Music Therapy Towards Schizophrenia, Negative Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Aim of this National study is to examine whether music therapy can reduce negative symptoms and raise Quality of Life for patients suffering from Schizophrenia. It is an Randomized Controlled Trial (RCT), double-blinded study with two arms. 120 Participants are anticipated. The two Arms consist of 25 weekly hours of Music Therapy by educated Music Therapists and time compensated Music Listening by unknown Care Staff Members.

The Study is a close Cooperation between Aalborg University (The Music Therapy Research Clinic) and Aalborg University Hospital, Psychiatry.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Music Therapy and Bio-psychological Effect Among Chronic Psychiatric Inpatients of a Community Teaching Hospital

NCT04254965

Chronic Psychosis

UNKNOWN NA

Effects of Music Beat on Motor Function in Individuals At Risk for Psychotic Onset and Schizophrenia Patients

NCT04929795

Schizophrenia Psychosis Parkinsonism +1 more

COMPLETED NA

Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation

NCT00137189

Mental Disorders Mood Disorders Personality Disorders +1 more

COMPLETED NA

Music Intervention in the Treatment of Sleep Disorders for Depressed Patients

NCT02376686

Insomnia Depression

COMPLETED NA

Music Therapy's Impact on University Students' Social and Mental Health

NCT07024979

Depressive Symptoms Anxiety Stress

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Schizophrenia includes 1 % of the Population in Denmark (DK) and often ends up to be chronically. Negative Symptoms are difficult to reduce by Medication and Psychosocial Treatment Possibilities are searched for. Three Cochrane Reviews (2005, 2011, 2017) have been conducted concerning Music Therapy and Schizophrenia with Positive Results. This RCT, double-blinded Study aims at verifying, if these Results can be Recognized in the Danish Health System. It also aims at being similar to Biomedical Study Designs as much as possible to strengthen the Evidence of the Study. A Power Calculation showed, that a minimum of 44,5 Participants in each Arm should be available, but as drop out can be anticipated with this Population, 60 Participants in each Arm were recommended. The screening Procedure is Comprehensive as it aims at securing, that the negative Symptoms are part of the Illness Schizophrenia and not side Effects from Medication or simultaneous Depression (See the Inclusion- and Exclusion criteria).

The Measurement Tools are as follows:

At Baseline, after 15 Sessions and at Termination:

* The Positive and Negative Syndrome Scale (PANSS),
* Brief Negative Symptom Scale (BNSS),
* Quality of Life (WHOQOL-Bref),
* Calgary Depression Scale for Schizophrenia (CDSS),
* Board of Clinical Examinations (Danish Questionnaire) (UKU)
* Global Assessment of Functioning Scale (GAF) 4 Weeks after Termination Follow Up Interview. In the Arm of Music Therapy Audio Recording of Music Interventions are done in Session 1,15 and 25.
* Helping Alliance Questionnaire, patient version, (Haq-II) This Haq-II is filled out after 5 sessions and after 15 Sessions and at Termination together with a Research Assistant in both Arms.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Music Therapy

25 Weekly Hours of Music Therapy adapted to the Needs of the Participants. Interventions can be Active (playing Music, singing, improvising, Song-writing) or Receptive (Listening to selected Play-lists, or to the Participants´ favored Music).

A Manual is created and trained with the Music Therapists, which distinguishes between

1. Unique and Essential Principles for Music Therapy with people suffering from Schizophrenia with negative Symptoms,
2. Essential but not Unique Principles,
3. Acceptable but not necessary Principles,
4. Not acceptable and Proscribed Principles. These Principles concern Attitude and Listening Perspectives by the Music Therapist, how to conduct the Musical Interventions and Questions of Frames for the Music Therapy Work.

Group Type EXPERIMENTAL

Music therapy

Intervention Type OTHER

25 Weekly Hours of Music Therapy by an Educated Music Therapist

Music Listening

25 Weekly Hours of Being together with an unknown Care Staff Member listening to Music from selected Play-Lists. Music Therapists at the Music Therapy Research Clinic at Aalborg University Hospital, Psychiatry have developed Play-Lists in a Taxonomy from very Supportive to less Supportive Music including around 100 Hours of Music all together on the Lists.

A Manual is created and trained with the Care Staff Members. Here the Activities are much more limited (only Music Listening to the Play-Lists are allowed). No Therapeutical Conversation is allowed.

Group Type ACTIVE_COMPARATOR

Music Listening

Intervention Type OTHER

25 weekly Hours of Being Together with an unknown Care Staff Member

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Music therapy

25 Weekly Hours of Music Therapy by an Educated Music Therapist

Intervention Type OTHER

Music Listening

25 weekly Hours of Being Together with an unknown Care Staff Member

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 - 65 years
* A Diagnosis of Schizophrenia International Classification of Diseases (ICD-10 (F20))
* The Positive and Negative Syndrome Scale (PANNS), negative subscale has to show ≥ 4 on two of the following parameters:

(N1) subdued affect, (N2) emotional withdrawal, (N3) poor contact and (N4) passive/apathetic social withdrawal.

Exclusion Criteria

* Debut of schizophrenia less than 2 years ago.
* Patients in acute worsening of schizophrenia defined as hospitalization within the last three months.
* PANNS positive subscale (P1-P7) \>28.
* Patients who have their psychotropics changed within the last months.
* Significant drug dependency conflicting participation in the study.
* Presence of secondary symptoms defined as Depression - CDSS score \> 7
* Neurological side effects - UKU score \> 1 in one of the following items: 2.1, 2.2, 2.3, 2.5, 2.6
* Sedative side effects - UKU item 1.3 score \> 1.
* No individual music therapy within the last two months

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No