CompletedNot Applicable

Song-making In a Group (SING) R61

United States39 participantsStarted 2020-10-31

Plain-language summary

The overarching aim of the proposed work is to align a promising treatment lead - Musical Intervention (MI) - with a promising mechanistic account of psychosis - Predictive Processing. The R61 phase (that this registration covers) will investigate the impact of group musical intervention on predictive processing metrics of hallucinations and social dysfunction.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * voice hearing patients meeting diagnostic criteria for Diagnostic and Statistical Manual-V psychotic disorder * hearing voices at least once a day * PANSS P3 (Hallucinations item) greater than 3 * Prior to study participation all patients will be evaluated for i) protocol eligibility; ii) ability to give informed consent; iii) interaction with the study team to determine participant's probability of completing the study; and iv) ability to cooperate with protocol procedures. The flow of all participants will be reviewed at weekly research meetings in consultation with the study team. Exclusion Criteria: * Diagnostic and Statistical Manual-IV substance abuse or dependence (past six months) * clinically significant medical conditions, head injury with neurological symptoms or unconsciousness * mental retardation (IQ\<70) * Non-English speaking * no less than 2 weeks of stable doses of psychotropic medications (to avoid transient effects of medication regiment change; medication type and dose will be carefully recorded and used as a covariate in all analyses) * Co-morbid mood or anxiety diagnosis * clinically/behaviorally unstable and unable to cooperate with SING procedures * Unstable medical condition based on medical history, physical examination and routine laboratory work-up

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Language Use Assessed Using Word Count

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks

Change in Social Belief Updating

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks

Change in Social Belief Updating- Volatility

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks

Change in Conditioned Hallucinations

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks

Trial details

NCT IDNCT05537428

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-07-01

Results submitted2023-05-12

View on ClinicalTrials.gov More Schizophrenia trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Language Use Assessed Using Word Count

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks

Change in Social Belief Updating

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks

Change in Social Belief Updating- Volatility

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks

Change in Conditioned Hallucinations

Timeframe: baseline and Within one week of study completion (final MI session of 4), an average of 5 weeks