Internet Mindfulness Meditation Intervention

Stress Clinical Trial

— IMMI  

Official title:

Internet Mindfulness Meditation Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655835
• Other study ID #: 10939
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2018
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Internet Mindfulness Meditation

• Access

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	Number of participants who are eligible and enroll in the study	Week 0 - Screening
Primary	Participant satisfaction	Client Satisfaction Questionnaire	Week 8 - Endpoint assessment
Primary	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)
Primary	Completion Rate	Number of participants who complete the endpoint assessment.	Week 8 - Endpoint assessment
Secondary	Quality of Life SF-36	Measured with Short-Form Health Survey (SF-36) self-report measure	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Secondary	Self-efficacy	Measured with General Perceived Self Efficacy (GPSE) self-report questionnaire	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Secondary	Mood	Measured with Center for Epidemiological Studies Depression Scale (CESD) self-report questionnaire	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Secondary	Sleep	Measured with Pittsburgh Sleep Quality Index (PSQI) self-report questionnaire	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Secondary	Mindfulness	Measured with Five Factor Mindfulness Questionnaire (FFMQ)	Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Secondary	Perceived Stress	Measured with perceived stress scale (PSS)	Week 1 - Baseline assessment & Week 8 - Endpoint assessment