Optimizing Daily Mindfulness Interventions Using Peer Support to Increase Well-Being in First-Year Students

March 31, 2021 updated by: Marcus Rodriguez, Pitzer College
This project aims to examine the effect of a self-guided, evidence-based, online mindfulness intervention on well-being among first-year undergraduates at the 5 Claremont Colleges (5C's) and graduate students in the community. Additionally, it explores the feasibility and efficacy of peer support (pairs) as an adjunctive treatment component to enhance engagement and treatment effects, including social-connectedness, well- being, academic outcomes, and anxiety. Findings will provide insight into effective ways to (1) support students at The Claremont Colleges, and (2) leverage technology and peer support to implement mental health initiatives that are cost-effective, easily transportable, and scalable in low-resource settings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Claremont, California, United States, 91711
        • Recruiting
        • Claremont Graduate University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all participants must be either a first-year undergraduate student or a graduate student. Participants must be 18 years or older.

Exclusion Criteria:

  • all participants must be either a first-year undergraduate student or a graduate student. Participants must be 18 years or older.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online Mindfulness Intervention (OMI)
Before beginning the daily practices, this group will be introduced to the OMI via an online platform and answer any questions about the practice. Then, each day, this group will be guided through a series of mindfulness practices offered online (www.bemindfulonline.com) delivered on their smartphones or laptops.
Behavioral: Benign Behavioral Interventions
This project will use a Randomized Control Trial (RCT) design and Daily Reconstruction Method (DRM8) to model the effects of the OMI on dynamic changes in first-year undergraduate and graduate students' well-being over time. The intervention will take place over the course of 46 days, with a 7- day follow up assessment taking place one month after the intervention. People will complete surveys through an online link leading to Qualtrics.com.
Experimental: OMI paired with peer support (OMI+)
Before beginning the daily OMI, in addition to being briefed, this group will be paired with a peer to be in touch with and guide and support each other in this process. Then they will start the OMI program and will follow parallel instructions as the OMI group. The peer support will include five brief (30-minute) weekly meetings to support and encourage each other to continue practicing mindfulness and to complete the online intervention. Each week we will provide prompts and topics for participants to discuss and at the end of each meeting, participants will then complete a short, 5-10 minute post-meeting survey to assess the well-being and attitudes of their partner (see additional materials for meeting prompts and post-meeting survey questions). The first of these meetings will occur on Day 8, and subsequent weekly meetings during the intervention period will be scheduled based on the shared availability of both participants in each pair.
Behavioral: Benign Behavioral Interventions
This project will use a Randomized Control Trial (RCT) design and Daily Reconstruction Method (DRM8) to model the effects of the OMI on dynamic changes in first-year undergraduate and graduate students' well-being over time. The intervention will take place over the course of 46 days, with a 7- day follow up assessment taking place one month after the intervention. People will complete surveys through an online link leading to Qualtrics.com.
Active Comparator: Active control receiving cognitive exercises
Instead of the OMI, this group will be receiving cognitive exercises in the intervention period.
Behavioral: Benign Behavioral Interventions
This project will use a Randomized Control Trial (RCT) design and Daily Reconstruction Method (DRM8) to model the effects of the OMI on dynamic changes in first-year undergraduate and graduate students' well-being over time. The intervention will take place over the course of 46 days, with a 7- day follow up assessment taking place one month after the intervention. People will complete surveys through an online link leading to Qualtrics.com.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Baseline to Day 46

The FFMQ is a self-reported, instrument assessing mindfulness based on five factors that represent elements of mindfulness ( observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience). Possible scores range from 1 (never or very rarely true) to 5 (very often or always true).

Reference: Bohlmeijer, E., P. M. ten Klooster, et al. (2011). "Psychometric properties of the five facet mindfulness questionnaire in depressed adults and development of a short form." Assessment 18(3): 308-320
Baseline to Day 46

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sample Attrition
Time Frame: Baseline to Day 46
Completion rate or drop out rate comparing OMI group versus OMI+ group in a 46 day longitudinal study.
Baseline to Day 46
PERMA (Overall Well Being)
Time Frame: Day 0-46

The self-reported measure consists of 23 items. The health, negative emotion, loneliness, and overall happiness questions act as filler questions and provide more information; for briefness, the 15 PERMA questions (3 per PERMA domain) could be used, but we recommend using the full measure.

Reference: Butler, J., & Kern, M. L. (2016). The PERMA-Profiler: A brief multidimensional measure of flourishing. International Journal of Wellbeing, 6(3), 1-48. doi:10.5502/ijw.v6i3.1
Day 0-46

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Report Health (SF-36)
Time Frame: Baseline

SF-36 is a self-reported instrument assessing easily administered quality-of-life measures which consists of 8 subscales. These measures rely upon patient self-reporting and are now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients.

Reference: Ware, IE. Jr., Snow, K.K, Kosinski, M., & Gandek, B. (1993). SF-36 Health Survey. Manual and Interpretation Guide. Boston, MA: Nimrod Press.
Baseline
Academic Motivation Scale
Time Frame: Day 38

The Academic Motivation Scale (AMS) is a validated, self-reported, seven point Likert type item scale that measures Intrinsic, extrinsic, and Amotivation in education. Possible scores range from 1 (does not correspond at all) to 7 (corresponds exactly).

Reference: Vallerand, R. J., Pelletier, L. G., Blais, M. R., Brière, N. M., Senécal, C. B., & Vallières, É. F. (1993). Academic motivation scale (ams-c 28) college (cegep) version. Educ Psychol Meas, 52, 1003-17.
Day 38

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pitzer College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 3, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 3661

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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