence

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.