Song-making In a Group (SING)

NCT05929352 | Recruiting

• 2 other identifiers: 2000026376: SING_a4R33MH123028-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Schizophrenia

Keywords

Hallucinations

Outcome Measures

Primary Outcomes (3)

• Change in Language Use

  Speech patterns of participants will be analyzed pre and post intervention using the Linguistic Inquiry and Word Counting Program on interviews conducted prior to and post musical intervention

  baseline and Within one week of study completion (final MI session of 4)

• Change in Social Belief Updating

  Social belief updating under uncertainty will be analyzed using a probabilistic reversal learning task. Participants will be asked to choose between stimuli on a computer screen that will increase or decrease their points score. Participants should choose the best deck as much as possible, and should understand that the best deck can change from time to time. Points achieved as well as the patterns of errors committed will be analyzed.

  baseline and Within one week of study completion (final MI session of 4)

• Change in Conditioned Hallucinations

  Participants susceptibility to conditioned hallucinations during a perceptual inference task that presents auditory and visual stimuli through a computer program will be analyzed. Participant reports of hearing tones conditional on visual stimuli will be the key outcome.

  baseline and Within one week of study completion (final MI session of 4)

Study Arms (1)

Musical Intervention

EXPERIMENTAL

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

Behavioral: Musical Intervention

Interventions

Musical Intervention BEHAVIORAL

A trained musician-facilitator will convene a series of four weekly two-hour sessions to which groups of five participants will be invited. The facilitator provides keyboard, professional microphone, recording interface, headphones, guitar, computer and a Digital Audio Workstation (DAW) for recording.

Musical Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Department of Psychiatry, Yale School of Medicine

New Haven, Connecticut, 06519, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Hallucinations

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Philip R Corlett, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philip R Corlett, PhD

CONTACT

2039747866; philip.corlett@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: October 14, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: They will be shared with researchers one year after study completion
• Access Criteria: People wishing to access the data need to do so via the National Institute of Health National Database site

Locations

US (1)