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

Primary Purpose

Care Burden, Anxiety, Depression

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Group music therapy
Sponsored by
University of Deusto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Care Burden focused on measuring Group music therapy, Informal caregivers, Health-related quality of life (HRQOL), Anxiety, Depression

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of DeustoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Informal carers receive 10 music therapy sessions

Informal carers do not receive music therapy sessions

Outcomes

Primary Outcome Measures

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.
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
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
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
July 26, 2023
Last Updated
August 31, 2023
Sponsor
University of Deusto
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1. Study Identification

Unique Protocol Identification Number
NCT06028815
Brief Title
Group Music Therapy Intervention With Informal Carers of Elderly Dependents
Acronym
MUSIC CARES
Official Title
Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 31, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Deusto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Care Burden, Anxiety, Depression, Coping Strategies, Quality of Life
Keywords
Group music therapy, Informal caregivers, Health-related quality of life (HRQOL), Anxiety, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Informal carers receive 10 music therapy sessions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Informal carers do not receive music therapy sessions
Intervention Type
Behavioral
Intervention Name(s)
Group music therapy
Intervention Description
Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.
Primary Outcome Measure Information:
Title
Health-related quality of life
Description
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.
Time Frame
3 months
Title
Anxiety Stay and Trait
Description
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
Time Frame
3 months
Title
Depression
Description
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
Time Frame
3 months
Title
Burden
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Coping strategies
Description
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.
Time Frame
3 months
Title
Spirituality
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Deusto
City
Bilbao
State/Province
Bizkaia
ZIP/Postal Code
48007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Martínez, PhD.
Phone
944 13 90 00
Email
oscar.martinez@deusto.es

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
The data is available from now until 2025

Learn more about this trial

Group Music Therapy Intervention With Informal Carers of Elderly Dependents

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