Skip to content

Explore the Neural Mechanism of Mindfulness Training to Reduce Loneliness in Depressed Older Adults

Explore the Neural Mechanism of Mindfulness Training to Reduce Loneliness in Depressed Older Adults: a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05620511
Enrollment
180
Registered
2022-11-17
Start date
2020-08-01
Completion date
2023-07-31
Last updated
2022-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late Life Depression

Keywords

elderly depression, Mindfulness-based stress reduction (MBSR), MRI, autonomic nervous system

Brief summary

Perceived loneliness causes a global health burden on older adults. Mindfulness training may be a feasible solution. Through our study, we expect that comprehensive and convincing neuroscientific evidence may support the efficacy underpinning mindfulness training in loneliness reduction.

Detailed description

In this aging and highly industrial society, elderly depression, particularly elderly loneliness, is a growing societal issue. Perceived loneliness not only causes tremendous suffering, disability, cognitive decline, and risk of dementia but also leads to increased mortality. Despite worldwide effort to solve the growing prevalence of loneliness in older adults, no single intervention stands out as universally effective and practical. The exact neural mechanism of loneliness and how the intervention against loneliness takes its effect in the brain remain unclear. Prior studies have indicated that perceived loneliness is associated with distorted cognition toward interpersonal interaction and heightened sympathetic nerve system.Mindfulness training is a discipline that the older adults in our society can readily relate to because the philosophy of mindfulness is similar to Buddhism. Mindfulness trains people to be aware of the surrounding environment and their presence in this environment. Combining the exercises of deep breathing and relaxation, one is taught to be aware of the emotion of oneself to regulate emotion. Mindfulness-based stress reduction (MBSR), a validated and systemized intervention, has been applied to the treatment of depression, anxiety, and insomnia. On the basis of the theory of mindfulness, the investigators estimate that mindfulness can reduce loneliness as well. Thus, the investigators aim to use MBSR in a group of older adults with depression to reduce loneliness. Our previous studies demonstrated that loneliness decreases the grey matter volume in reward system, disrupts the white matter structure, and heightens default-mode network activation. By combining a wearable device for sleep monitoring, heart rate variability measurement, and immune-related cytokine blood test, the investigators can associate these changes with clinical loneliness reduction and brain changes from magnetic resonance imaging. The investigators hope to validate MBSR as an effective intervention against loneliness and explore the supporting neural mechanism.

Interventions

BEHAVIORALMindfulness based stress reduction

Mindfulness based stress reduction v.s.Relaxation

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age \> 55 years. 2. Major depressive disorder (MDD).

Exclusion criteria

1. Inability to provide informed consent. 2. Dementia, as defined by MMSE \< 24 (\<17 if illiterate or no education) and clinical evidence of dementia based on DSM-5 criteria. 3. Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms. 4. Abuse of or dependence on alcohol or other substances within the past 3 months, and confirmed by study physician interview. 5. High risk for suicide (e.g., active suicide ideation and/or current/recent intent or plan) AND unable to be managed safely in the clinical trial (e.g., unwilling to be hospitalized). Urgent psychiatric referral will be made in these cases. 6. Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview). 7. Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management. 8. Currently under psychotherapy or taking regular meditation or yoga practice (or had experience in these activities)

Design outcomes

Primary

MeasureTime frameDescription
Loneliness UCLAChange from Baseline at 3 monthsthe severity of loneliness (the score range from 20-80,the lower score means worse)
MindfulnessChange from Baseline at 3 monthsthe effects of mindfulness(the score range from 20-100)
Ham D-17Change from Baseline at 3 monthsthe insight(the score range from 0-2,the higher score means worse)

Secondary

MeasureTime frameDescription
Interleukin-1βChange from Baseline at 3 monthsIL-1β
Interleukin-6Change from Baseline at 3 monthsIL-6
Interleukin-12Change from Baseline at 3 monthsIL-12
Verbal Learning & MemoryChange from Baseline at 3 monthsWord list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)
Total Brain-derived neurotrophic factorChange from Baseline at 3 monthsTotal BDNF
Free Brain-derived neurotrophic factorChange from Baseline at 3 monthsFree BDNF
TGF-β1Change from Baseline at 3 monthsTGF-β1
structural and functional connectivityChange from Baseline at 3 monthsBrain MRI connectivity change
Interleukin-1αChange from Baseline at 3 monthsIL-1α

Countries

Taiwan

Contacts

Primary ContactChe-min Lin, bachelor
8902008@cgmh.org.tw0975366297

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026