Music Therapy for Schizophrenia

(SING_R33 Trial)

Overseen By Philip R Corlett, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Substance abuse, Head injury, IQ<70, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 4 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how music therapy can assist people who hear voices, a common symptom of schizophrenia. Researchers aim to determine whether creating and performing music or simply listening to it affects symptoms differently. Participants will join one of four groups to test various music activities, such as singing karaoke or making playlists. The trial seeks individuals who hear voices daily as part of a psychotic disorder diagnosis. The goal is to identify which musical activities might best improve symptoms related to hearing voices. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance therapeutic options for managing schizophrenia symptoms.

Do I need to stop my current medications for the trial?

No, you don't need to stop your current medications. You must have at least 2 weeks of stable doses of psychotropic medications before participating.

Will I have to stop taking my current medications?

The trial requires that participants have at least 2 weeks of stable doses of their current psychotropic medications, so you will not need to stop taking them. Your medication type and dose will be recorded and considered in the study analysis.

What prior data suggests that this protocol is safe for participants with schizophrenia?

Research shows that music therapy is generally safe for people with schizophrenia. Studies have found that it can improve mental health and lessen the severity of psychotic symptoms, indicating positive patient responses to these treatments.

In one study with 67 patients, music therapy reduced psychological symptoms without causing major side effects. Another study found that group music activities helped lower the severity of symptoms in people with acute schizophrenia. These findings suggest that music therapy is well-tolerated and can complement traditional treatments.

Overall, evidence indicates that music therapy is a safe option for those with schizophrenia, with no significant negative effects reported in the research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for schizophrenia, which often include antipsychotic medications, music therapy offers a non-medical approach that engages patients in a creative process. Researchers are excited about this innovative treatment because it provides a unique way for individuals to express themselves and connect with others through music, which can be particularly beneficial for those who experience auditory hallucinations. This approach not only aims to alleviate symptoms but also enhances social interaction and emotional well-being, potentially offering a holistic complement to traditional care.

What evidence suggests that this trial's musical interventions could be effective for schizophrenia?

Research has shown that music therapy can help people with schizophrenia. A review of 19 studies found that music therapy significantly improved negative and cognitive symptoms of psychosis, with a strong positive impact. Other studies suggest that music therapy can enhance mental health, daily functioning, and quality of life for those with schizophrenia. In this trial, participants will engage in a Musical Intervention, working together in a group with other voice hearers to make music with a trained facilitator for four weekly sessions. Group music activities have lessened the severity of psychotic symptoms. Additionally, music therapy can help individuals who may not respond well to traditional talk therapy. Overall, strong evidence supports the benefits of music therapy for people experiencing schizophrenia. ^{2 3 4 6 7}

Who Is on the Research Team?

Philip R Corlett, PhD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals who hear voices daily and have been diagnosed with a psychotic disorder as per the Diagnostic and Statistical Manual-V. They must exhibit moderate hallucinations, be able to give informed consent, interact well with the study team, and likely complete the study.

Inclusion Criteria

Voice hearing patients meeting diagnostic criteria for Diagnostic and Statistical Manual-V psychotic disorder

I hear voices daily.

PANSS P3 (Hallucinations item) greater than 3

Exclusion Criteria

My mental health medication dose has been stable for at least 2 weeks.

Clinically/behaviorally unstable and unable to cooperate with SING procedures

Diagnostic and Statistical Manual-IV substance abuse or dependence (past six months)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants engage in the SING intervention, involving music-making activities in groups with a trained facilitator

4 weeks

4 weekly sessions

Follow-up

Participants are monitored for changes in language use, social belief updating, and conditioned hallucinations

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Musical Intervention

Trial Overview

The SING trial tests how different forms of musical intervention affect people with schizophrenia. Participants are randomly assigned to create music, perform karaoke, listen to pop music or curate playlists. The impact on hallucinations, social learning, and language use is measured.

How Is the Trial Designed?

Group I: Musical Intervention Experimental Treatment 1 Intervention

Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions

Musical Intervention is already approved in United States for the following indications:

Approved in United States as Musical Intervention for:

• Psychotic illnesses
• Conditioned Hallucinations
• Social Reinforcement Learning
• Language Use

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study involving 67 patients with schizophrenia, group music activity as an adjunctive therapy significantly reduced psychotic symptoms, as measured by the Brief Psychiatric Rating Scale (BPRS).

The intervention consisted of 50-minute group music sessions held five times a week for 2 weeks, demonstrating that incorporating music therapy can enhance standard care for patients in acute psychiatric settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of group music activity as an adjunctive therapy on psychotic symptoms in patients with acute schizophrenia. Peng, SM., Koo, M., Kuo, JC.[2010]

Assisted music therapy combined with drug therapy significantly improved symptoms in chronic schizophrenia patients compared to drug therapy alone, as shown by lower scores on the SANS and BPRS scales in the experimental group.

The study analyzed 11 articles with a total of 603 patients, indicating that while short-term benefits of music therapy are evident, further research is needed to assess its long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Meta-analysis of assisted music therapy for chronic schizophrenia]. You, ZY., Wang, JZ.[2006]

Music therapy is well-accepted by schizophrenic patients, showing no negative effects even when introduced during the post-acute phase of treatment, based on a study of 30 patients.

The therapy provides positive benefits such as relaxation, reduced anxiety, and improved emotional expression, although the duration of these effects is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Music therapy evaluated by schizophrenic patients]. Reker, T.[2006]

In a study of 60 participants experiencing acute psychotic episodes, music therapy as an adjunct to standard pharmacological treatment showed a statistically significant improvement in Brief Psychiatric Rating Scale (BPRS) scores for the treatment group compared to the control group.

Although the treatment group experienced a 9.3% reduction in hospital stay length, this finding was not statistically significant, suggesting that while music therapy may benefit some patients, its overall impact on hospitalization and other psychological assessments remains inconclusive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A controlled trial investigating the effect of music therapy during an acute psychotic episode. Morgan, K., Bartrop, R., Telfer, J., et al.[2011]

Music therapy, particularly when delivered in a combined format (active and receptive), significantly improves various outcomes for individuals with schizophrenia, including psychotic symptoms, depression, anxiety, and overall quality of life, based on a review of 17 studies.

The dosage of music therapy is crucial, with higher exposure times (ranging from 20 to 9,720 minutes) leading to better results, suggesting that more extended therapy sessions are more effective than shorter ones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Dosage and Type of Music Therapy in Symptom Management and Rehabilitation for Individuals with Schizophrenia. Chung, J., Woods-Giscombe, C.[2019]

In a study involving 80 patients with schizophrenia, those who participated in group music therapy showed significant improvements in psychiatric symptoms and depression compared to those who received usual care.

The music therapy consisted of 10 sessions, each lasting 60 minutes, and was found to be an effective and cost-efficient intervention for enhancing mental health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of group music intervention on psychiatric symptoms and depression in patient with schizophrenia. Lu, SF., Lo, CH., Sung, HC., et al.[2013]

In a study of 76 in-patients with the residual subtype of schizophrenia, music therapy combined with standard medication significantly reduced negative symptoms and improved social interaction and interest in external events.

Music therapy is a safe and cost-effective intervention with no side effects, suggesting it could be beneficial for broader use in treating schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitative effect of music therapy for residual schizophrenia. A one-month randomised controlled trial in Shanghai. Tang, W., Yao, X., Zheng, Z.[2008]

Adjunct music therapy significantly improved overall symptoms, negative symptoms, depression symptoms, and quality of life in patients with schizophrenia, based on a meta-analysis of 18 studies involving 1,212 participants.

Despite these positive findings, the quality of evidence is considered low, indicating a need for more well-designed studies with larger sample sizes to further confirm the efficacy of music therapy in treating schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of adjunct music therapy for patients with schizophrenia: A meta-analysis. Jia, R., Liang, D., Yu, J., et al.[2021]

Different types of music therapy, including listening, singing, dancing, and playing instruments, can be effectively combined to create a graduated group-centered approach for treating schizophrenia.

The study suggests that music therapy can significantly influence anxiety and activity levels in individuals with schizophrenia, promoting more appropriate communication and behavior within the group setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Possibilities for inclusion of group music therapeutic methods in the treatment of psychotic patients]. Schmuttermayer, R.[2006]

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Music Therapy for Schizophrenia (SING_R33 Trial)

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A consistent finding among these reports has been music therapy's effectiveness with clients considered poor candidates for traditional verbal group therapy.

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Treatment effects of adjunct group music therapy in ...

A comprehensive systematic analysis of all RCTs found that music therapy for schizophrenia and schizophrenia-like diseases improves overall ...

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Effect of Group Music Activity as an Adjunctive Therapy ...

In their study of 67 patients with schizophrenia, Peng, Koo, and Kuo (2010) found that music therapy decreased the psychological symptoms of ...