Group Music Therapy Intervention With Informal Carers of Elderly Dependents

Depression Clinical Trial

— MUSIC CARES  

Official title:

Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028815
• Other study ID #: NeuroemotionMusicCares
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: University of Deusto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the effects of a group music therapy intervention with informal caregivers of elderly people on clinical psychological symptoms, taking into account variables such as caregiver burden, anxiety and depression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• to be the main informal caregiver of an elderly dependant
• the dependant person has to be over 60 years of age
• to be over 18 years of age
• having signed the informed consent form accepting the assessment and intervention

Exclusion Criteria:

• not residing in Spain
• being under 18 years
• having uncompensated sensory deficits that prevented the administration of the assessment protocol;
• illiteracy.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Quality of Life

Intervention

Behavioral:
• Group music therapy
Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.

Locations

Country	Name	City	State
Spain	University of Deusto	Bilbao	Bizkaia

Sponsors (1)

Lead Sponsor	Collaborator
University of Deusto

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life	For evaluating Health-Related Quality of Life is going to use the 36-Item Short Form Health Survey questionnaire (SF-36).; The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS).; The correct calculation of SF-36 summary measures PCS and MCS requires the use of special algorithms.; The scores obtained in this questionnaire range from 0 to 100, with 0 being the worst state of health and 100 the best state of health for the dimension assessed. Thus, the higher the score obtained, the better the quality of life of the person assessed.	3 months
Primary	Anxiety Stay and Trait	The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety that also is often used in research as an indicator of caregiver distress.; It has 20 items for assessing trait anxiety and 20 for state anxiety, on a 4-point Likert scale.; Scores range from 20 to 80, with higher scores correlating with greater anxiety	3 months
Primary	Depression	Assessed with the BDI-II that contains 21 items and identifies symptoms and attitudes associated with depression.; Each item is evaluated on a severity scale ranging from 0-3, with a total score ranging from 0-63.; Higher total scores indicate more severe depressive symptoms	3 months
Primary	Burden	To assess the burden, it is using the Burden Zarit Interview that is a self-report instrument that assesses the level of caregiver burden. It consists of 22 items that are assessed using a Likert-type scale, where higher scores indicate greater burnout.	3 months
Secondary	Coping strategies	Coping strategies are evaluated with the COPE-28 that is the brief version inventory of 28 items and 14 subscales that is applied on an ordinal Likert-type scale with four response alternatives (from 0 to 3) between "I never do this" and "I always do this", with intermediate scores.	3 months
Secondary	Spirituality	The outcome spirituality is assessed with the WHOQOL-SRPB,a 32-item instrument that measures spiritual, religious, and personal beliefs in 8 dimensions. Each item has a 5-point Likert format for responses from 1 ("not at all") to 5 ("completely").; The WHOQOL-SRPB total score ranges from 0 to 100, with higher scores indicating higher spirituality.	3 months