Recruiting

Mindfulness Interventions

Sponsor:

Pitzer College

Code:

NCT04828291

Conditions

OMI, OMI+, Control Group

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Benign Behavioral Interventions

Study Details

Brief summary:

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.

Conditions

OMI, OMI+, Control Group

Study ID

NCT04828291

Start date

Feb 3, 2020

Status verified date

Mar, 2021

Completion date

May 31, 2021

Anticipated

Primary completion date

Aug 31, 2020

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

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 Design

Enrollment

180 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

active comparator: Active control receiving cognitive exercises

Instead of the OMI, this group will be receiving cognitive exercises in the intervention period.

Interventions

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.

Primary outcome measure

  • Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline to Day 46 ]

Central Contacts and Locations

Central contacts

Jaymes Paolo Rombaoa, PhD candidate

(714) 231-7461jaymes.paolo-rombaoa@cgu.edu

Marcus Rodriguez, PhD

Marcus_Rodriguez@pitzer.edu

Locations

Claremont Graduate University

Recruiting

Claremont, California, United States, 91711

Contacts

Saida Heshmati, PhD

424-386-2416saida.heshmati@cgu.edu

More Information

Sponsor

Pitzer College

Last update posted

Apr 2, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Pitzer College on 2021-04-02.