Group Music Therapy Intervention With Informal Carers of Elderly Dependents (MUSIC CARES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Quality of Life; Anxiety; Care Burden; Coping Strategies
• Intervention / Treatment: Behavioral: Group music therapy

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48007
      • Recruiting
      • University of Deusto
      • Contact: Oscar Martínez, PhD.; Phone Number: 944 13 90 00; Email: oscar.martinez@deusto.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Informal carers receive 10 music therapy sessions	Behavioral: Group music therapy; Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.
No Intervention: Control group; Informal carers do not receive music therapy sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Deusto

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 26, 2023
• First Submitted That Met QC Criteria: August 31, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 31, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Anxiety; Informal caregivers; Group music therapy; Health-related quality of life (HRQOL)
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: NeuroemotionMusicCares

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data is available from now until 2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No