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OpenTrials
Completed

NCT Number: NCT02655835

Internet Mindfulness Meditation Intervention

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.

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Key information

Conditions

Stress

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Internet Mindfulness Meditation

Behavioral

ACCESS

Behavioral

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Acronym: IMMI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 14, 2016
Registry last updated
Oct 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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