N/A
Completed N=39
Song-making In a Group (SING) R61
Source: ClinicalTrials.gov NCT05537428 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcomePrimary: Change in Language Use Assessed Using Word Count — 9.93; 8.57 word count
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Language Use Assessed Using Word Count |
9.93; 8.57 | — |
| PRIMARY Change in Social Belief Updating |
0.135; 0.127 | — |
| PRIMARY Change in Social Belief Updating- Volatility |
0.239; -0.00860 | — |
| PRIMARY Change in Conditioned Hallucinations |
0.181652; 0.166301 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05537428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.