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

Primary Purpose

Late Life Depression

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Mindfulness based stress reduction
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Late Life Depression focused on measuring elderly depression, Mindfulness-based stress reduction (MBSR), MRI, autonomic nervous system

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Che-min LinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mindfulness based stress reduction

Relaxation

Arm Description

Age > 55 years. Major depressive disorder (MDD). Right handiness with a score ≥ 24 on the MMSE

Age > 55 years. Major depressive disorder (MDD). Right handiness with a score ≥ 24 on the MMSE

Outcomes

Primary Outcome Measures

Loneliness UCLA
the severity of loneliness (the score range from 20-80,the lower score means worse)
Mindfulness
the effects of mindfulness(the score range from 20-100)
Ham D-17
the insight(the score range from 0-2,the higher score means worse)

Secondary Outcome Measures

Verbal Learning & Memory
Word list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)
structural and functional connectivity
Brain MRI connectivity change
Interleukin-1α
IL-1α
Interleukin-1β
IL-1β
Interleukin-6
IL-6
Interleukin-12
IL-12
TGF-β1
TGF-β1
Total Brain-derived neurotrophic factor
Total BDNF
Free Brain-derived neurotrophic factor
Free BDNF

Full Information

First Posted
November 7, 2022
Last Updated
November 14, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05620511
Brief Title
Explore the Neural Mechanism of Mindfulness Training to Reduce Loneliness in Depressed Older Adults
Official Title
Explore the Neural Mechanism of Mindfulness Training to Reduce Loneliness in Depressed Older Adults: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 4, 2020 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Late Life Depression
Keywords
elderly depression, Mindfulness-based stress reduction (MBSR), MRI, autonomic nervous system

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness based stress reduction
Arm Type
Experimental
Arm Description
Age > 55 years. Major depressive disorder (MDD). Right handiness with a score ≥ 24 on the MMSE
Arm Title
Relaxation
Arm Type
Placebo Comparator
Arm Description
Age > 55 years. Major depressive disorder (MDD). Right handiness with a score ≥ 24 on the MMSE
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction
Intervention Description
Mindfulness based stress reduction v.s.Relaxation
Primary Outcome Measure Information:
Title
Loneliness UCLA
Description
the severity of loneliness (the score range from 20-80,the lower score means worse)
Time Frame
Change from Baseline at 3 months
Title
Mindfulness
Description
the effects of mindfulness(the score range from 20-100)
Time Frame
Change from Baseline at 3 months
Title
Ham D-17
Description
the insight(the score range from 0-2,the higher score means worse)
Time Frame
Change from Baseline at 3 months
Secondary Outcome Measure Information:
Title
Verbal Learning & Memory
Description
Word list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)
Time Frame
Change from Baseline at 3 months
Title
structural and functional connectivity
Description
Brain MRI connectivity change
Time Frame
Change from Baseline at 3 months
Title
Interleukin-1α
Description
IL-1α
Time Frame
Change from Baseline at 3 months
Title
Interleukin-1β
Description
IL-1β
Time Frame
Change from Baseline at 3 months
Title
Interleukin-6
Description
IL-6
Time Frame
Change from Baseline at 3 months
Title
Interleukin-12
Description
IL-12
Time Frame
Change from Baseline at 3 months
Title
TGF-β1
Description
TGF-β1
Time Frame
Change from Baseline at 3 months
Title
Total Brain-derived neurotrophic factor
Description
Total BDNF
Time Frame
Change from Baseline at 3 months
Title
Free Brain-derived neurotrophic factor
Description
Free BDNF
Time Frame
Change from Baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Che-min Lin, bachelor
Phone
0975366297
Email
8902008@cgmh.org.tw
Facility Information:
Facility Name
Che-min Lin
City
Keelung
ZIP/Postal Code
204
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Che-min Lin, Bachelor
Phone
0975366297
Email
8902008@cgmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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

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