Care BurdenMUSIC CARESNCT06028815
Group Music Therapy Intervention With Informal Carers of Elderly Dependents
A study testing Group music therapy in people with Care Burden and Anxiety, run by University of Deusto at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Care Burden, Anxiety, Depression
- What is being tested?
- Group music therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 31 Jan 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- not residing in Spain
- being under 18 years
- having uncompensated sensory deficits that prevented the administration of the assessment protocol;
- illiteracy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
University of Deusto
Bilbao, Bizkaia, 48007
Oscar Martínez, PhD., 944 13 90 00, oscar.martinez@deusto.es
About this study
Official title: Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents
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
- Being tested
- Group music therapy
- Keywords
- Group music therapy, Informal caregivers, Health-related quality of life (HRQOL), Anxiety, Depression
- Medical subject headings
- Caregiver Burden, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group music therapyBehavioural
Music therapy intervention using active and receptive techniques, focusing on the technique of songwriting.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Informal carers receive 10 music therapy sessions Receives: Behavioral: Group music therapy |
| Control group | No intervention | Informal carers do not receive music therapy sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start31 Jan 2021
- Primary completion1 Jan 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Care BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Deusto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028815
- Sponsor's protocol ID
- NeuroemotionMusicCares
- Acronym
- MUSIC CARES
- Status last verified
- Aug 2023
- First submitted
- 26 Jul 2023
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Group Music Therapy Intervention for Informal Caregivers of Elderly Dependents
- ClinicalTrials.gov ID
- NCT06028815
- Acronym / sponsor ID
- MUSIC CARES / NeuroemotionMusicCares
- Conditions
- Care Burden, Anxiety, Depression, Coping Strategies, Quality of Life
- Keywords
- Group music therapy, Informal caregivers, Health-related quality of life (HRQOL), Anxiety, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of DeustoUniversity, hospital or other
- Study start
- 31 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Group music therapyInformal carers receive 10 music therapy sessions |
| Control group | No intervention | –Informal carers do not receive music therapy sessions |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- not residing in Spain
- being under 18 years
- having uncompensated sensory deficits that prevented the administration of the assessment protocol;
- illiteracy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group music therapyMusic therapy intervention using active and receptive techniques, focusing on the technique of songwriting. | Behavioural | Experimental group |
Primary outcome
Health-related quality of life
Time frame: 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.
Anxiety Stay and Trait
Time frame: 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
Time frame: 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
Burden
Time frame: 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.
2 secondary outcomes
Coping strategies
Time frame: 3 months
Spirituality
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group music therapy in people with Care Burden and Anxiety, run by University of Deusto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.