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

Sponsor
University of Deusto (Other)
Overall Status
Recruiting
CT.gov ID
NCT06028815
Collaborator
(none)
100
1
2
35
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Group music therapy
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents
Actual Study Start Date :
Jan 31, 2021
Actual Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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

  3. 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

  4. 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

  1. 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.

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Deusto Bilbao Bizkaia Spain 48007

Sponsors and Collaborators

  • University of Deusto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Deusto
ClinicalTrials.gov Identifier:
NCT06028815
Other Study ID Numbers:
  • NeuroemotionMusicCares
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Deusto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2023