Late Life DepressionNCT05620511
Explore the Neural Mechanism of Mindfulness Training to Reduce Loneliness in Depressed Older Adults
A study testing Mindfulness based stress reduction in people with Late Life Depression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Late Life Depression
- What is being tested?
- Mindfulness based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2020to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 55 years.
- Major depressive disorder (MDD).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Che-min Lin
Keelung, 204
Che-min Lin, Bachelor, 0975366297, 8902008@cgmh.org.tw
About this study
Official title: Explore the Neural Mechanism of Mindfulness Training to Reduce Loneliness in Depressed Older Adults: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Late Life Depression
- Being tested
- Mindfulness based stress reduction
- Keywords
- elderly depression, Mindfulness-based stress reduction (MBSR), MRI, autonomic nervous system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based stress reductionBehavioural
Mindfulness based stress reduction v.s.Relaxation
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based stress reduction | Experimental | 1. Age > 55 years.
2. Major depressive disorder (MDD).
3. Right handiness
4. with a score ≥ 24 on the MMSE Receives: Behavioral: Mindfulness based stress reduction |
| Relaxation | Placebo comparator | 1. Age > 55 years.
2. Major depressive disorder (MDD).
3. Right handiness
4. with a score ≥ 24 on the MMSE Receives: Behavioral: Mindfulness based stress reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loneliness UCLA
the severity of loneliness (the score range from 20-80,the lower score means worse)
Measured: Change from Baseline at 3 months
Mindfulness
the effects of mindfulness(the score range from 20-100)
Measured: Change from Baseline at 3 months
Ham D-17
the insight(the score range from 0-2,the higher score means worse)
Measured: Change from Baseline at 3 months
Secondary outcomes (9)
Verbal Learning & Memory
Word list of Wechsler Memory Scale-III Face memory task(the score range from 0-48,the higher score means better)
Measured: Change from Baseline at 3 months
structural and functional connectivity
Brain MRI connectivity change
Measured: Change from Baseline at 3 months
Interleukin-1α
IL-1α
Measured: Change from Baseline at 3 months
Interleukin-1β
IL-1β
Measured: Change from Baseline at 3 months
Interleukin-6
IL-6
Measured: Change from Baseline at 3 months
Interleukin-12
IL-12
Measured: Change from Baseline at 3 months
TGF-β1
TGF-β1
Measured: Change from Baseline at 3 months
Total Brain-derived neurotrophic factor
Total BDNF
Measured: Change from Baseline at 3 months
Free Brain-derived neurotrophic factor
Free BDNF
Measured: Change from Baseline at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Aug 2020
- Primary completion4 Dec 2020
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Late Life DepressionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620511
- Sponsor's protocol ID
- 201902151A3
- Status last verified
- Nov 2022
- First submitted
- 7 Nov 2022
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explore the Neural Mechanism of Mindfulness Training to Reduce Loneliness in Depressed Older Adults: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05620511
- Acronym / sponsor ID
- 201902151A3
- Conditions
- Late Life Depression
- Keywords
- elderly depression, Mindfulness-based stress reduction (MBSR), MRI, autonomic nervous system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based stress reduction | Experimental | Behavioral: Mindfulness based stress reduction1. Age > 55 years. 2. Major depressive disorder (MDD). 3. Right handiness 4. with a score ≥ 24 on the MMSE |
| Relaxation | Placebo comparator | Behavioral: Mindfulness based stress reduction1. Age > 55 years. 2. Major depressive disorder (MDD). 3. Right handiness 4. with a score ≥ 24 on the MMSE |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 55 years.
- Major depressive disorder (MDD).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based stress reductionMindfulness based stress reduction v.s.Relaxation | Behavioural | Mindfulness based stress reduction, Relaxation |
Primary outcome
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)
9 secondary outcomes
Verbal Learning & Memory
Time frame: Change from Baseline at 3 months
structural and functional connectivity
Time frame: Change from Baseline at 3 months
Interleukin-1α
Time frame: Change from Baseline at 3 months
Interleukin-1β
Time frame: Change from Baseline at 3 months
Interleukin-6
Time frame: Change from Baseline at 3 months
Interleukin-12
Time frame: Change from Baseline at 3 months
TGF-β1
Time frame: Change from Baseline at 3 months
Total Brain-derived neurotrophic factor
Time frame: Change from Baseline at 3 months
Free Brain-derived neurotrophic factor
Time frame: Change from Baseline at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based stress reduction in people with Late Life Depression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Che-min Lin, bachelor (0975366297, 8902008@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loneliness UCLA (time frame: Change from Baseline at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.