Mindfulness Meditation for Cognition and Mood

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

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological
• Intervention / Treatment: Behavioral: Mindfulness Meditation; Behavioral: Education

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 90 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A standardized and structured program based on Mindfulness Based Cognitive Therapy and Mindfulness Based Stress Reduction and has been piloted in our laboratory.Each session included 1) discussion on stress, relaxation, meditation, and mind-body interaction, 2) instruction and practice in formal and informal MM, and 3) enquiry about problem-solving techniques regarding success and difficulty in practicing mindfulness. Formal meditation instruction included a mindful Body Scan and Sitting Meditation (awareness of breath, body sensations, cognitive and emotional processes). Informal practice of mindful daily activities (e.g., washing dishes) was also taught to generalize mindfulness beyond the formal meditations. A 3-minute meditation was offered as a quick coping strategy, and it could be practiced with or without a guided recording.
Active Comparator: Education; Education sessions- 1 session per week for 6 weeks on study iPAD.	Behavioral: Education; The Education control was matched for session time and home practice. The internet sessions included a general health video and questions about the material. For home practice, the participants listened to podcasts about the same topic. The session topics were 1) Healthy Eating, 2) Healthy Exercise, 3) Healthy Sleep, 4) Healthy Brain, 5) Healthy Mood, and 6) Community Involvement.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Perceived Stress Scale	Week 0, Week 8
Pittsburgh Sleep Quality Index	Week 0, Week 8
Mindfulness-Five-factor Mindfulness Scale	Week 0, Week 8
Positive and Negative Affect Scale	Week 0, Week 8

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Helane Wahbeh, Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: September 12, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: meditation; education; aged; stress, psychological
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: IRB00009841