Mindfulness Meditation for Cognition and Mood

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946893
• Other study ID #: IRB00009841
• Status: Completed
• Phase: N/A
• First received: September 12, 2013
• Last updated: July 9, 2015
• Start date: September 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Stress, Psychological

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived Stress Scale		Week 0, Week 8	No
Other	Pittsburgh Sleep Quality Index		Week 0, Week 8	No
Other	Mindfulness-Five-factor Mindfulness Scale		Week 0, Week 8	No
Other	Positive and Negative Affect Scale		Week 0, Week 8	No
Primary	Recruitment	Enrollment and dropout rates will be calculated for each participant and summarized for all participants in the study.	Week 8	No
Primary	Participant satisfaction	Client Satisfaction Questionnaire	Week 8	No
Secondary	Mood	Mood (Center for Epidemiologic Studies Depression Scale)	Week 0, Week 8	No
Secondary	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	No