Internet Mindfulness Meditation Intervention

NCT02655835 | Completed

• 1 other identifier: 10939
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress

Keywords

mindfulness; meditation; internet

Outcome Measures

Primary Outcomes (4)

• Enrollment rate

  Number of participants who are eligible and enroll in the study

  Week 0 - Screening

• Participant satisfaction

  Client Satisfaction Questionnaire

  Week 8 - Endpoint assessment

• Number of internet mindfulness meditation training sessions completed

  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.

  Week 8 - Endpoint Assessment (after intervention is complete)

• Completion Rate

  Number of participants who complete the endpoint assessment.

  Week 8 - Endpoint assessment

Secondary Outcomes (6)

• Quality of Life SF-36

  Week 1 - Baseline assessment & Week 8 - Endpoint assessment

• Self-efficacy

  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

Study Arms (2)

Internet Mindfulness Meditation Intervention

EXPERIMENTAL

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

Behavioral: Internet Mindfulness Meditation

Access

EXPERIMENTAL

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

Behavioral: Access

Interventions

Internet Mindfulness Meditation BEHAVIORAL

Internet Mindfulness Meditation Intervention

Access BEHAVIORAL

Access

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Significant acute medical illness that would decrease likelihood of study completion (self-report)
• Significant, untreated depression, as assessed by CESD-5 \>20 during screening

Sponsors & Collaborators

• Oregon Health and Science University: lead

Related Publications (1)

• 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.

  PMID: 27502759 DERIVED

Study Officials

• Barry S Oken, MD, MS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ND, MCR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 14, 2016
• Study Start: September 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share