StressIMMINCT02655835
Internet Mindfulness Meditation Intervention
A study testing Internet Mindfulness Meditation and Access in people with Stress, run by Oregon Health and Science University.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Internet Mindfulness Meditation and Access
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
About this study
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.
Read the 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
- Being tested
- Internet Mindfulness Meditation, Access
- Keywords
- mindfulness, meditation, internet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Mindfulness MeditationBehavioural
AccessBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Internet Mindfulness Meditation Intervention | Experimental | Six-week internet mindfulness meditation training program including handouts and daily guided meditations Receives: Behavioral: Internet Mindfulness Meditation |
| Access | Experimental | Written information handouts on mindfulness meditation and access to guided daily meditations Receives: Behavioral: Access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Number of participants who are eligible and enroll in the study
Measured: Week 0 - Screening
Participant satisfaction
Client Satisfaction Questionnaire
Measured: 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.
Measured: Week 8 - Endpoint Assessment (after intervention is complete)
Completion Rate
Number of participants who complete the endpoint assessment.
Measured: Week 8 - Endpoint assessment
Secondary outcomes (6)
Quality of Life SF-36
Measured with Short-Form Health Survey (SF-36) self-report measure
Measured: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Self-efficacy
Measured with General Perceived Self Efficacy (GPSE) self-report questionnaire
Measured: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mood
Measured with Center for Epidemiological Studies Depression Scale (CESD) self-report questionnaire
Measured: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Sleep
Measured with Pittsburgh Sleep Quality Index (PSQI) self-report questionnaire
Measured: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mindfulness
Measured with Five Factor Mindfulness Questionnaire (FFMQ)
Measured: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Perceived Stress
Measured with perceived stress scale (PSS)
Measured: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helane Wahbeh, Oregon Health and Science University
- Investigators
- Barry S Oken, MD, MS, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02655835
- Sponsor's protocol ID
- 10939
- Acronym
- IMMI
- Status last verified
- Oct 2018
- First submitted
- 6 Jan 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 27502759
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Mindfulness Meditation Intervention
- ClinicalTrials.gov ID
- NCT02655835
- Acronym / sponsor ID
- IMMI / 10939
- Conditions
- Stress
- Keywords
- mindfulness, meditation, internet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 14 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet Mindfulness Meditation Intervention | Experimental | Behavioral: Internet Mindfulness MeditationSix-week internet mindfulness meditation training program including handouts and daily guided meditations |
| Access | Experimental | Behavioral: AccessWritten information handouts on mindfulness meditation and access to guided daily meditations |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet Mindfulness Meditation | Behavioural | Internet Mindfulness Meditation Intervention |
| Access | Behavioural | Access |
Primary outcome
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.
Completion Rate
Time frame: Week 8 - Endpoint assessment
Number of participants who complete the endpoint assessment.
6 secondary outcomes
Quality of Life SF-36
Time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Self-efficacy
Time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mood
Time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Sleep
Time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Mindfulness
Time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Perceived Stress
Time frame: Week 1 - Baseline assessment & Week 8 - Endpoint assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Derived from this study: PubMed 27502759Wahbeh 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.
- Individual participant dataSharing planned: No
Related trials for Stress
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Active, not recruiting
Chicago Parent Program for Foster and Kinship Caregivers
Behavior Problem, Parenting
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barry S Oken, MD, MS principal investigator
Oregon Health and Science University
Questions about this trial
What is this clinical trial studying?
A study testing Internet Mindfulness Meditation and Access in people with Stress, run by Oregon Health and Science University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Week 0 - Screening). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02655835, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.