Song-making In a Group (SING)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT05929352
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Oct 14, 2022
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
May 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Change in Language Use [ Time Frame: baseline and Within one week of study completion (final MI session of 4) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Department of Psychiatry, Yale School of MedicineNew HavenConnecticut06519
Philip Corlett, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New Haven, CT

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Department of Psychiatry, Yale School of Medicine· New Haven, CT

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