Internet Mindfulness Meditation Intervention
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 52
- Primary Endpoint
- Completion Rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Internet Mindfulness Meditation Intervention
Six-week internet mindfulness meditation training program including handouts and daily guided meditations
Intervention: Internet Mindfulness Meditation (Behavioral)
Access
Written information handouts on mindfulness meditation and access to guided daily meditations
Intervention: Access (Behavioral)
Outcomes
Primary Outcomes
Completion Rate
Time Frame: Week 8 - Endpoint assessment
Number of participants who complete the endpoint assessment.
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.
Secondary Outcomes
- Quality of Life SF-36(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Mood(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Sleep(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Mindfulness(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Self-efficacy(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
- Perceived Stress(Week 1 - Baseline assessment & Week 8 - Endpoint assessment)
Investigators
Helane Wahbeh
ND, MCR
Oregon Health and Science University