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Clinical Trials/NCT01946893
NCT01946893
Completed
Not Applicable

Mindfulness Meditation for Cognition and Mood: A Pilot Study Evaluating Feasibility and Collecting Preliminary Data

Oregon Health and Science University0 sites21 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress, Psychological
Sponsor
Oregon Health and Science University
Enrollment
21
Primary Endpoint
Recruitment
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Helane Wahbeh

Assistant Professor

Oregon Health and Science University

Eligibility 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)

Outcomes

Primary Outcomes

Recruitment

Time Frame: Week 8

Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study.

Participant satisfaction

Time Frame: Week 8

Client Satisfaction Questionnaire

Secondary Outcomes

  • Mood(Week 0, Week 8)
  • Cognition(Week 0, Week 8)

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