Mindfulness Meditation for Cognition and Mood

NCT01946893 | Completed

• 1 other identifier: IRB00009841
• Study Type: interventional
• Target: 21
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress, Psychological

Keywords

meditation; education; stress, psychological; aged

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Mood

  Week 0, Week 8

• Cognition

  Week 0, Week 8

Other Outcomes (4)

• Perceived Stress Scale

  Week 0, Week 8

• Pittsburgh Sleep Quality Index

  Week 0, Week 8

• Mindfulness-Five-factor Mindfulness Scale

  Week 0, Week 8

Study Arms (2)

Mindfulness Meditation

EXPERIMENTAL

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

Education

ACTIVE COMPARATOR

Education sessions- 1 session per week for 6 weeks on study iPAD.

Behavioral: Education

Interventions

Mindfulness Meditation BEHAVIORAL

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.

Mindfulness Meditation

Education BEHAVIORAL

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.

Education

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness; Educational Status

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Socioeconomic Factors; Population Characteristics

Study Officials

• Helane Wahbeh

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 20, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: July 13, 2015

Record last verified: 2015-07