High-frequency vs low-frequency music therapy in psychiatric inpatients
| ISRCTN | ISRCTN87861817 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87861817 |
- Submission date
- 15/10/2024
- Registration date
- 21/11/2024
- Last edited
- 13/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
This study is comparing two different schedules of music therapy for patients with mental health disorders. It aims to find out if having music therapy sessions more frequently (five times a week) is more effective than having them less frequently (once a week) in reducing symptoms of anxiety, depression, and stress, and in improving overall life satisfaction.
Who can participate?
Adults who have been hospitalized in a mental health unit for at least 48 hours and have recently had their medication adjusted can participate in this study.
What does the study involve?
Participants will be randomly assigned to one of two groups: one group will have music therapy sessions five times a week, and the other group will have sessions once a week. The therapy sessions include activities like Progressive Muscle Relaxation and using various musical instruments and tools to encourage creativity and relaxation. Participants will complete questionnaires about their symptoms before and after the therapy.
What are the possible benefits and risks of participating?
The possible benefits include reduced symptoms of stress, anxiety, and depression. However, there are some risks, such as the therapy potentially bringing up negative memories, creating a sense of strangeness, or causing mental fatigue due to the repetition of sessions.
Where is the study run from?
The study is being conducted at ICSN - Clínica Montserrat in Bogotá, Colombia
When is the study starting and how long is it expected to run for?
July 2024 to September 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Manuel-F Esteban-Cárdenas, mestebanc@unbosque.edu.co
Contact information
Principal Investigator
Carrera 53 #134a-47 Bogotá.Colombia
806
Bogota D.C
111111
Colombia
 ORCID ID |
0000-0002-8516-6151 |
|---|---|
| Phone | +57 3057532484 |
| mestebanc@unbosque.edu.co |
Scientific
Calle 134 #17-71
Bogotá D.C
110121
Colombia
| ORCID ID |
0000-0002-2127-7696 |
|---|---|
| Phone | +57 3106182238 |
| eugenio.ferro@icsn.co |
Public
Calle 134 #17-71
Bogotá D.C
110121
Colombia
| ORCID ID |
0009-0000-3502-0253 |
|---|---|
| Phone | +57 3238129463 |
| amagomez@unbosque.edu.co |
Study information
| Study design | Single-center interventional randomized and controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life, Treatment, Efficacy |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet |
| Scientific title | High vs low-frequency music therapy in psychiatric inpatients: A randomized, controlled clinical trial |
| Study acronym | HILOM-PSY |
| Study hypothesis | Patients receiving high-intensity music therapy (5 sessions per week) show a significantly greater reduction in anxiety, depression and stress levels, greater overall life satisfaction and a greater perceived impact of music therapy sessions, compared to patients receiving low-intensity music therapy (1 session per week). |
| Ethics approval(s) |
Approved 26/07/2024, C.E.I Campo Abierto LTDA (Carrera 53 #104B-35 Office 706, Bogotá D.C, 111111, Colombia; +57 3106974943; eticaeninvestigacion@hotmail.com), ref: Acta 209 |
| Condition | Anxiety, depression, stress, general life satisfaction and perceived impact of music therapy in psychiatric inpatients. |
| Intervention | This is a randomized controlled clinical trial. Participants were randomly assigned with a 1:1 ratio to either the high-frequency music therapy intervention group or the low-frequency control group. Randomization was performed by random number generation. The high-frequency intervention group received five sessions of music therapy in one week of inpatient treatment at a rate of one session per day for five consecutive days. The low-frequency control group received one music therapy session in one week of inpatient treatment. |
| Intervention type | Behavioural |
| Primary outcome measure | Symptoms of depression, anxiety and stress measured using the liked scale: Depression Anxiety Stress Scale of 21 items (DASS-21) at baseline and follow up |
| Secondary outcome measures | 1. Overall life satisfaction measured using Single Item Life Satisfaction Measurement at baseline and follow up 2. Impact of music therapy sessions on adult patients measured using [CISMA-scale] at baseline and follow up |
| Overall study start date | 26/07/2024 |
| Overall study end date | 11/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 74 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 74 |
| Participant inclusion criteria | 1. Individuals over 18 years of age 2. More than 48 hours of psychiatric hospitalization at the time of recruitment 3. Pharmacological treatment with medication adjustments in the last two weeks |
| Participant exclusion criteria | 1. Previous participation in music therapy programs 2. Main diagnosis of hospitalization abstinence syndrome or substance dependence 3. More than six days of hospitalization at the time of selection |
| Recruitment start date | 01/08/2024 |
| Recruitment end date | 01/09/2024 |
Locations
Countries of recruitment
- Colombia
Study participating centre
Bogotá D.C
110121
Colombia
Sponsor information
Hospital/treatment centre
Calle 134 #17-71
Bogotá D.C
110121
Colombia
| Phone | +57 6012596000 |
|---|---|
| eugenio.ferro@icsn.co | |
| Website | https://clinicamontserrat.com.co/ |
University/education
Av. Cra. 9 No. 131 A - 02
Bogota D.C
110121
Colombia
| Phone | +57 6016489000 |
|---|---|
| investigacion@icsn.co | |
| Website | https://www.unbosque.edu.co |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 15/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated and analysed during the current study will be stored in a publicly available repository OpenScienceFramework https://osf.io/384fb/ |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/11/2024 | No | No |
Additional files
Editorial Notes
16/10/2024: Trial's existence confirmed by C.E.I Campo Abierto LTDA.
