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.
COMPLETED
NA
55 participants
20 days
2025-07-02
Participant Flow
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
| 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 daysThe 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
| 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 daysThe 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
| 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 daysThis 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
| 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
Breathing
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place