NCT05929352 · Yale University
Song-making In a Group (SING)
(SING_R33)
What this study 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?).
View original scientific description
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.
Interventions
BEHAVIORAL
Musical Intervention
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.
Primary outcome measures
Change in Language Use
Time frame: baseline and Within one week of study completion (final MI session of 4)
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
Change in Social Belief Updating
Time frame: baseline and Within one week of study completion (final MI session of 4)
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.
Change in Conditioned Hallucinations
Time frame: baseline and Within one week of study completion (final MI session of 4)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New Haven, Connecticut
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 29, 2025 · Source of record for eligibility and locations