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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

Tracking Information
First Submitted Date  ICMJE January 6, 2016
First Posted Date  ICMJE January 14, 2016
Last Update Posted Date October 29, 2018
Study Start Date  ICMJE September 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2016)
  • Quality of Life [ 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Internet Mindfulness Meditation Intervention
Official Title  ICMJE Internet Mindfulness Meditation Intervention
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Condition  ICMJE Stress
Intervention  ICMJE
  • Behavioral: Internet Mindfulness Meditation
  • Behavioral: Access
Study Arms  ICMJE
  • Experimental: Internet Mindfulness Meditation Intervention
    Six-week internet mindfulness meditation training program including handouts and daily guided meditations
    Intervention: Behavioral: Internet Mindfulness Meditation
  • Experimental: Access
    Written information handouts on mindfulness meditation and access to guided daily meditations
    Intervention: Behavioral: Access
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2016)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02655835
Other Study ID Numbers  ICMJE 10939
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Helane Wahbeh, Oregon Health and Science University
Study Sponsor  ICMJE Oregon Health and Science University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barry S Oken, MD, MS Oregon Health and Science University
PRS Account Oregon Health and Science University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP