Internet Mindfulness Meditation Intervention

Not Applicable

Completed

• Conditions: Stress
• Interventions: Behavioral: Access; Behavioral: Internet Mindfulness Meditation

• Registration Number: NCT02655835
• Lead Sponsor: Oregon Health and Science University

Brief 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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-01-06
• Study First Submitted QC: 2016-01-12
• Study First Posted: 2016-01-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-25
• Last Update Posted: 2018-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Access	Access	Written information handouts on mindfulness meditation and access to guided daily meditations
Internet Mindfulness Meditation Intervention	Internet Mindfulness Meditation	Six-week internet mindfulness meditation training program including handouts and daily guided meditations

Primary Outcome Measures

Name	Time	Method
Completion Rate	Week 8 - Endpoint assessment	Number of participants who complete the endpoint assessment.
Enrollment rate	Week 0 - Screening	Number of participants who are eligible and enroll in the study
Participant satisfaction	Week 8 - Endpoint assessment	Client Satisfaction Questionnaire
Number of internet mindfulness meditation training sessions completed	Week 8 - Endpoint Assessment (after intervention is complete)	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.

Secondary Outcome Measures

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