Clinical trial NCT02655835: Internet Mindfulness Meditation Intervention
Official title: Internet Mindfulness Meditation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Keywords: mindfulness
meditation
internet
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2016-01-14
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility 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)

Primary outcomes:
measure: Enrollment rate
timeFrame: Week 0 - Screening
measure: Participant satisfaction
timeFrame: Week 8 - Endpoint assessment
measure: Number of internet mindfulness meditation training sessions completed
timeFrame: Week 8 - Endpoint Assessment (after intervention is complete)
measure: Completion Rate
timeFrame: Week 8 - Endpoint assessment
Secondary outcomes:
measure: Quality of Life SF-36
timeFrame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
measure: Self-efficacy
timeFrame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
measure: Mood
timeFrame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
measure: Sleep
timeFrame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
measure: Mindfulness
timeFrame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
measure: Perceived Stress
timeFrame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Health and Science University
name: Barry S Oken, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.