NCT05620511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 17, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 17, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

November 7, 2022

Last Update Submit

November 14, 2022

Conditions

Late Life Depression

Keywords

elderly depressionMindfulness-based stress reduction (MBSR)MRIautonomic nervous system

Outcome Measures

Primary Outcomes (3)

  • Loneliness UCLA

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

    Change from Baseline at 3 months

  • Mindfulness

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

    Change from Baseline at 3 months

  • Ham D-17

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

    Change from Baseline at 3 months

Secondary Outcomes (9)

  • Verbal Learning & Memory

    Change from Baseline at 3 months

  • structural and functional connectivity

    Change from Baseline at 3 months

  • Interleukin-1α

    Change from Baseline at 3 months

  • Interleukin-1β

    Change from Baseline at 3 months

  • Interleukin-6

    Change from Baseline at 3 months

  • +4 more secondary outcomes

Study Arms (2)

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

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

Behavioral: Mindfulness based stress reduction

Interventions

Mindfulness based stress reductionBEHAVIORAL

Mindfulness based stress reduction v.s.Relaxation

Mindfulness based stress reductionRelaxation

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Che-min Lin

Keelung, 204, Taiwan

RECRUITING

MeSH Terms

Interventions

Mindfulness-Based Stress Reduction

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Che-min Lin, bachelor

CONTACT

09753662978902008@cgmh.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

November 17, 2022

Study Start

August 1, 2020

Primary Completion

December 4, 2020

Study Completion

July 31, 2023

Last Updated

November 17, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)