Group Music Therapy Intervention With Informal Carers of Elderly Dependents

Not Applicable

Recruiting

• Conditions: Anxiety; Quality of Life; Care Burden; Depression; Coping Strategies
• Interventions: Behavioral: Group music therapy

• Registration Number: NCT06028815
• Lead Sponsor: University of Deusto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-31
• Primary Completion: 2022-01-01
• Study First Submitted: 2023-07-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-31
• Last Update Submitted: 2023-08-31
• Study First Posted: 2023-09-08
• Last Update Posted: 2023-09-08
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Group music therapy	Informal carers receive 10 music therapy sessions

Primary Outcome Measures

Name	Time	Method
Anxiety Stay and Trait	3 months	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	3 months	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
Health-related quality of life	3 months	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.
Burden	3 months	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

Name	Time	Method
Coping strategies	3 months	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	3 months	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.

Trial Locations

Locations (1)

University of Deusto; 🇪🇸 Bilbao, Bizkaia, Spain