Overview

This trial is active, not recruiting.

Condition stress
Treatments internet mindfulness meditation, access
Sponsor Oregon Health and Science University
Start date September 2014
End date December 2015
Trial size 52 participants
Trial identifier NCT02655835, 10939

Summary

Phase 1 will follow 40 subjects and hopes to address whether or not IMMI can increase meditation practice as compared to another meditation program. The study will last six weeks for both the IMMI group (20 subjects) and the Access group (20 subjects). Access groups will receive learning materials and guided meditations, but the implementation will be self-paced. Participants in the IMMI group will receive weekly learning sessions and be required to practice meditation every day. IMMI group participants will also receive a weekly reminder call from a member of the study staff and have access to technical support in the event of trouble with the online program. All subjects will complete online self-report questionnaires that measure quality of life, self-efficacy, mood, sleep, mindfulness, and perceived stress at baseline and at the end of the six-week intervention. Subjects will also be given a questionnaire at the end of the study gauging their satisfaction with the mindfulness program they participated in.

Phase 2 will follow 80 subjects and hopes to address whether or not IMMI is acceptable to participants and demographic information about IMMI users. The study will be the same as noted above, but all subjects will be entered in the IMMI program.

Differences in recruitment rates, drop out, and patient satisfaction between the IMMI and Access groups will be analyzed. IMMI's ability to change meditation behavior (i.e. increasing time or frequency of meditation sessions), and improve quality of life will be examined as well.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (investigator)
Arm
(Experimental)
Six-week internet mindfulness meditation training program including handouts and daily guided meditations
internet mindfulness meditation
(Experimental)
Written information handouts on mindfulness meditation and access to guided daily meditations
access

Primary Outcomes

Measure
Enrollment rate
time frame: Week 0 - Screening
Participant satisfaction
time frame: Week 8 - Endpoint assessment
Number of internet mindfulness meditation training sessions completed
time frame: Week 8 - Endpoint Assessment (after intervention is complete)
Completion Rate
time frame: Week 8 - Endpoint assessment

Secondary Outcomes

Measure
Quality of Life
time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Self-efficacy
time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mood
time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Sleep
time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mindfulness
time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Perceived Stress
time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Age 18 - 80 years old - Access to Computer and Internet - Can hear and understand instructions - Willing to accept randomization scheme and agrees to follow the study protocol Exclusion Criteria: - Significant acute medical illness that would decrease likelihood of study completion (self-report) - Significant, untreated depression, as assessed by CESD-5 >20 during screening - Current daily meditation practice (≥ 5 min/day daily for at least 30 days in the last 6 months. Past practice not exclusionary but will be recorded)

Additional Information

Official title Internet Mindfulness Meditation Intervention
Principal investigator Barry S Oken, MD, MS
Description Participants will undergo the following: Week 0 - Telephone screening; Week 1 - Baseline Assessment; Week 2-Week 7 - Internet Mindfulness Meditation Intervention (or Access in Phase 1); Week 8 - Endpoint Assessment
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Oregon Health and Science University.