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Completed

NCT Number: NCT01946893

Mindfulness Meditation for Cognition and Mood

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Recruitment

    Time frame: Week 8

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

  2. Participant satisfaction

    Time frame: Week 8

    Client Satisfaction Questionnaire

Secondary outcomes

  1. Mood

    Time frame: Week 0, Week 8

    Mood (Center for Epidemiologic Studies Depression Scale)

  2. Cognition

    Time frame: 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).

Other outcomes

  1. Perceived Stress Scale

    Time frame: Week 0, Week 8

  2. Pittsburgh Sleep Quality Index

    Time frame: Week 0, Week 8

  3. Mindfulness-Five-factor Mindfulness Scale

    Time frame: Week 0, Week 8

  4. Positive and Negative Affect Scale

    Time frame: Week 0, Week 8

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 20, 2013
Registry last updated
Jul 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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