Internet Mindfulness Meditation Intervention (IMMI)
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|ClinicalTrials.gov Identifier: NCT02655835|
Recruitment Status : Completed
First Posted : January 14, 2016
Last Update Posted : October 29, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Stress||Behavioral: Internet Mindfulness Meditation Behavioral: Access||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Internet Mindfulness Meditation Intervention|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: Internet Mindfulness Meditation Intervention
Six-week internet mindfulness meditation training program including handouts and daily guided meditations
Behavioral: Internet Mindfulness Meditation
Written information handouts on mindfulness meditation and access to guided daily meditations
- Enrollment rate [ Time Frame: Week 0 - Screening ]Number of participants who are eligible and enroll in the study
- Participant satisfaction [ Time Frame: Week 8 - Endpoint assessment ]Client Satisfaction Questionnaire
- Number of internet mindfulness meditation training sessions completed [ Time Frame: 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.
- Completion Rate [ Time Frame: Week 8 - Endpoint assessment ]Number of participants who complete the endpoint assessment.
- Quality of Life SF-36 [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]Measured with Short-Form Health Survey (SF-36) self-report measure
- Self-efficacy [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]Measured with General Perceived Self Efficacy (GPSE) self-report questionnaire
- Mood [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]Measured with Center for Epidemiological Studies Depression Scale (CESD) self-report questionnaire
- Sleep [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]Measured with Pittsburgh Sleep Quality Index (PSQI) self-report questionnaire
- Mindfulness [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]Measured with Five Factor Mindfulness Questionnaire (FFMQ)
- Perceived Stress [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]Measured with perceived stress scale (PSS)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02655835
|Principal Investigator:||Barry S Oken, MD, MS||Oregon Health and Science University|