- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06919094
A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults (LSC Feasible)
A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults: A Mixed-Methods Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to explore the feasibility of a LSC© intervention to improve loneliness and apathy in community-dwelling older adults.
This pilot study will be conducted to compare loneliness and apathy in lonely individuals without dementia at baseline who receive a virtual group reminiscence therapy intervention (vGRT). The intervention will be delivered weekly over 12 weeks. Loneliness and apathy will be assessed before and after the intervention as described in the Outcome Measures section of this registration. Feasibility will be assessed using quantitative and qualitative measures including feasibility of screening and enrollment, acceptability, and program satisfaction. Qualitative interviews will be conducted with a subset of 30 individuals to explore acceptability, barriers, and facilitators of the intervention.
This study will provide evidence for the feasibility of a virtual group reminiscence therapy for community dwelling older adults to reduce loneliness and apathy. This approach is both innovative and pragmatic because it will leverage an existing community-based service, with an established infrastructure and track record within the community to deliver the intervention. As such, the proposed research has the potential for broad implications for community-based research and aligns with multiple translational science principles.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mirnova Ceide, MD
- Phone Number: 347-920-0112
- Email: mceide@montefiore.org
Study Locations
-
-
New York
-
The Bronx, New York, United States, 10467
- Recruiting
- Montefiore Medical Center
-
Contact:
- Mirnova Ceide, MD
- Phone Number: 347-920-0112
- Email: mceide@montefiore.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 60 and over
- English or Spanish fluency
- Able to provide informed consent
Exclusion Criteria:
- Dementia based on Aging and Dementia (AD8) score of ≥4 or previous dementia diagnosis
- Severe auditory or visual loss
- Lack of access to internet connection or phone
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Life Story Club
Virtual Group Reminiscence Therapy
|
Virtual group reminiscence therapy will be provided by the Life Story Club©.
Participants will meet virtually via Zoom© with their group (6-10 people) weekly for one hour over a 12-week period to exchange life stories and share in conversation.
Groups will be conducted in entirely in English or Spanish, based on participant preference.
Each week, the LSC© facilitator will guide the group with question prompts to encourage participants to share personal information, build friendships & rapport, and create a sense of community.
LSC© facilitators are trained in group interview techniques, technology management, and know how to respond appropriately to sensitive information that may emerge during group exchanges.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Loneliness
Time Frame: From baseline to 3 months and 6 months
|
Loneliness will be assessed using the University of California, Los Angeles (UCLA) Loneliness Scale questionnaire.
The UCLA Loneliness Scale is a 20-item measure that assesses how often a person feels disconnected from others.
Participants provide responses using a 4-point Likert scale where 1 = never; 2 = rarely; 3 = sometimes; 4 = always, for an overall possible scoring range of 20-80, such that higher scores are associated with increased loneliness.
Positively worded items in the questionnaire must be reverse-coded before reporting.
For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of an increase in loneliness from baseline and negative values a decrease in loneliness from baseline.
Group scores will be summarized using basic descriptive statistics.
|
From baseline to 3 months and 6 months
|
|
Change in Apathy
Time Frame: From baseline to 3 months and 6 months
|
Apathy will be assessed using the self-reported Apathy Evaluation Scale (AES-S).
The AES-S is an 18-item questionnaire that addresses characteristics of goal directed behavior that reflects apathy including behavioral, cognitive, and emotional indicators.
Participants provide responses based on a 4-point Likert scale where 1 = not at all true; 2 = slightly true; 3 = somewhat true; and 4 = very true, for an overall possible scoring range of 18-72, such that higher scores are associated with greater apathy.
Positively worded items in the scale must be reverse-coded before reporting.
For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased apathy from baseline and negative values decreased apathy from baseline.
Group scores will be summarized using basic descriptive statistics.
|
From baseline to 3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in cognition
Time Frame: From baseline to 3 months and 6 months
|
Cognition will be assessed using a version of the Telephone-Montreal Cognitive Assessment (T-MoCA).
The T-MoCA is a 22-item phone-administered exam which assesses a range of global cognitive domains including attention, memory, language, and orientation.
Each item is one point yielding an overall possible scoring range of 0-22, with higher scores being indicative of better cognitive function.
Scores of 18 or below are generally suggestive of Mild Cognitive Impairment (MCI).
For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased cognition from baseline and negative values decreased cognition from baseline.
Group scores will be summarized using basic descriptive statistics.
To reduce practice effect Version (V)8.1 will be administered at baseline, V8.2 at 3 months, and V8.3 at 6 months.
Scoring ranges are identical for all 3 versions.
|
From baseline to 3 months and 6 months
|
|
Change in Depressive Symptoms
Time Frame: From baseline to 3 months and 6 months
|
Depressive symptoms will be assessed by administration of the Geriatric Depression Scale - Short Form (GDS-15), The GDS-15 is a 15-item questionnaire in which participants provide a dichotomous (Yes/No) response as to how they have felt over the prior week.
Answers suggestive of depression are bolded/italicized on the questionnaire (may either be 'Yes' or 'No' depending on the item).
A score of 1 point is assigned for each bolded/italicized response such that higher scores are associated with more depressive symptoms.
A score of 0 to 5 is normal.
A score greater than 5 suggests depression.
For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increase in depressive symptoms from baseline and negative values a decrease in depressive symptoms from baseline.
Results will be summarized using basic descriptive statistics.
|
From baseline to 3 months and 6 months
|
|
Change in Meaning and Purpose
Time Frame: From baseline to 3 months and 6 months
|
Meaning and purpose will be assessed as a composite measure using the Patient-Reported Outcomes Measurement Information System (PROMIS) Meaning and Purpose 4-item scale.
The 4-item scale is designed to assess an individual's subjective experience of meaning and purpose in life.
Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 4-20, such that higher scores are associated with greater meaning and purpose.
For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased experiences of meaning and purpose from baseline and negative values decreased experiences of meaning and purpose from baseline.
Group results will be summarized using basic descriptive statistics
|
From baseline to 3 months and 6 months
|
|
Change in Social Support
Time Frame: From baseline to 3 months and 6 months
|
Social Support will be assessed using the Medical Outcomes Study (MOS) Social Support Scale.
The MOS is a 19-item multidimensional, self-administered instrument that measures the availability of support, if needed.
The overall social support component of the MOS Social Support scale will be used.
Participants provide responses on a 5-point Likert scale ranging from 1-5 for an overall possible scoring range of 19-95, such that higher scores are associated with greater availability of social support.
For purposes of this study changes from baseline to 3 months and baseline to 6 months will be assessed whereby positive values are indicative of increased social support and purpose from baseline and negative values decreased social support from baseline.
Group results will be summarized using basic descriptive statistics
|
From baseline to 3 months and 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mirnova Ceide, MD, Montefiore Medical Center
Publications and helpful links
General Publications
- Kirk M, Rasmussen KW, Overgaard SB, Berntsen D. Five weeks of immersive reminiscence therapy improves autobiographical memory in Alzheimer's disease. Memory. 2019 Apr;27(4):441-454. doi: 10.1080/09658211.2018.1515960. Epub 2018 Sep 8.
- Platel H, Eustache ML, Coppalle R, Viard A, Eustache F, Groussard M, Desgranges B. Boosting Autobiographical Memory and the Sense of Identity of Alzheimer Patients Through Repeated Reminiscence Workshops? Front Psychol. 2021 Feb 15;12:636028. doi: 10.3389/fpsyg.2021.636028. eCollection 2021.
- Allen AP, Doyle C, Roche RAP. The Impact of Reminiscence on Autobiographical Memory, Cognition and Psychological Well-Being in Healthy Older Adults. Eur J Psychol. 2020 May 29;16(2):317-330. doi: 10.5964/ejop.v16i2.2097. eCollection 2020 May.
- Choy JCP, Lou VWQ. Effectiveness of the Modified Instrumental Reminiscence Intervention on Psychological Well-Being Among Community-Dwelling Chinese Older Adults: A Randomized Controlled Trial. Am J Geriatr Psychiatry. 2016 Jan;24(1):60-69. doi: 10.1016/j.jagp.2015.05.008. Epub 2015 May 19.
- Cuevas PEG, Davidson PM, Mejilla JL, Rodney TW. Reminiscence therapy for older adults with Alzheimer's disease: A literature review. Int J Ment Health Nurs. 2020 Jun;29(3):364-371. doi: 10.1111/inm.12692. Epub 2020 Jan 26.
- Syed Elias SM, Neville C, Scott T. The effectiveness of group reminiscence therapy for loneliness, anxiety and depression in older adults in long-term care: a systematic review. Geriatr Nurs. 2015 Sep-Oct;36(5):372-80. doi: 10.1016/j.gerinurse.2015.05.004. Epub 2015 Jun 19.
- Saragih ID, Tonapa SI, Yao CT, Saragih IS, Lee BO. Effects of reminiscence therapy in people with dementia: A systematic review and meta-analysis. J Psychiatr Ment Health Nurs. 2022 Dec;29(6):883-903. doi: 10.1111/jpm.12830. Epub 2022 Apr 17.
- Lok N, Bademli K, Selcuk-Tosun A. The effect of reminiscence therapy on cognitive functions, depression, and quality of life in Alzheimer patients: Randomized controlled trial. Int J Geriatr Psychiatry. 2019 Jan;34(1):47-53. doi: 10.1002/gps.4980. Epub 2018 Sep 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-16787
- UM1TR004400 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Loneliness
-
Education University of Hong KongRecruiting
-
Education University of Hong KongThe University of Hong KongRecruiting
-
University College, LondonUniversity of Manchester; National Academy for Social Prescribing; We Do WellbeingActive, not recruiting
-
University of RochesterNational Institute on Aging (NIA)Completed
-
Vladimíra DostálováBarcelona Institute for Global HealthActive, not recruiting
-
University College, LondonUniversity of ManchesterActive, not recruiting
-
Taipei Medical UniversityCompleted
-
Linkoeping UniversityUniversity College, LondonCompleted
-
KTO Karatay UniversityCompleted
Clinical Trials on Life Story Club
-
Texas Tech University Health Sciences CenterTexas Tech UniversityRecruiting
-
University of HoustonCompletedQuality of Life | Depressive SymptomsUnited States
-
Tung Wah CollegeUnknownHome Caregiver-older Adults Relationship
-
Cara J. HamannEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedAdolescent | Attitudes | Education | Self Efficacy | Behavior | Safety | Knowledge | Practice | BicyclingUnited States
-
Jennifer AccardoAmerican Academy of Sleep MedicineCompletedChild | Developmental Disabilities | Sleep Disorders | Polysomnography | Preparation for Medical ProcedureUnited States
-
Milton S. Hershey Medical CenterFirst Affiliated Hospital of Heilongjiang Chinese Medicine UniversityCompleted
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH); Aurum InstituteCompletedHiv | Adherence, PatientSouth Africa
-
Paris Translational Research Center for Organ TransplantationRecruiting
-
University of MinnesotaNational Heart, Lung, and Blood Institute (NHLBI); University of North Carolina... and other collaboratorsCompleted
-
ANRS, Emerging Infectious DiseasesKappa Santé; CerballianceCompleted