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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
Sponsor:
Information provided by (Responsible Party):
Helane Wahbeh, 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.


Condition or disease Intervention/treatment Phase
Stress Behavioral: Internet Mindfulness Meditation Behavioral: Access Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Internet Mindfulness Meditation Intervention
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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



Primary Outcome Measures :
  1. Enrollment rate [ Time Frame: Week 0 - Screening ]
    Number of participants who are eligible and enroll in the study

  2. Participant satisfaction [ Time Frame: Week 8 - Endpoint assessment ]
    Client Satisfaction Questionnaire

  3. 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.

  4. Completion Rate [ Time Frame: Week 8 - Endpoint assessment ]
    Number of participants who complete the endpoint assessment.


Secondary Outcome Measures :
  1. 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

  2. Self-efficacy [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]
    Measured with General Perceived Self Efficacy (GPSE) self-report questionnaire

  3. Mood [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]
    Measured with Center for Epidemiological Studies Depression Scale (CESD) self-report questionnaire

  4. Sleep [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]
    Measured with Pittsburgh Sleep Quality Index (PSQI) self-report questionnaire

  5. Mindfulness [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]
    Measured with Five Factor Mindfulness Questionnaire (FFMQ)

  6. Perceived Stress [ Time Frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment ]
    Measured with perceived stress scale (PSS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

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


Sponsors and Collaborators
Oregon Health and Science University
Investigators
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Principal Investigator: Barry S Oken, MD, MS Oregon Health and Science University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helane Wahbeh, ND, MCR, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02655835    
Other Study ID Numbers: 10939
First Posted: January 14, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Helane Wahbeh, Oregon Health and Science University:
mindfulness
meditation
internet