Mental Health ImpairmentNCT06423092
Music Therapy Songwriting and Mental Health in Neonatel Intensive Care Unit (NICU) Parents
A study testing Music therapy songwriting in people with Mental Health Impairment, run by Claudia Aristizábal at 5 sites in 2 countries.
Trial summary
The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Impairment
- What is being tested?
- Music therapy songwriting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 30 Jul 2024to Jun 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The study population consisted of parents/caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization.
- Mother a total score of ≥10 and/or father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale)
- Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)
Who cannot join
- Parents/caregivers with known auditory problems that prevent participation in MT.
- Moreover parents/caregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments.
- Parents/caregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Colombia4 sites, 4 recruiting
- Recruiting
Clínica Iberoamérica en Colombia
Barranquilla, Atlántico
Mark Ettenberger, PhD, +57 605 3319424, mark.ettenberger@gmx.at
- Recruiting
Clinica Pediátrica
Bogotá, Cundinamarca
Mark Ettenberger, PhD, (+57) 601 745 5100, mark.ettenberger@gmx.at
- Recruiting
Clínica Universitaria Colombia
Bogotá, Cundinamarca
Mark Ettenberger, (+57) 6015948650, mark.ettenberger@gmx.at
Marcela Beltrán, MSc
- Recruiting
Clínica Keralty Ibagué
Ibague, Tolima Department
Mark Ettenberger, PhD, +57 60 1 646 6060, mark.ettenberger@gmx.at
Poland1 site, 1 recruiting
- Recruiting
University of Gdańsk
Gdansk
Łucja Bieleninik, PhD, +48 58 523 30 00, lucja.bieleninik@ug.edu.pl
Łucja Bieleninik, PhD
About this study
Official title: Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study.
The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.
The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.
Read the detailed description
This study employs a multicenter, mixed-method approach, with a quantitative component that will be a pragmatic parallel controlled randomized clinical trial (RCT) and a qualitative component that will include phenomenological study. The quantitative component will assess depression and anxiety, which will be evaluated with the Edinburgh Postnatal Depression Scale (EPDS) and the Generalized Anxiety Disorder Scale (GAD-7), respectively. Secondary outcomes will be resilience, coping, stress, and mental well-being. These outcomes will be measured in the first week of hospitalization (baseline measure) and then in weeks 1, 2, and 3 of the intervention. Changes in scores will be assessed to identify the effect, and mediating variables will be determined by multivariate analysis. Semi-structured interviews will be conducted on the parents' experience of music therapy songwriting for the baby.
The study will provide data on the effect of music therapy songwriting on the mental health of parents of neonates with brain injuries (PTNB) versus standard care and will document the lived experience of music therapy songs. The results may inform the standardization of this strategy in neonatal intensive care units (NICUs) to support and accompany parents and decrease the impact on their mental health.
- Conditions
- Mental Health Impairment
- Being tested
- Music therapy songwriting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapy songwritingOther
Session 1: The goal of the first music therapy session is to know the parents musically and to provide information about song creation. This is achieved by exploring their favorite songs. Options for creating a song (original song or song parody) are presented and possibilities for creating lyrics are discussed.
Sessions 2-7: The structure of the song will be created and discussed with the parents. Parents will also be invited to include written messages from other family members in the lyrics if they wish. In each session, the developing welcome song is sung together with the parents, accompanied by the music therapist, who provides vocal or instrumental support.
The final sessions (Sessions 8-9) are dedicated to singing the final version of the song with the parents and their infant. Should the parents desire, a final recording of the song will also be made and the digital songbook will be created.
| Study group | Role | What they receive |
|---|---|---|
| Music therapy songwriting + standard care | Experimental | The music therapy songwriting is a method frequently employed in music therapy sessions. This method involves the collaborative creation of lyrics and/or music with the participants. The intervention will consist of nine sessions, each of which will last approximately 30 to 45 minutes. Three sessions will be conducted per week until a minimum of six and a maximum of nine sessions are achieved. Receives: Other: Music therapy songwriting |
| Standard care | No intervention | Standard care is the usual care provided to parents of newborns hospitalized in a neonatal intensive care unit (NICU). This care includes providing information about the baby's health status and recommendations during contact with the baby. Additionally, when a health professional identifies symptoms of mental health disturbance in the parents, they are referred to a mental health professional for appropriate management. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum depression
Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS). This scale has values between 0 to 30 points. Higher scores mean a worse outcome.
Measured: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.
Secondary outcomes (5)
Anxiety
Anxiety will be assessed with the Generalized Anxiety Disorder Scale (GAD-7). Minimum and maximum possible scores of 0 and 21 respectively. Higher scores mean a worse outcome.
Measured: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
Well-being
The Warwick Edinburgh Mental Well-Being Scale (WEMWBS) will be employed to assess well-being. Minimum and maximum possible scores of 14 and 70 respectively. Higher scores mean a better wellbeing.
Measured: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
Resilience
Resilience will be assessed with the Brief Resilience Scale (BRS). Participants respond on a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree) and giving a range from 6-30. Higher scores mean a better resilience.
Measured: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Stress
Stress will be assessed with the 10-item Perceived Stress Scale (PSS-10). Answers are then scored on Likert scale from 0 "Never" to 4 "Very often". Higher scores indicate higher levels of perceived stress.
Measured: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Coping
Stress response will be assessed with the Brief COPE Inventory (Brief-COPE). Scores are presented on Likert scale from 1 " I haven't been doing this at all" to 4 "I've been doing this a lot".
Measured: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start30 Jul 2024
- Primary completionJan 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health ImpairmentStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Claudia Aristizábal
- Sponsor type
- University, hospital or other
- Collaborators
- Sanitas University
- Responsible party
- Sponsor-investigator, Claudia Aristizábal, Sanitas University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423092
- Sponsor's protocol ID
- 166-23 UNV
- Status last verified
- Sep 2024
- First submitted
- 15 May 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effectiveness of Music Therapy Songwriting on Mental Health Outcomes of At-risk Parents in the Neonatal Intensive Care Unit: an International Multicenter Mixed-methods Study.
- ClinicalTrials.gov ID
- NCT06423092
- Acronym / sponsor ID
- 166-23 UNV
- Conditions
- Mental Health Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Claudia AristizábalUniversity, hospital or other
- Collaborators
- Sanitas University
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 21 May 2024 (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.
The mental health of parents of preterm newborns (PTNB) is negatively affected by prolonged hospitalization of the PTNB in the intensive care unit. This produces changes in the role of the parents and the bond with the newborn, leading to states of depression, anxiety, and stress. Several strategies, including music therapy, have been implemented to mitigate the negative impact on the parents' mental health.
The main objectives of the proposed trial are to determine whether Music Therapy (MT) songwriting combined with standard care (SC) during NICU stay is superior to SC alone in reducing the risk of postpartum depression in at-risk parents of preterm children at the end of treatment, and understand the lived experiences of participating parents who received music therapy for their mental health.
Detailed description
This study employs a multicenter, mixed-method approach, with a quantitative component that will be a pragmatic parallel controlled randomized clinical trial (RCT) and a qualitative component that will include phenomenological study. The quantitative component will assess depression and anxiety, which will be evaluated with the Edinburgh Postnatal Depression Scale (EPDS) and the Generalized Anxiety Disorder Scale (GAD-7), respectively. Secondary outcomes will be resilience, coping, stress, and mental well-being. These outcomes will be measured in the first week of hospitalization (baseline measure) and then in weeks 1, 2, and 3 of the intervention. Changes in scores will be assessed to identify the effect, and mediating variables will be determined by multivariate analysis. Semi-structured interviews will be conducted on the parents' experience of music therapy songwriting for the baby.
The study will provide data on the effect of music therapy songwriting on the mental health of parents of neonates with brain injuries (PTNB) versus standard care and will document the lived experience of music therapy songs. The results may inform the standardization of this strategy in neonatal intensive care units (NICUs) to support and accompany parents and decrease the impact on their mental health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music therapy songwriting + standard care | Experimental | Other: Music therapy songwritingThe music therapy songwriting is a method frequently employed in music therapy sessions. This method involves the collaborative creation of lyrics and/or music with the participants. The intervention will consist of nine sessions, each of which will last approximately 30 to 45 minutes. Three sessions will be conducted per week until a minimum of six and a maximum of nine sessions are achieved. |
| Standard care | No intervention | –Standard care is the usual care provided to parents of newborns hospitalized in a neonatal intensive care unit (NICU). This care includes providing information about the baby's health status and recommendations during contact with the baby. Additionally, when a health professional identifies symptoms of mental health disturbance in the parents, they are referred to a mental health professional for appropriate management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The study population consisted of parents/caregivers of newborns hospitalized in neonatal intensive care units (NICUs) with gestational ages of ≤32 weeks and expected hospitalizations of at least three weeks. In the case of a twin pregnancy, the firstborn infant was randomly assigned to one of the intervention groups, while both infants received the same treatment according to the outcome of randomization.
- Mother a total score of ≥10 and/or father a total score of ≥7 on the EPDS (Edinburgh Postnatal Depression Scale)
- Mother and/or father a total score of ≥8 on the GAD-7 (Generalized Anxiety Disorder Scale)
Key exclusion criteria (3 listed)
- Parents/caregivers with known auditory problems that prevent participation in MT.
- Moreover parents/caregivers with a documented mental illness or cognitive impairment that prevents them from being able to complete the study intervention or outcome assessments.
- Parents/caregivers of premature infants in palliative or end-of-life care, infants with known hearing impairment, or infants in the custody of social services.
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 |
|---|---|---|
| Music therapy songwritingSession 1: The goal of the first music therapy session is to know the parents musically and to provide information about song creation. This is achieved by exploring their favorite songs. Options for creating a song (original song or song parody) are presented and possibilities for creating lyrics are discussed. Sessions 2-7: The structure of the song will be created and discussed with the parents. Parents will also be invited to include written messages from other family members in the lyrics if they wish. In each session, the developing welcome song is sung together with the parents, accompanied by the music therapist, who provides vocal or instrumental support. The final sessions (Sessions 8-9) are dedicated to singing the final version of the song with the parents and their infant. Should the parents desire, a final recording of the song will also be made and the digital songbook will be created. | Other | Music therapy songwriting + standard care |
Primary outcome
Postpartum depression
Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.
Postpartum depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS). This scale has values between 0 to 30 points. Higher scores mean a worse outcome.
5 secondary outcomes
Anxiety
Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
Well-being
Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 2 and 3 of the intervention.
Resilience
Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Stress
Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Coping
Time frame: It will be measured during the first week of hospitalization (baseline measurement) and at week 3 of the intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Related trials for Mental Health Impairment
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy songwriting in people with Mental Health Impairment, run by Claudia Aristizábal at 5 sites in 2 countries.
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 3 inclusion and 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Colombia, Poland. 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?
Contact Mark Ettenberger, PhD (+57 311 284 7635, mark.ettenberger@gmx.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postpartum depression (time frame: It will be measured during the first week of hospitalization (baseline measurement) and at weeks 1, 2, and 3 of the intervention.). 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 19 Sep 2024.