- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07714408
The Effects of a Smartphone-Based Acceptance and Commitment Therapy Program on the Mental Health and Quality of Life of Caregivers Working in Long-Term Care Facilities
The Effects of a Smartphone-Based Acceptance and Commitment Therapy Program on the Mental Health and Quality of Life of Caregivers Working in Long-Term Care Facilities: A Randomized Controlled Trial Study
The aim of this study is to investigate whether a smartphone-based Acceptance and Commitment Therapy (ACT) program can improve the mental health and quality of life of care workers in long-term care facilities. The research question of this study is as follows: Among caregivers working in long-term care facilities, are there differences in mental health, quality of life, and job burnout between the experimental group that participated in a smartphone-based ACT program and the control group that participated in a document-based ACT program?
Participants in the experimental group will complete 70 daily sessions of a smartphone-based ACT program using Anzeilax-Plus, administered Monday through Friday over a 14-week period. Participants in the control group will complete 70 daily assignments from a document-based ACT program, administered Monday through Friday over the same 14-week period.
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Woosang Hwang, Ph.D.
- Numero di telefono: 82-2-2077-7380
- Email: woosanghwang@sookmyung.ac.kr
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Caregivers aged 18 years or older who provide care services to older adults in long-term care facilities, own a smartphone, and have no history of depression or other mental illnesses.
Exclusion Criteria:
- Caregivers with a history of depression or other mental illnesses, or those who do not own a smartphone.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Mobile-based ACT group
One daily session of the smartphone-based ACT program delivered through the Anzeilax-Plus app
|
Participants will complete a daily Acceptance and Commitment Therapy (ACT) session through a mobile application on their smartphones.
|
|
Comparatore attivo: Document-based ACT group
One daily session of the document-based ACT program
|
Participants will complete a daily Acceptance and Commitment Therapy (ACT) session using materials provided by the research team.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Depressive symptoms
Lasso di tempo: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Depressive symptoms will be measured using the Patient Health Questionnaire-9, a 9-item self-report measure.
Each item is rated on a 4-point scale, with total scores ranging from 9 to 36.
Higher scores indicate higher levels of depressive symptoms.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Anxiety
Lasso di tempo: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Anxiety will be measured using the Generalized Anxiety Disorder-7, a 7-item self-report measure.
Each item is rated on a 4-point scale, with total scores ranging from 7 to 28.
Higher scores indicate higher levels of anxiety.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Stress
Lasso di tempo: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Stress will be measured using the Perceived Stress Scale-10, a 10-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 10 to 50.
Higher scores indicate higher levels of stress.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Self-esteem
Lasso di tempo: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Self-esteem will be measured using the Rosenberg Self-Esteem Scale, a 10-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 10 to 50.
Higher scores indicate higher levels of self-esteem
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Job burnout
Lasso di tempo: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Job burnout will be measured using the Maslach Burnout Inventory-General Survey, a 15-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 15 to 75.
Higher scores indicate higher levels of job burnout.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
|
Quality of life (Psychological and physical well-being)
Lasso di tempo: From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Quality of life will be measured using the World Health Organization Quality of Life Scale a 15-item self-report measure.
Each item is rated on a 5-point scale, with total scores ranging from 15 to 75.
Higher scores indicate higher levels of quality of life.
|
From enrollment to Week 7 (mid-intervention) and Week 14 (end of the intervention)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SMWU-2604-HR-020-01
- RS-2026-25477485 (Altro numero di sovvenzione/finanziamento: National Research Foundation of Korea)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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