Internet Mindfulness Meditation Intervention (IMMI)

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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Behavioral: Internet Mindfulness Meditation; Behavioral: Access

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet Mindfulness Meditation Intervention; Six-week internet mindfulness meditation training program including handouts and daily guided meditations	Behavioral: Internet Mindfulness Meditation
Experimental: Access; Written information handouts on mindfulness meditation and access to guided daily meditations	Behavioral: Access

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Enrollment rate	Number of participants who are eligible and enroll in the study	Week 0 - Screening
Participant satisfaction	Client Satisfaction Questionnaire	Week 8 - Endpoint assessment
Number of internet mindfulness meditation training sessions completed	There are a total of 6 internet training sessions, and participants are instructed to complete one per week (where Week 0 is screening, Week 1 is Baseline Assessment, Week 2 is Training 1, Week 3 is Training 2, Week 4 is Training 3, Week 5 is Training 4, Week 6 is Training 5, and Week 7 is Training 6) . At the time of the endpoint assessment (Week 8), the number of completed training sessions is tabulated.	Week 8 - Endpoint Assessment (after intervention is complete)
Completion Rate	Number of participants who complete the endpoint assessment.	Week 8 - Endpoint assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life SF-36	Measured with Short-Form Health Survey (SF-36) self-report measure	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Self-efficacy	Measured with General Perceived Self Efficacy (GPSE) self-report questionnaire	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mood	Measured with Center for Epidemiological Studies Depression Scale (CESD) self-report questionnaire	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Sleep	Measured with Pittsburgh Sleep Quality Index (PSQI) self-report questionnaire	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mindfulness	Measured with Five Factor Mindfulness Questionnaire (FFMQ)	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Perceived Stress	Measured with perceived stress scale (PSS)	Week 1 - Baseline assessment & Week 8 - Endpoint assessment

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Barry S Oken, MD, MS, Oregon Health and Science University

Publications and helpful links

General Publications

• Wahbeh H, Oken BS. Internet Mindfulness Meditation Intervention for the General Public: Pilot Randomized Controlled Trial. JMIR Ment Health. 2016 Aug 8;3(3):e37. doi: 10.2196/mental.5900.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 12, 2016
• First Posted (Estimate): January 14, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: mindfulness; meditation; internet
• Other Study ID Numbers: 10939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO