Robot-Assisted Meditation for Older Adults With Cognitive Concerns

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorJohns Hopkins University

About this trial

While traditional app-based mindfulness meditation programs relying solely on audio guidance have shown potential benefits for older adults, the programs often face challenges such as low engagement. Participants frequently report difficulties in maintaining focus during meditation sessions, which can limit its effectiveness in improving outcomes such as stress reduction and sleep quality. To address these limitations, this study examines whether a haptic robot that provides both tactile and audio guidance can enhance meditation. The robot's expansion and contraction movements help users pace and sustain rhythmic breathing, while gentle vibrations signal phase transitions without disrupting concentration. These haptic features are intended to anchor attention and support a more embodied practice.

The study primarily seeks to answer the following questions: Does a haptic enabled meditation intervention reduce perceived stress in older adults living alone with subjective cognitive decline more effectively than an audio only mindfulness meditation guidance provided by a non-moving robot? To what extent does enhanced attentional anchoring mediate the intervention's effect on perceived stress in this population? By addressing these questions, the research aims to determine whether haptic enabled meditation technology can overcome common barriers to mindfulness practice among older adults and serve as an innovative tool to reduce perceived stress, and ultimately improve their sleep quality and physical, emotional, and cognitive well being.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants have subjective cognitive decline, assessed using the Subjective Cognitive Decline Questionnaire (SCD-Q)

Disqualifiers

Participants do not have dementia or mild cognitive impairment.

To exclude significant cognitive impairment, investigators will utilize the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robot-Guided Meditation

    Behavioral

    A handheld robot provides daily mindfulness meditation sessions that include both haptic and audio guidance.

  • Audio-Only Robot

    Behavioral

    Participants use the same robot, which remains stationary (no haptic movement) and provides audio-only daily meditation sessions.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Robot-GuidedExperimental treatment 1 intervention
Group B: Non-Moving RobotActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stress level as assessed by the Perceived Stress Scale (PSS)

Perceived Stress Scale (PSS). The total score ranges 0 to 40. Low Stress: 0-13; Moderate Stress: 14-26; High Stress: 27-40. A higher score indicates a higher level of perceived stress.

Time frame
Baseline, 4 weeks, 8 weeks

Secondary outcomes

1

Sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

Pittsburgh Sleep Quality Index (PSQI). The total score range 0 to 21, where a score greater than 5 indicates poor sleep quality. A higher score indicates worse sleep quality.

Time frame
Baseline, 4 weeks, 8 weeks
2

Anxiety as assessed by the Generalized Anxiety Disorder scale (GAD-7)

Generalized Anxiety Disorder scale (GAD-7). The total score ranges from 0 to 21. A score of 10 or higher is often used as a cutoff suggesting clinically significant anxiety. A higher score indicates worse anxiety.

Time frame
Baseline, week 4, week 8

Other outcomes

1

Adherence

Adherence is defined as the number of days a participant completes the required meditation sessions. Adherence will be tracked through self-reported practice logs and usage data.

Time frame
From enrollment up to end of treatment at 8 weeks

Locations

This trial has no locations.

Sponsors and contacts

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