Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01946893
Other study ID # IRB00009841
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT04549194 - Contribution of L-Tyrosine to Recovery From Operational Strain on Return From External Operation N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Completed NCT03170752 - Implementing and Testing a Cardiovascular Assessment Screening Program (CASP) N/A
Recruiting NCT05419934 - EMDR Therapy in Young Children, a Double-blinded Randomized Controlled Trial N/A
Completed NCT03689348 - Acute and Chronic Effects of Avena Sativa on Cognition and Stress N/A
Active, not recruiting NCT05114824 - Acceptability and Feasibility of an 8-week Online Mindfulness-Based Cognitive Therapy Program Among Undergraduate Students N/A
Recruiting NCT05991739 - Pilot Testing of a Structural Racism Intervention for Immigrant Latinx Families N/A
Not yet recruiting NCT05491122 - The Influence of Fluid Intake on Daily Biological Rhythm and Mental Performance in Healthy Young Adults N/A
Completed NCT02844478 - Stress-Busting Program and QoL, Bio-markers of Immunity/Stress and Cellular Aging N/A
Completed NCT02982070 - TU Tough: Mental Toughness Training for College Success N/A
Completed NCT02417454 - Study on the Effects of a Probiotic on Autonomic and Psychological Stress Phase 3
Completed NCT06014970 - The Health and Wellness Curriculum Assessment N/A
Completed NCT01637363 - Psychoeducation to Sick-listed Individuals With Mental Health Problems N/A
Completed NCT01343810 - Stress Reduction Training to Improve Sleep Quality, Stress Physiology & Cardiovascular Disease (CVD) Risk Markers N/A
Completed NCT00661271 - Mindfulness-based Stress Reduction for Urban Youth N/A
Recruiting NCT04417153 - Who Benefits More? Optimising Mindfulness Based Interventions for Improved Psychological Outcomes
Completed NCT04125810 - A Study to Assess the Safety and Efficacy of Probiotic to Modulate Psychological Stress Phase 2
Completed NCT04023968 - Student Wellness Workshop Study N/A
Completed NCT03233750 - Simulation-Based Stress Inoculation Training N/A
Completed NCT04361045 - StriveWeekly: Self-Guided Online Intervention for Anxiety, Depression, and Stress in University Students N/A