- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07543653
Evaluering af effektiviteten af interventioner til at reducere ensomhed blandt yngre voksne i Hong Kong
Gruppebaseret positiv affekt-intervention til reduktion af ensomhed: Et randomiseret kontrolleret forsøg med unge voksne i Hongkong
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Ensomhed blandt unge voksne er blevet et stigende folkesundhedsproblem, forbundet med depression, angst, lavt selvværd og reduceret livstilfredshed.\nI modsætning til ældre voksne, hvis ensomhed ofte er knyttet til social isolation, formes ensomhed i ung voksenliv af udviklingsmæssige overgange, skiftende relationsbehov og øget følsomhed over for social vurdering.\nEksisterende interventioner retter sig primært mod ældre befolkninger og adresserer ofte ikke de følelsesmæssige og kognitive processer, der er centrale for ensomhed hos yngre grupper.<\/p>
Denne undersøgelse adresserer disse huller ved at anvende en multi-teoretisk ramme, der integrerer det sociale behovsperspektiv, Weiss' multidimensionelle teori, den kognitive discrepancy model og reaffilieringsmotivmodellen.\nSammen konceptualiserer disse perspektiver ensomhed som opstået fra uopfyldte behov for meningsfuld forbindelse, uoverensstemmelser mellem ønskede og faktiske relationer samt maladaptive kognitive og adfærdsmæssige reaktioner, der hæmmer genforbindelse.<\/p>
Undersøgelsen anvender et to-armet randomiseret kontrolleret forsøgsdesign.\nI alt 110 universitetsstuderende i Hong Kong, der rapporterer forhøjet ensomhed, vil blive rekrutteret og screenet ved hjælp af UCLA Loneliness Scale.\nBerettigede deltagere vil blive tilfældigt tildelt enten den gruppebaserede Positive Affect (PA) intervention eller den gruppebaserede Social Skills Training (SST) aktive kontrolbetingelse.\nBegge interventioner vil blive leveret i fire ugentlige gruppesessioner på 60-75 minutter.<\/p>
PA interventionen er forankret i Broaden-and-Build teorien og revideret stress- og coping teori.\nDen benytter en multi-færdighedstilgang til at forbedre positive følelser gennem praksisser som at nyde positive begivenheder, taknemmelighed, mindfulness, positiv revurdering, identifikation af styrker, målsætning og venlighedshandlinger.\nDisse færdigheder forventes at øge positiv affekt, fremme socialt engagement og styrke psykologiske ressourcer, hvilket reducerer ensomhed.<\/p>
SST interventionen fungerer som en aktiv kontrol og fokuserer på at forbedre interpersonel kompetence.\nDen inkluderer træning i social adfærdsstile (selvsikker, genert, aggressiv), at indlede og opretholde sociale interaktioner, sætte grænser, give og modtage feedback samt konfliktløsning.\nForbedringer i interpersonel kompetence forventes at øge oplevet social støtte, hvilket igen reducerer ensomhed.<\/p>
Primære resultater vil blive vurderet ved hjælp af UCLA Loneliness Scale, med yderligere målinger, der fanger positiv affekt, oplevet social støtte, social netværksdiskrepans, mindfulness, følelsesregulering, self-efficacy og afvisningsfølsomhed.\nData vil blive indsamlet ved baseline og ved opfølgninger efter 1 og 3 måneder.\nLineære mixed-effects modeller vil blive brugt til at undersøge interventionseffekter over tid, mens meditations- og modereret meditationsanalyser vil teste de foreslåede mekanismer.<\/p>
En central innovation i denne undersøgelse ligger i dens undersøgelse af mekanismer.\nPositiv affekt og oplevet social støtte antages som mediatorer, der afspejler følelsesmæssige og relationelle veje til ensomhedsreduktion.\nAfvisningsfølsomhed modelleres som en moderator, der påvirker både, hvordan deltagere reagerer på interventionen, og hvordan gevinster omsættes til reduceret ensomhed.\nPersoner med høj afvisningsfølsomhed kan vise svagere interventionseffekter på grund af øget trusselsopfattelse og tendens til social tilbagetrækning.<\/p>
Denne forskning bidrager til både teori og praksis ved at teste en udviklingsmæssigt passende, mekanismedrevet intervention for unge voksne.\nDet fremmer forståelsen af, hvordan følelsesmæssige og sociale processer interagerer i ensomhedsreduktion, og giver evidens for skalerbare, gruppebaserede interventioner, der kan implementeres i universitets- og samfundsmæssige sammenhænge.<\/p>"
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: JIN ZHANG
- Telefonnummer: 85229487138
- E-mail: s1151958@s.eduhk.hk
Studiesteder
-
-
Hong Kong
-
Hong Kong, Hong Kong, Hong Kong
- Rekruttering
- The Education University of Hong Kong
-
Kontakt:
- JIN ZHANG
- Telefonnummer: 85229487138
- E-mail: s1151958@s.eduhk.hk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- alder 18 til 30 år
- færdigheder i kantonesisk
- oplever ensomhed (defineret som en score på ≥ 6 på 3-punkts UCLA Loneliness Scale)
Eksklusionskriterier:
- kognitive svækkelser
- psykiatriske lidelser, indlæringsvanskeligheder eller aktiv selvmordstanker
- i øjeblikket deltager i anden psykoterapi eller psykosociale interventioner med henblik på at forbedre velvære
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group-based Social Skills Training
Participants in the Social Skills Training (SST) group will receive a group-based SST intervention as an active control.
|
The SST intervention serves as an active control and focuses on improving interpersonal competence.
It includes training in social behavior styles (assertive, shy, and aggressive), initiating and maintaining social interactions, setting boundaries, giving and receiving feedback, and conflict resolution.
Improvements in interpersonal competence are expected to enhance perceived social support, which in turn reduces loneliness.
The intervention will be delivered over a 4-week period.
|
|
Eksperimentel: Group-based Positive Affect Intervention
Participants in the Positive Affect (PA) group will receive a group-based psychoeducation intervention designed to test its effectiveness in reducing loneliness among college students.
|
This 4-week intervention consists of eight skills aimed at enhancing positive affect, delivered via group-based psychoeducation by trained facilitators.
Participants will learn skills such as gratitude, mindfulness, and positive reappraisal, with sessions held once a week to test the effects of the intervention in reducing loneliness among young adults.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Loneliness measured by the University of California, Los Angeles (UCLA) Loneliness Scale
Tidsramme: Baseline, 1-month, and 3-month
|
The UCLA Loneliness Scale is a reliable self-assessment tool designed to evaluate subjective feelings of loneliness. Total scores are calculated based on individual item ratings ranging from 1 (never) to 4 (always). Higher scores indicate a greater degree of loneliness (worse outcome). |
Baseline, 1-month, and 3-month
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Perceived Stress on the Perceived Stress Scale (PSS-10)
Tidsramme: Baseline, 1-month, and 3-month
|
The Chinese version of the Perceived Stress Scale is a validated self-report tool used to measure the degree to which situations in one's life are appraised as stressful. Individual items are rated on a scale from 0 (never) to 4 (very often). Higher scores indicate higher levels of perceived stress (worse outcome). |
Baseline, 1-month, and 3-month
|
|
Symptoms of Depression on the Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: Baseline, 1-month, and 3-month
|
The Patient Health Questionnaire-9 is a reliable self-report measure designed to evaluate the severity of depressive symptoms over the past two weeks. Possible scores for each item range from 0 (not at all) to 3 (nearly every day). Higher scores indicate more severe symptoms of depression (worse outcome). |
Baseline, 1-month, and 3-month
|
|
Symptoms of Anxiety on the Generalized Anxiety Disorder-7 (GAD-7) Scale
Tidsramme: Baseline, 1-month, and 3-month
|
The Chinese version of the Generalized Anxiety Disorder-7 Scale is a validated, self-reported instrument assessing the severity of anxiety symptoms. Possible scores for each item range from 0 (not feeling at all) to 3 (most of the time).Higher scores indicate more severe symptoms of anxiety (worse outcome). |
Baseline, 1-month, and 3-month
|
|
Perceived Social Support on the Multidimensional Scale of Perceived Social Support (MSPSS)
Tidsramme: Baseline, 1-month, and 3-month
|
The Multidimensional Scale of Perceived Social Support evaluates the social support derived from three key sources: family, friends, and significant others. Respondents rate each item on a 7-point Likert scale, where 1 represents "very strongly disagree" and 7 indicates "very strongly agree." Higher scores indicate a higher level of perceived social support (better outcome). |
Baseline, 1-month, and 3-month
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Affective Experience over the Past Week on the 30-item Affect Valuation Index (AVI)
Tidsramme: Baseline, 1-month, and 3-month
|
The Affect Valuation Index (AVI) is a validated, self-reported instrument assessing affective experiences over the past week. It evaluates the frequency of actual emotions experienced. Possible scores for each emotion item range from 1 (very slightly or not at all) to 5 (extremely or all the time). Higher scores indicate a greater frequency of that specific affective state. (Note: High scores in positive affect represent a better outcome, while high scores in negative affect represent a worse outcome). |
Baseline, 1-month, and 3-month
|
|
Meaning of Life on 7-point Meaning in Life Questionnaire (MLQ)
Tidsramme: Baseline, 1-month, and 3-month
|
The Meaning in Life Questionnaire (MLQ) is a reliable self-assessment tool that evaluates an individual's sense of meaning in life across two subscales: Presence of Meaning and Search for Meaning. Each subscale (5 items each) has a minimum score of 5 and a maximum score of 35. Higher scores on the Presence subscale indicate a stronger sense that life is meaningful. Higher scores on the Search subscale indicate a greater drive to find meaning. |
Baseline, 1-month, and 3-month
|
|
Gratitude on 7-point Gratitude Scale Questionnaire-Six Item Form (GQ-6)
Tidsramme: Baseline, 1-month, and 3-month
|
The Gratitude Questionnaire-Six Item Form (GQ-6) is a validated self-report measure that evaluates the inclination to recognize and respond to life events with gratitude. Total scores range from 6 (strongly disagree across all items) to 42 (strongly agree across all items). Higher scores indicate a higher level of dispositional gratitude (better outcome). |
Baseline, 1-month, and 3-month
|
|
Mindfulness on the 5-point Five Facet Mindfulness Questionnaire (FFMQ)
Tidsramme: Baseline, 1-month, and 3-month
|
The Five Facet Mindfulness Questionnaire (FFMQ) is a validated measure assessing five different elements of mindfulness in daily life. Responses are scored on a scale from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate higher levels of mindfulness (better outcome). |
Baseline, 1-month, and 3-month
|
|
Cognitive Reappraisal on the 7-point Emotion Regulation Questionnaire (ERQ)
Tidsramme: Baseline, 1-month, and 3-month
|
The Emotion Regulation Questionnaire (ERQ) is a validated instrument assessing strategies used to manage emotions, specifically Cognitive Reappraisal and Expressive Suppression. Items are rated from 1 (strongly disagree) to 7 (strongly agree). The Reappraisal subscale (6 items) ranges from 6 to 42. Higher scores on Cognitive Reappraisal indicate more frequent use of adaptive emotional regulation (better outcome). |
Baseline, 1-month, and 3-month
|
|
Self-Efficacy on the 4-point General Self-Efficacy Scale (GSE)
Tidsramme: Baseline, 1-month, and 3-month
|
The General Self-Efficacy Scale (GSE) measures an individual's optimistic beliefs regarding their capacity to manage challenging situations and cope with stressors. This 10-item scale ranges from a total minimum of 10 to a maximum of 40 (based on a 1-4 Likert scale). Higher scores indicate a stronger belief in one's own self-efficacy (better outcome). |
Baseline, 1-month, and 3-month
|
|
Interpersonal Competence on the 15-item Interpersonal Competence Questionnaire (ICQ-15)
Tidsramme: Baseline, 1-month, and 3-month
|
The 15-item Interpersonal Competence Questionnaire (ICQ-15) assesses self-reported proficiency across five social domains, including initiating relationships and conflict management. It is using a 4-point Likert-type scale, where 1 indicates "I'm always poor at this" and 4 represents "I'm always good at this." Total scores range from 15 to 60. Higher scores indicate a higher level of interpersonal proficiency and social skill (better outcome). |
Baseline, 1-month, and 3-month
|
|
Rejection Sensitivity on the Adult Rejection Sensitivity Questionnaire (A-RSQ)
Tidsramme: Baseline, 1-month, and 3-month
|
The Adult Rejection Sensitivity Questionnaire (A-RSQ) assesses cognitive-affective processing styles regarding the expectation of social rejection. Scores are calculated based on concern and likelihood of rejection across 15 items, with total scores typically ranging from 1 to 36 (mean score). Higher scores indicate a greater sensitivity to and anxious expectation of social rejection (worse outcome). |
Baseline, 1-month, and 3-month
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2024-2025-0467
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Group-based Positive Affect Intervention
-
Washington University School of MedicineSpinal Cord Injury/Disease Research ProgramAfsluttet
-
The Policy & Research GroupDepartment of Health and Human Services; Mathematica Policy Research, Inc.AfsluttetForebyggelse af teenagegraviditetForenede Stater
-
Albert Einstein College of MedicineHealth Resources and Services Administration (HRSA); The New SchoolAfsluttetVold i hjemmet | BørnemishandlingForenede Stater
-
National Healthcare Group PolyclinicsInstitute of Mental Health, Singapore; Lee Kong Chian School of Medicine... og andre samarbejdspartnereIkke rekrutterer endnuMentalt helbred | Trivsel/LivskvalitetSingapore
-
Medipol UniversityAfsluttetHyperkyfose | Kyphose ThoracicKalkun
-
University of PaviaUniversità degli Studi di BresciaAfsluttetMentalt velværeItalien
-
Stockholm UniversityKarolinska Institutet; Region Stockholm; Centrum för kompetensutveckling... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
Swiss Paraplegic Research, NottwilAfsluttetKronisk smerte | RygmarvsskadeSchweiz
-
University of Illinois at Urbana-ChampaignRosenfeld Heart Foundation GrantUkendtKardiovaskulær risikofaktor | Ukontrolleret hypertensionForenede Stater