Group Music Therapy Intervention With Informal Carers of Elderly Dependents

NCT06028815 | Unknown

• 1 other identifier: NeuroemotionMusicCares
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Care Burden; Anxiety; Depression; Coping Strategies; Quality of Life

Keywords

Group music therapy; Informal caregivers; Health-related quality of life (HRQOL); Anxiety; Depression

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Coping strategies

  3 months

• Spirituality

  3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Informal carers receive 10 music therapy sessions

Behavioral: Group music therapy

Control group

NO INTERVENTION

Informal carers do not receive music therapy sessions

Interventions

Group music therapy BEHAVIORAL

Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.

Experimental group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Deusto: lead

Study Sites (1)

University of Deusto

Bilbao, Bizkaia, 48007, Spain

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: September 8, 2023
• Study Start: January 31, 2021
• Primary Completion: January 1, 2022
• Study Completion: December 31, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data is available from now until 2025

Locations

ES (1)