Song-making In a Group (SING) R61

NCT05537428 | Completed Results

• 2 other identifiers: 2000026376: SING1R61MH123028-01
• Study Type: interventional
• Target: 39
• 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. The R61 phase (that this registration covers) will investigate the impact of group musical intervention on predictive processing metrics of hallucinations and social dysfunction.

Conditions

Schizophrenia

Keywords

Hallucinations

Outcome Measures

Primary Outcomes (4)

• Change in Language Use Assessed Using Word Count

  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. The use of personal pronouns was quantified using James Pennebakers Linguistic Inquiry and word counting software (LIWC). The LIWC suggests that the frequent use of I is related to distress. The investigators compared use of I pre and post music visits. A decrease in usage post intervention indicates a positive outcome.

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

• 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. Here win-switches are assessed. 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), an average of 5 weeks

• Change in Social Belief Updating- Volatility

  Social belief updating under uncertainty will be analyzed using a model derived parameter on volatility. 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. A model derived parameter on volatility, Mu3, is based on participants behavior and their belief about how volatile the task might be. It has arbitrary units.

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

• 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), an average of 5 weeks

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

Location

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

Results Point of Contact

• Title: Philip Corlett
• Organization: Yale University

philip.corlett@yale.edu

2039747866

Study Officials

• Philip R Corlett, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: October 31, 2020
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 15, 2025
• Results First Posted: September 1, 2023

Record last verified: 2025-06

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)