Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT05929352

Song-making In a Group (SING)

Led by Yale University · Updated on 2025-07-29

200

Participants Needed

1

Research Sites

189 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

N

National Institute of Mental Health (NIMH)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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. This protocol focuses on the R33 phase, to optimize its administration (Is active participation more effective than passive listening? Does creation of new music help more than performing others' creations?). By tracking the interrelation between symptom mechanisms and MI, the investigators can use those metrics to prospectively assign patients to particular MI. The R33 phase will examine the impact of SING on computational behavioral metrics of (Aim 1) Conditioned Hallucinations, (Aim 2) Social Reinforcement Learning, (Aim 3) Language Use, in 200 participants with voice hearing in the context of a psychotic illness (n=50per per group). Following a screening visit to determine eligibility, these computerized tasks will be administered behaviorally, and an interview will elicit speech, prior to and following the full SING intervention (in 10 groups of 5 participants, each facilitated by a trained musical interventionist, during the first two years of the project). Participants will complete these tasks prior to and following randomization to four different conditions (facilitated by a SING team member) that will deconstruct the possible active ingredients of SING along two dimensions: Activity and Ownership: (a) SING (n=50, Activity + and Ownership +), participants produce and perform their own song; (b) Karaoke (n=50, Activity + and Ownership -), participants perform karaoke, singing along to others music; (c) Pop Music (n=50, Activity - and Ownership -), participants will listen to popular music chosen by the music interventionists; and (d) Curated Playlists (n=50, Activity -, Ownership +), participants will curate playlists of popular music and listen to them together. This deconstruction will provide insights into the predictive processing framework, as applied to hallucinations and music, specifically, whether changes at higher, a-modal, hierarchical levels, particularly sense of self and active inference, influence precision weighted perceptual and social inferences more so than inactive experiences or experiences that do not engage sense of self. This R33 portion of the study was originally included in NCT05537428, which now has results posted for the R61 phase of the study.

CONDITIONS

Official Title

Song-making In a Group (SING)

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voice hearing patients meeting Diagnostic and Statistical Manual-V criteria for psychotic disorder
  • Hearing voices at least once a day
  • PANSS P3 (Hallucinations item) score greater than 3
  • Ability to give informed consent and cooperate with study procedures
  • Probability of completing the study as assessed by interaction with study team
Not Eligible

You will not qualify if you...

  • Substance abuse or dependence within past six months according to DSM-IV
  • Clinically significant medical conditions or head injury with neurological symptoms
  • Mental retardation with IQ less than 70
  • Non-English speaking
  • Less than two weeks of stable psychotropic medication doses
  • Co-morbid mood or anxiety disorder
  • Clinically or behaviorally unstable and unable to cooperate with study procedures
  • Unstable medical condition based on history, physical exam, or lab tests

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Department of Psychiatry, Yale School of Medicine

New Haven, Connecticut, United States, 06519

Actively Recruiting

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Research Team

P

Philip R Corlett, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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