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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02655835
Other study ID # 10939
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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