NCT06315049

Brief Summary

This study aims to measure the effectiveness of the Music Therapy nursing intervention in reducing anxiety in outpatients diagnosed with severe mental illness (SMI) (bipolar disorder and schizophrenia). The intervention was structured over five weeks (ten 1-hour sessions, twice weekly). Objective measures (blood pressure, heart rate, and respiratory rate) and subjective measures (anxiety response and the subjective perception of relaxation) were taken before and after every session.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 18, 2024

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

January 5, 2024

Last Update Submit

March 13, 2024

Conditions

Severe Mental DisorderSchizophreniaBipolar DisorderAnxiety

Keywords

Music therapy

Outcome Measures

Primary Outcomes (5)

  • IDARE test

    Inventario de la ansiedad rasgo-estado (IDARE) is the Spanish version of the State-Trait Anxiety Inventory (STAI), commonly used to obtain a meaningful measure of state anxiety (SA) and trait anxiety (TA).

    1 year

  • SBP

    Systolic blood pressure

    1 year

  • DBP

    Diastolic blood pressure

    1 year

  • HR

    Heart rate

    1 year

  • RR

    Respiratory rate

    1 year

Study Arms (1)

Music therapy group

EXPERIMENTAL

It is formed from all the participants in the study. They participated in the music therapy sessions.

Other: Music therapy

Interventions

Music therapyOTHER

Music therapy sessions to reduce anxiety

Music therapy group

Eligibility Criteria

Age35 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosed with SMI (schizophrenia, bipolar disorder) according to the Diagnostic and Statistical Manual of Mental Disorders DSM-V-TR
  • currently in outpatient psychiatric treatment in their corresponding mental health unit
  • acceptance to enter the study (informed consent); if legally incapacitated, authorization from the patient's legal guardian
  • ability to understand the questions in anxiety questionnaires
  • between 35 and 50 years of age, to focus the study on a specific population (young adulthood above 35 years and middle adulthood) and to narrow the age range so that they can share common recall of musical memories

You may not qualify if:

  • suffering from a dual pathology (diagnosis of mental illness and, at the same time, substance abuse) and who were also in the dependency phase
  • affected by some type of degenerative disease (dementia, Alzheimer's, etc.)
  • presence of positive psychotic symptoms or behavioral disorganization susceptible to admission in the mental health unit
  • deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Politècnica de València

Valencia, 46022, Spain

Location

Related Publications (1)

  • Ibanez-Del Valle V, Sanchez-Martinez V, Silva J. Nurse-Implemented Music Therapy to Reduce Anxiety in Community-Dwelling Individuals with Severe Mental Illness: A Pilot Study. Nurs Rep. 2024 Mar 22;14(2):695-706. doi: 10.3390/nursrep14020053.

    PMID: 38525699DERIVED

MeSH Terms

Conditions

Mental DisordersSchizophreniaBipolar DisorderAnxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Vanessa Ibáñez, PhD

    Universitat de València

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD.

Study Record Dates

First Submitted

January 5, 2024

First Posted

March 18, 2024

Study Start

June 26, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)