NCT05929352Befejeződött
Song-making In a Group (SING)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 20.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 135 (tényleges)
- Első benyújtás
- 2023. jún. 23.
- Kezdés
- 2022. okt. 14.
- Elsődleges befejezés
- 2025. nov. 25.
- Fő szponzor
- Yale University
- Betegségek
- Skizofrénia
- NCT-szám
- NCT05929352
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 135
- 2022. okt. 14. és az elsődleges befejezés (2025. nov. 25.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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)
Más betegség
- clinically significant medical conditions, head injury with neurological symptoms or unconsciousness
Laborértékek
- Unstable medical condition based on medical history, physical examination and routine laboratory work-up
Egyéb
- Diagnostic and Statistical Manual-IV substance abuse or dependence (past six months)
- mental retardation (IQ\<70)
- Non-English speaking
- Co-morbid mood or anxiety diagnosis
- clinically/behaviorally unstable and unable to cooperate with SING procedures
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Department of Psychiatry, Yale School of Medicine Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | New Haven | Egyesült Államok | Ismeretlen állapot |
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