Group Music Therapy Intervention With Informal Carers of Elderly Dependents

Study Overview
=================
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.

Official Title
-----------------
Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents

Conditions
-----------------
Quality of Life, Care Burden, Anxiety, Depression, Coping Strategies

Intervention / Treatment
-----------------
* Behavioral: Group music therapy


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Informal carers receive 10 music therapy sessions | Behavioral: Group music therapy<br>* Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.<br>|
| No Intervention: Control group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Group music therapy, Informal caregivers, Health-related quality of life (HRQOL), Anxiety, Depression