- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04076670
A Psychological Intervention for Family Caregivers of Palliative Care Patients
Benefits of a Psychological Intervention in Family Caregivers of Palliative Care Patients
This work aims to study the benefits a psychological intervention in family caregivers of palliative care patients can have for reducing anxiety, depression and overburden.
A parallel randomized controlled trial of two groups was performed. Information was collected on 154 family caregivers of patients at the end of life during the moments before and after the intervention.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Valencia, Spagna, 46010
- Universitat de València
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- To be the main family caregiver of a patient at the end of life, receiven palliative care. In the present study, the main family caregiver is defined as follows: family member who assumes the main tasks of care and attends to the patient most of the time, or for a longer period of time than other members of the family.
- To have signed the informed consent.
Exclusion Criteria:
• To present cognitive impairment.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Control group
Group pf participants that received usual psychological attention.
|
|
|
Sperimentale: Experimental group
Group of participants that received usual psychological attention plus the structured psychological intervention prosed in the study.
|
The intervention protocol is a structured programme within the framework of counselling, that aims to reduce anxiety and depression symptoms, as well as symptoms of burden (overburden).
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in anxiety (PRE and POST measures)
Lasso di tempo: Baseline up to 3 months
|
This variable was assesed with the Hospital Anxiety and Depression Scale, HADS. This Scale contains 7 items asessing anxiety, where lower values represent a better outcome. In order to observe the change in anxiety, it was measured at two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out. Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study. |
Baseline up to 3 months
|
|
Change in depression (PRE and POST measures)
Lasso di tempo: Baseline up to 3 months
|
This variable was assesed with the Hospital Anxiety and Depression Scale, HADS. In order to observe the change in depression, it was measured at two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out. Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study. |
Baseline up to 3 months
|
|
Change in burden (PRE and POST measures)
Lasso di tempo: Baseline up to 3 months
|
This variable was assesed with the Zarit Burden Inventory. In order to observe the change in burden, it was measured at two time points: First measurement: PRE. Once the participant had signed the informed consent, the initial score for this outcome was assessed. Second measurement: POST. Up to 3 months after the first measurement the second measurement of the same variable was carried out. Between first and second measurement, the control group received the usual psychological attention, whereas the intervention group received the usual psychological attention plus the structured psychological intervention proposed in this study. |
Baseline up to 3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Pilar Barreto Martin, PhD, Universitat de València
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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
Altri numeri di identificazione dello studio
- PSI2010-19426
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
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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 .