Mindfulness Meditation for Cognition and Mood

Not Applicable

Completed

• Conditions: Stress, Psychological
• Interventions: Behavioral: Mindfulness Meditation; Behavioral: Education

• Registration Number: NCT01946893
• Lead Sponsor: Oregon Health and Science University

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2013-09-17
• Study First Posted: 2013-09-20
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Read More

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)

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness Meditation	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.
Education	Education	Education sessions- 1 session per week for 6 weeks on study iPAD.

Primary Outcome Measures

Name	Time	Method
Recruitment	Week 8	Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study.
Participant satisfaction	Week 8	Client Satisfaction Questionnaire

Secondary Outcome Measures

Name	Time	Method
Mood	Week 0, Week 8	Mood (Center for Epidemiologic Studies Depression Scale)
Cognition	Week 0, Week 8	Simple Reaction Time, Flanker Task, Letter-Number Sequencing, Phonetic and Semantic Verbal Fluency, and AVLT Rey Auditory-Verbal Learning Test (AVLT).