NCT04589195

Brief Summary

The purpose of the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
12 months until next milestone

Study Start

First participant enrolled

October 11, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2021

Completed
Last Updated

January 14, 2022

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

October 9, 2020

Last Update Submit

January 12, 2022

Conditions

Keywords

Mindfulness TrainingCognitive TrainingPsychological Health

Outcome Measures

Primary Outcomes (3)

  • Change in Positive Affect

    Positive affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS positive sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher positive mood.

    Baseline to Week 5

  • Change in Negative Affect

    Negative affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS negative sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher negative mood.

    Baseline to Week 5

  • Change in Perceived Stress

    Perceived Stress will be measured with the Perceived Stress Scale (PSS). PSS has a range of scores from 0 to 40, with a higher score indicates a higher level of perceived stress.

    Baseline to Week 5

Secondary Outcomes (2)

  • Change in Sustained Attention Response Task (SART) scores

    Baseline to Week 5

  • Change in Cognitive Failures

    Baseline to Week 5

Other Outcomes (3)

  • Change in Psychological Health

    Baseline to Week 5

  • Change in Mindfulness

    Baseline to Week 5

  • Change in Decentering

    Baseline to Week 5

Study Arms (2)

Mindfulness Training (MT) Group

EXPERIMENTAL

Participants will receive four weeks of MT.

Behavioral: Mindfulness Training

Wait List MT Group

ACTIVE COMPARATOR

Participants will receive four weeks of MT training after a five week washout period.

Behavioral: Mindfulness Training

Interventions

The intervention includes four weeks of MT application use, accessed via phone or computer, consisting of 15-minute daily mindfulness practices 5 days a week.

Mindfulness Training (MT) GroupWait List MT Group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals who are between 18 and 64 years of age.
  • Individuals who are fluent English speakers.
  • Individuals who have access to either an Apple or Android smart phone and a desktop or laptop computer, are able to adequately and independently use both devices, and have Internet connection.
  • Individuals who are willing and able to consent to participate in the study.
  • Individuals who are in the South Florida ROTC program.

You may not qualify if:

  • Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Amishi Jha, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

October 11, 2021

Primary Completion

November 29, 2021

Study Completion

December 26, 2021

Last Updated

January 14, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations