Internet Mindfulness Meditation Intervention

NCT ID: NCT02655835

Last Updated: 2018-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-12-31

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

Conditions

Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Internet Mindfulness Meditation Intervention

Six-week internet mindfulness meditation training program including handouts and daily guided meditations

Group Type: EXPERIMENTAL

Internet Mindfulness Meditation

Intervention Type: BEHAVIORAL

Access

Written information handouts on mindfulness meditation and access to guided daily meditations

Group Type: EXPERIMENTAL

Access

Intervention Type: BEHAVIORAL

Interventions

Internet Mindfulness Meditation

Intervention Type: BEHAVIORAL

Access

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Helane Wahbeh

ND, MCR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barry S Oken, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

References

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.

Reference Type: DERIVED

PMID: 27502759 (View on PubMed)

Other Identifiers

10939

Identifier Type: -

Identifier Source: org_study_id