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En virtuell livshistoria klubbinsats för att förbättra ensamhet och apati hos äldre vuxna i samhället (LSC Feasible)

22 september 2026 uppdaterad av: Montefiore Medical Center

En virtuell livshistoria klubbintervention för att förbättra ensamhet och apati hos äldre vuxna i samhället: en genomförbarhetsstudie med blandade metoder

Reminiscence therapy is a non-invasive, non-pharmacological intervention that has been shown to improve cognition, mood, functional status, quality of life, and apathy in older adults. Group reminiscence therapy combines structured social engagement and recounting of personal stories that address both social connection (a risk factor for cognitive decline) and cognition. Life story club© (LSC) is an established, non-profit organization that provides virtual, group reminiscence therapy for older adults to reduce loneliness and promote a sense of belonging and has not been formally studied.

Studieöversikt

Status

Rekrytering

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • New York
      • The Bronx, New York, Förenta staterna, 10467
        • Rekrytering
        • Montefiore Medical Center
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

60 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in Loneliness
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in cognition
Tidsram: 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 Meaning and Purpose
Tidsram: 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 Depressive Symptoms
Tidsram: 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 Social Support
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Mirnova Ceide, MD, Montefiore Medical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 augusti 2025

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

26 mars 2025

Först inskickad som uppfyllde QC-kriterierna

2 april 2025

Första postat (Faktisk)

9 april 2025

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

25 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • 2025-16787
  • UM1TR004400 (U.S.S. NIH-anslag/kontrakt)
  • 2025 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

OBESLUTSAM

IPD-planbeskrivning

Data sharing to be determined.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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