Trial Outcomes & Findings for Mindfulness to Reduce Loneliness in Older Caregivers (NCT NCT04560088)

NCT ID: NCT04560088

Last Updated: 2025-07-02

Results Overview

The FFMQ assesses five factors that represent mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience, and a total score indicating overall mindfulness. The 39 items of the FFMQ are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). The total score ranges from 39-195, with higher scores indicating greater mindfulness. Data presented is for the total FFMQ score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

20 days

Results posted on

2025-07-02

Participant Flow

Participant milestones

Participant milestones
Measure
Mindfulness
Mindfulness using an individual mobile health mindfulness-based intervention training. These sessions are intended to act as a general introduction to mindfulness meditation and incorporate techniques such as breath awareness and body scanning. Mindfulness: Mindfulness-based mobile health intervention.
Breathing
Breathing control intervention will use an individual breathing app. The intervention is designed to be structurally equivalent to the mindfulness-based study intervention on key common factors of psychosocial interventions: (a) the number of sessions, (b) the length of sessions, and (c) delivery format. Breathing: Breathing mobile health intervention.
Overall Study
STARTED
24
31
Overall Study
COMPLETED
19
30
Overall Study
NOT COMPLETED
5
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness to Reduce Loneliness in Older Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindfulness
n=24 Participants
Mindfulness using an individual mobile health mindfulness-based intervention training. These sessions are intended to act as a general introduction to mindfulness meditation and incorporate techniques such as breath awareness and body scanning. Mindfulness: Mindfulness-based mobile health intervention.
Breathing
n=31 Participants
Breathing control intervention will use an individual breathing app. The intervention is designed to be structurally equivalent to the mindfulness-based study intervention on key common factors of psychosocial interventions: (a) the number of sessions, (b) the length of sessions, and (c) delivery format. Breathing: Breathing mobile health intervention.
Total
n=55 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=39 Participants
19 Participants
n=41 Participants
33 Participants
n=35 Participants
Age, Categorical
>=65 years
10 Participants
n=39 Participants
12 Participants
n=41 Participants
22 Participants
n=35 Participants
Age, Continuous
65 years
n=39 Participants
64 years
n=41 Participants
64 years
n=35 Participants
Sex: Female, Male
Female
22 Participants
n=39 Participants
27 Participants
n=41 Participants
49 Participants
n=35 Participants
Sex: Female, Male
Male
2 Participants
n=39 Participants
4 Participants
n=41 Participants
6 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
24 Participants
n=39 Participants
31 Participants
n=41 Participants
55 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=39 Participants
0 Participants
n=41 Participants
1 Participants
n=35 Participants
Race (NIH/OMB)
Asian
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=39 Participants
3 Participants
n=41 Participants
4 Participants
n=35 Participants
Race (NIH/OMB)
White
22 Participants
n=39 Participants
28 Participants
n=41 Participants
50 Participants
n=35 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=39 Participants
0 Participants
n=41 Participants
0 Participants
n=35 Participants
Region of Enrollment
United States
24 participants
n=39 Participants
31 participants
n=41 Participants
55 participants
n=35 Participants

PRIMARY outcome

Timeframe: 20 days

The FFMQ assesses five factors that represent mindfulness as it is currently conceptualized: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience, and a total score indicating overall mindfulness. The 39 items of the FFMQ are rated on a 5-point Likert scale, ranging from 1 (never or very rarely true) to 5 (very often or always true). The total score ranges from 39-195, with higher scores indicating greater mindfulness. Data presented is for the total FFMQ score.

Outcome measures

Outcome measures
Measure
Mindfulness
n=24 Participants
Mindfulness using an individual mobile health mindfulness-based intervention training. These sessions are intended to act as a general introduction to mindfulness meditation and incorporate techniques such as breath awareness and body scanning. Mindfulness: Mindfulness-based mobile health intervention.
Breathing
n=31 Participants
Breathing control intervention will use an individual breathing app. The intervention is designed to be structurally equivalent to the mindfulness-based study intervention on key common factors of psychosocial interventions: (a) the number of sessions, (b) the length of sessions, and (c) delivery format. Breathing: Breathing mobile health intervention.
Five Facet Mindfulness Questionnaire (FFMQ)
Baseline (Time 1)
137.83 score on a scale
Standard Deviation 21.92
127.81 score on a scale
Standard Deviation 20.01
Five Facet Mindfulness Questionnaire (FFMQ)
Day 20 (Time 2)
137.42 score on a scale
Standard Deviation 20.19
134.32 score on a scale
Standard Deviation 21.99

PRIMARY outcome

Timeframe: 20 days

The DERS is a 36-item self-report measure that assesses emotion dysregulation in six domains: nonacceptance of emotional responses, difficulties engaging in goal directed behavior, impulse control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. The DERS has demonstrated high internal consistency in clinical and nonclinical samples, good test-retest reliability over 8-weeks, construct validity, and sensitivity to change over time following interventions, including acceptance and mindfulness therapies. Items are rated on a scale of 1 ("almost never \[0-10%\]") to 5 ("almost always \[91-100%\]"). Scores range from 36-180, with higher scores indicating more difficulty in emotion regulation. Data presented is for the total DERS score.

Outcome measures

Outcome measures
Measure
Mindfulness
n=24 Participants
Mindfulness using an individual mobile health mindfulness-based intervention training. These sessions are intended to act as a general introduction to mindfulness meditation and incorporate techniques such as breath awareness and body scanning. Mindfulness: Mindfulness-based mobile health intervention.
Breathing
n=31 Participants
Breathing control intervention will use an individual breathing app. The intervention is designed to be structurally equivalent to the mindfulness-based study intervention on key common factors of psychosocial interventions: (a) the number of sessions, (b) the length of sessions, and (c) delivery format. Breathing: Breathing mobile health intervention.
Difficulties in Emotion Regulation Scale (DERS)
Baseline (Time 1)
67.25 score on a scale
Standard Deviation 17.68
86.45 score on a scale
Standard Deviation 25.11
Difficulties in Emotion Regulation Scale (DERS)
Day 20 (Time 2)
70.32 score on a scale
Standard Deviation 26.85
78.19 score on a scale
Standard Deviation 22.67

PRIMARY outcome

Timeframe: 20 days

This assessment has demonstrated excellent internal consistency, test re-test reliability, and construct validity (associations with social support, social network size). Each question is rated on a 3-point scale: 1 = Hardly Ever; 2 = Some of the Time; 3 = Often. All items are summed to give a total score, ranging from 3-9 points. Higher scores indicate more loneliness.

Outcome measures

Outcome measures
Measure
Mindfulness
n=24 Participants
Mindfulness using an individual mobile health mindfulness-based intervention training. These sessions are intended to act as a general introduction to mindfulness meditation and incorporate techniques such as breath awareness and body scanning. Mindfulness: Mindfulness-based mobile health intervention.
Breathing
n=31 Participants
Breathing control intervention will use an individual breathing app. The intervention is designed to be structurally equivalent to the mindfulness-based study intervention on key common factors of psychosocial interventions: (a) the number of sessions, (b) the length of sessions, and (c) delivery format. Breathing: Breathing mobile health intervention.
The UCLA 3-Item Loneliness Scale
Baseline (Time 1)
6.04 score on a scale
Standard Deviation 1.92
7 score on a scale
Standard Deviation 1.73
The UCLA 3-Item Loneliness Scale
Day 20 (Time 2)
6.44 score on a scale
Standard Deviation 1.92
6.35 score on a scale
Standard Deviation 1.70

Adverse Events

Mindfulness

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Breathing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Mindfulness
n=24 participants at risk
Mindfulness using an individual mobile health mindfulness-based intervention training. These sessions are intended to act as a general introduction to mindfulness meditation and incorporate techniques such as breath awareness and body scanning. Mindfulness: Mindfulness-based mobile health intervention.
Breathing
n=31 participants at risk
Breathing control intervention will use an individual breathing app. The intervention is designed to be structurally equivalent to the mindfulness-based study intervention on key common factors of psychosocial interventions: (a) the number of sessions, (b) the length of sessions, and (c) delivery format. Breathing: Breathing mobile health intervention.
Social circumstances
Interpersonal threat
4.2%
1/24 • 20 days
0.00%
0/31 • 20 days

Other adverse events

Adverse event data not reported

Additional Information

Autumn Gallegos, PhD

University of Rochester Medical Center

Phone: 5852752824

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place