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Clinical Trials/NCT05620511
NCT05620511
Recruiting
Not Applicable

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

Chang Gung Memorial Hospital1 site in 1 country180 target enrollmentAugust 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Late Life Depression
Sponsor
Chang Gung Memorial Hospital
Enrollment
180
Locations
1
Primary Endpoint
Loneliness UCLA
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2020
End Date
July 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Inability to provide informed consent.
  • Dementia, as defined by MMSE \< 24 (\<17 if illiterate or no education) and clinical evidence of dementia based on DSM-5 criteria.
  • Lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
  • Abuse of or dependence on alcohol or other substances within the past 3 months, and confirmed by study physician interview.
  • 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.
  • Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
  • Unstable medical illness, including delirium, uncontrolled diabetes mellitus, hypertension, hyperlipidemia, or cerebrovascular or cardiovascular risk factors that are not under medical management.
  • Currently under psychotherapy or taking regular meditation or yoga practice (or had experience in these activities)

Outcomes

Primary Outcomes

Loneliness UCLA

Time Frame: Change from Baseline at 3 months

the severity of loneliness (the score range from 20-80,the lower score means worse)

Mindfulness

Time Frame: Change from Baseline at 3 months

the effects of mindfulness(the score range from 20-100)

Ham D-17

Time Frame: Change from Baseline at 3 months

the insight(the score range from 0-2,the higher score means worse)

Secondary Outcomes

  • Interleukin-6(Change from Baseline at 3 months)
  • Interleukin-12(Change from Baseline at 3 months)
  • TGF-β1(Change from Baseline at 3 months)
  • structural and functional connectivity(Change from Baseline at 3 months)
  • Verbal Learning & Memory(Change from Baseline at 3 months)
  • Interleukin-1α(Change from Baseline at 3 months)
  • Interleukin-1β(Change from Baseline at 3 months)
  • Total Brain-derived neurotrophic factor(Change from Baseline at 3 months)
  • Free Brain-derived neurotrophic factor(Change from Baseline at 3 months)

Study Sites (1)

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