Loneliness, Social Isolation
Conditions
Keywords
Mindfulness, Caregiver, Alzheimer's Disease, Dementia
Brief summary
The objective of this pilot study is to provide initial evidence of the role of mindfulness training in improving social disconnectedness - including social isolation and feelings of loneliness - in older caregivers for family members with ADRD. The investigators propose a two-arm randomized control trial: participants will be randomized to (a) smartphone-based MBSR app (Headspace) or (b) active control (breathing app) for 14 days. Loneliness and quality of social interactions will be assessed using Ecological Momentary Assessment at baseline and 14-days after randomization.
Detailed description
Social isolation and feelings of loneliness are risk factors for older caregivers for family members with Alzheimer's Disease and Related Dementias (ADRD). Further, social isolation and loneliness place older caregivers at risk of poor health, including increased inflammation, cardiovascular disease, depression, and premature mortality. Interventions to promote social connectedness in older caregivers have the potential to reduce elevated morbidity and premature mortality and buffer the high caregiving burden in this growing but understudied population. Thus, developing effective treatments to reduce social disconnectedness in older adults is essential, but previous behavioral treatment efforts have had limited success. Mindfulness-based interventions may reduce loneliness in older adults, as demonstrated in a randomized controlled trial of an 8-week mindfulness-based stress reduction program. Another recent study demonstrated the efficacy of a smartphone-based mindfulness training for reducing loneliness and increasing social contact in daily life among adults reporting above average stress; however, smartphone-based mindfulness training interventions have not been tested with older adults, nor have they been tested with caregivers of family members with ADRD. Specifically, prior studies were conducted with healthy adults not necessarily burdened by caregiving; it remains unknown how caregiver stress --related to competing demands on time and significant loneliness --may impact the ability to comply with the intervention as well as indicate barriers to efficacy. The current study will follow a similar protocol as the aforementioned randomized controlled trial that used a smartphone-based mindfulness training to address loneliness and social contact.
Interventions
BEHAVIORALMindfulness
Mindfulness-based mobile health intervention.
BEHAVIORALBreathing
Breathing mobile health intervention.
Sponsors
National Institute on Aging (NIA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* English speaking. * Caregiver for a community-dwelling family member with ADRD, living with (or in close proximity to) family member with dementia. * Elevated caregiving distress: above population mean (\>11) on 10-item Perceived Stress Scale (PSS-10) and/or at least moderate caregiver strain (score \>= 5) on the Modified Caregiver Strain Index (MCSI). * Social disconnectedness: UCLA Loneliness Scale: Short Form score of \>6 (except for n=5 in Aim 1 who report feeling socially connected). * Access to e-mail in order to complete the e-consent module in REDCap which will be used in this study.
Exclusion criteria
* Non-English speaking because our primary community partner agency (Lifespan) cannot currently accommodate non-English speaking clients. * Current problem drinking will be assessed using the AUDIT-C during the phone screen (score of 5 or greater indicating exclusion). * Modules from the Mini International Neuropsychiatric Exam (MINI) will be used to exclude subjects who have these psychiatric conditions: current non-alcohol psychoactive substance abuse, psychotic disorders (current and lifetime), bipolar disorder, and current mood disorder with psychotic features. * Those with significant cognitive impairment on a cognitive screening measure at the HARP screening assessment. * In order to test the effects of developing mindfulness skills in a novice population, those with a regular systematic mindfulness meditation or related mind-body practice (\>2 times per week) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Five Facet Mindfulness Questionnaire (FFMQ) | 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. |
| Difficulties in Emotion Regulation Scale (DERS) | 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. |
| The UCLA 3-Item Loneliness Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| 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. | 31 |
| Total | 55 |
Baseline characteristics
| Characteristic | Mindfulness | Breathing | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 10 Participants | 12 Participants | 22 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 19 Participants | 33 Participants |
| Age, Continuous | 65 years | 64 years | 64 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants | 31 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 28 Participants | 50 Participants |
| Region of Enrollment United States | 24 participants | 31 participants | 55 participants |
| Sex: Female, Male Female | 22 Participants | 27 Participants | 49 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 31 |
| other Total, other adverse events | 0 / 24 | 0 / 31 |
| serious Total, serious adverse events | 1 / 24 | 0 / 31 |
Outcome results
Primary
Difficulties in Emotion Regulation Scale (DERS)
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.
Time frame: 20 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness | Difficulties in Emotion Regulation Scale (DERS) | Baseline (Time 1) | 67.25 score on a scale | Standard Deviation 17.68 |
| Mindfulness | Difficulties in Emotion Regulation Scale (DERS) | Day 20 (Time 2) | 70.32 score on a scale | Standard Deviation 26.85 |
| Breathing | Difficulties in Emotion Regulation Scale (DERS) | Baseline (Time 1) | 86.45 score on a scale | Standard Deviation 25.11 |
| Breathing | Difficulties in Emotion Regulation Scale (DERS) | Day 20 (Time 2) | 78.19 score on a scale | Standard Deviation 22.67 |
Primary
Five Facet Mindfulness Questionnaire (FFMQ)
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.
Time frame: 20 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness | Five Facet Mindfulness Questionnaire (FFMQ) | Baseline (Time 1) | 137.83 score on a scale | Standard Deviation 21.92 |
| Mindfulness | Five Facet Mindfulness Questionnaire (FFMQ) | Day 20 (Time 2) | 137.42 score on a scale | Standard Deviation 20.19 |
| Breathing | Five Facet Mindfulness Questionnaire (FFMQ) | Baseline (Time 1) | 127.81 score on a scale | Standard Deviation 20.01 |
| Breathing | Five Facet Mindfulness Questionnaire (FFMQ) | Day 20 (Time 2) | 134.32 score on a scale | Standard Deviation 21.99 |
Primary
The UCLA 3-Item Loneliness Scale
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.
Time frame: 20 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness | The UCLA 3-Item Loneliness Scale | Baseline (Time 1) | 6.04 score on a scale | Standard Deviation 1.92 |
| Mindfulness | The UCLA 3-Item Loneliness Scale | Day 20 (Time 2) | 6.44 score on a scale | Standard Deviation 1.92 |
| Breathing | The UCLA 3-Item Loneliness Scale | Day 20 (Time 2) | 6.35 score on a scale | Standard Deviation 1.7 |
| Breathing | The UCLA 3-Item Loneliness Scale | Baseline (Time 1) | 7 score on a scale | Standard Deviation 1.73 |