National College of Natural Medicine
Portland, Oregon, 97201, United States
NCT Number: NCT02340754
The primary purpose of this study is to assess the feasibility of mindfulness-based stress reduction (MBSR) for adults with any type of multiple sclerosis. The secondary objectives are to: 1) Explore the ability of MBSR to improve perceived stress and quality of life compared to an education control group; and 2) Explore the durability of the effects of MBSR over one year.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Portland, Oregon, 97201, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: MBSR
Time frame: Recruitment will be tracked monthly with an expected recruitment period of 10 months..
Feasible recruitment is defined as the ability to recruit and enroll 60 participants with multiple sclerosis (MS) over a ten-month time frame. Recruitment rate will be calculated as the proportion of eligible patients who provided informed consent per month.
Time frame: Baseline to 8 weeks
Adherence will be tracked with a sign-in/sign out sheet at each class and with daily homework logs. Attendance will be calculated by a sign in/sign out sheet, being present for at least 75% of a class will count as attended. Homework will be tabulated as both a frequency count (number of days homework was completed) and amount (total number of minutes completed). Participants who are present for at least 5 of the classes, including the final class, and complete at least 70% of homework will be recorded as 'adherent'.
Time frame: Week 4 and week 8 of the 8 week intervention.
Adoption is defined as the ability of participants to take part in activities such as yoga poses and meditative exercises. Qualitative outcomes include a brief, semi-structured focus group conducted at the beginning of the MBSR classes during weeks five and eight. Focus groups will address successes and any challenges participants may be experiencing. Focus groups will be audio recorded and transcribed verbatim for qualitative analysis.
Time frame: 14 months
A feasible completion rate is defined as complete follow-up in at least 70% of enrolled subjects at 12-months post-intervention. Completion indicates acceptability of a long-term trial and will inform future study designs.
Time frame: Baseline and 8 weeks
Time frame: 8 weeks and 12 months
Time frame: Baseline and 8 weeks
Mental health-related quality of life.
Time frame: 8 weeks and 12 months
Mental health-related quality of life.
Time frame: Baseline and 8 weeks
PROMIS Computerized Adaptive Test of Anxiety
Time frame: 8 weeks and 12 months
PROMIS Computerized Adaptive Test of Anxiety
Time frame: Baseline and 8 weeks
PROMIS Computerized Adaptive Test of Depression
Time frame: 8 weeks and 12 months
PROMIS Computerized Adaptive Test of Depression
Time frame: Baseline and 8 weeks
PROMIS Computerized Adaptive Test of Fatigue
Time frame: 8 weeks and 12 months
PROMIS Computerized Adaptive Test of Fatigue
Time frame: Baseline and 8 weeks
PROMIS Computerized Adaptive Test of Pain
Time frame: 8 weeks and 12 months
PROMIS Computerized Adaptive Test of Pain
National University of Natural Medicine
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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