Mindfulness Meditation for Cognition and Mood

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Helane Wahbeh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01946893
First received: September 12, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

The purpose of this pilot study is to collect feasibility and acceptability of an internet mindfulness meditation intervention for older adults and to collect preliminary data on mood and cognition changes from before to after the intervention. Up to 32 older adults will be randomized to receive a mindfulness meditation intervention or a time and attention control, both delivered over the internet (16 completers). Participants will have a one-hour session weekly for six weeks with daily home practice between sessions. Participants will complete the sessions online with a study iPad. Their home practice will also be installed on the study iPad as well as an objective adherence monitoring program that the investigators developed to track actual home practice between sessions. The feasibility and acceptability measures are enrollment rate, completion rate, and participant satisfaction. Self-report mood questionnaires and cognitive tasks will be measured before and after the intervention period and data used to conduct power analyses and sample size estimation for a larger clinical trial.


Condition Intervention
Stress, Psychological
Aged
Behavioral: Mindfulness Meditation
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Official Title: Mindfulness Meditation for Cognition and Mood: A Pilot Study Evaluating Feasibility and Collecting Preliminary Data

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Recruitment [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study.

  • Participant satisfaction [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Client Satisfaction Questionnaire


Secondary Outcome Measures:
  • Mood [ Time Frame: Week 0, Week 8 ] [ Designated as safety issue: No ]
    Mood (Center for Epidemiologic Studies Depression Scale)

  • Cognition [ Time Frame: Week 0, Week 8 ] [ Designated as safety issue: No ]
    Simple Reaction Time, Flanker Task, Letter-Number Sequencing, Phonetic and Semantic Verbal Fluency, and AVLT Rey Auditory-Verbal Learning Test (AVLT).


Other Outcome Measures:
  • Perceived Stress Scale [ Time Frame: Week 0, Week 8 ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: Week 0, Week 8 ] [ Designated as safety issue: No ]
  • Mindfulness-Five-factor Mindfulness Scale [ Time Frame: Week 0, Week 8 ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Scale [ Time Frame: Week 0, Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness Meditation
One session per week for 6 weeks online through study iPAD. The intervention is a standardized and structured program. The objectives are to: 1) help participants understand their personal reactions to stress, 2) teach them skills to modify their stress reactions, and 3) promote their desire for self-care and feelings of competence and mastery.
Behavioral: Mindfulness Meditation
Active Comparator: Education
Education sessions- 1 session per week for 6 weeks on study iPAD.
Behavioral: Education

  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 65 - 90 years old
  • Baseline Perceived Stress Scale1 score ≥ 9
  • Stable on medications six weeks prior to and during study
  • Willing to learn and use study technology
  • Can hear and understand instructions
  • Willing to accept randomization scheme and agrees to follow the study protocol

Exclusion Criteria:

  • Cognitive impairment limiting ability to give consent or follow the protocol (≤26 on the mTICS)2
  • Significant acute medical illness that would decrease likelihood of study completion (self-report).
  • Significant, untreated depression, as assessed by CESD-5 >16 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946893

Contacts
Contact: Helane Wahbeh wahbehh@ohsu.edu

Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Helane Wahbeh Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Helane Wahbeh, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01946893     History of Changes
Other Study ID Numbers: IRB00009841
Study First Received: September 12, 2013
Last Updated: September 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
meditation
education
stress, psychological
aged

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 01, 2014