Comparison of Mindfulness Meditation Tools For College Students

NCT03402009 | Unknown

• 1 other identifier: H17-224
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine what tools best assist university students develop a personal meditation practice to self-manage stress. The two treatment conditions are 1) independent meditation using web-based tools and apps, and 2) independent meditation using web-based tools, apps and EEG-based neurofeedback. Outcomes of interest include acceptability, adherence, changes in mental health (i.e., anxiety, stress), physical health (i.e., sleep, inflammation), resilience, and level of commitment to further practice. Factors related to self-regulation (i.e., interoceptive awareness, self-esteem) will also be assessed as potential outcome moderators.

Conditions

Stress; Anxiety

Keywords

meditation; Mindfulness; stress; anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Depression, Anxiety, and Stress Scales-21

  (DASS-21; Lovibond \& Lovibond, 1995): an abbreviated, 21-item, Likert-style scale to assess levels of distress on three subscales: depression, anxiety and stress, based on how one felt over the past week. The DASS-21 has been used in prior studies assessing the benefits of mindfulness in undergraduate students (Gallego et al., 2014). It consists of 21 items with seven items per subscale, scored on a four-point scale ranging from 0 = did not apply to me at all to 3 = applied to me very much or most of the time. The total score sums all items. Higher scores indicate higher levels of distress.

  5 weeks

Secondary Outcomes (12)

• Big Five personality

  Baseline and 5 weeks

• Pittsburgh Sleep Quality Index

  Baseline and 5 weeks

• Self-Regulation of Eating Scale

  Baseline and 5 weeks

• MINDSENS (mindfulness)

  Baseline and 5 weeks

• Multidimensional Assessment of Interoceptive Awareness (MAIA)

  Baseline and 5 weeks

Other Outcomes (2)

• Long-term Follow-up Survey

  1, 6, and 12 months following completion of the satisfaction follow-up

• Satisfaction with Mindfulness Tools

  5 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

independent meditation using web-based tools, apps, and EEG neurofeedback

Behavioral: Apps; Behavioral: EEG neurofeedback

Active Control

ACTIVE COMPARATOR

independent meditation using web-based tools and apps

Behavioral: Apps

Interventions

Apps BEHAVIORAL

Apps and weblinks to coach self-guided meditation.

Active Control; Experimental

EEG neurofeedback BEHAVIORAL

Device provides feedback based on EEG readings.

Experimental

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• English literate, undergraduates and graduate students attending UConn ages 18 and above (unless they are registered with the participant pool), who agree with the initial terms, are willing to learn basic skills of mindfulness meditation, agree to practice meditating with assigned tools independently and feel able to adhere to the time commitment required for the study. Participants must not currently have a regular seated meditation practice (regular, meaning at least 1x per week).

You may not qualify if:

• participants unable to adhere to the commitment required for the study will be excluded

Sponsors & Collaborators

• University of Connecticut: lead

Study Sites (1)

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Amyloid Precursor Protein Secretases

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Blair T. Johnson, PhD

  University of Connecticut - BOT Distinguished Professor of Psychological Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BoT Distinguished Professor of Psychological Sciences

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: January 17, 2018
• Study Start: March 5, 2018
• Primary Completion: December 5, 2018
• Study Completion: December 31, 2019
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available after results have been published.
• Access Criteria: Data access requests will be reviewed and requestors will be required to sign a Data Access Agreement

Locations

US (1)