Trial Outcomes & Findings for Song-making In a Group (SING) R61 (NCT NCT05537428)

Last Updated: 2025-06-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

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

Results posted on

2025-06-15

Participant Flow

Participant milestones

Participant milestones
Measure	Musical Intervention Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions 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.
Overall Study STARTED	39
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

one participant did not report an age

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Musical Intervention n=35 Participants Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions 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.
Age, Categorical <=18 years	0 Participants n=34 Participants • one participant did not report an age
Age, Categorical Between 18 and 65 years	33 Participants n=34 Participants • one participant did not report an age
Age, Categorical >=65 years	1 Participants n=34 Participants • one participant did not report an age
Sex: Female, Male Female	15 Participants n=35 Participants
Sex: Female, Male Male	20 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=35 Participants
Race (NIH/OMB) Asian	1 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	15 Participants n=35 Participants
Race (NIH/OMB) White	15 Participants n=35 Participants
Race (NIH/OMB) More than one race	2 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=35 Participants
Region of Enrollment United States	35 participants n=35 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Musical Intervention n=35 Participants Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions 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.
Change in Language Use Assessed Using Word Count Pre-Intervention	9.93 word count Standard Deviation 1.91
Change in Language Use Assessed Using Word Count Post-Intervention	8.57 word count Standard Deviation 2.00

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Musical Intervention n=35 Participants Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions 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.
Change in Social Belief Updating Pre win switch rate	0.135 win-switches Standard Deviation 0.141
Change in Social Belief Updating Post win switch rate	0.127 win-switches Standard Deviation 0.190

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Musical Intervention n=39 Participants Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions 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.
Change in Social Belief Updating- Volatility Pre-Intervention	0.239 Mu3 Standard Deviation 0.523
Change in Social Belief Updating- Volatility Post-Intervention	-0.00860 Mu3 Standard Deviation 0.819

PRIMARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Musical Intervention n=35 Participants Participants will work together in a group with other voice hearers, making music with a trained facilitator for 4 weekly sessions 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.
Change in Conditioned Hallucinations Pre-Intervention	0.181652 mean number tone on no tone trials Standard Deviation 0.148496
Change in Conditioned Hallucinations Post-Intervention	0.166301 mean number tone on no tone trials Standard Deviation 0.161581

Adverse Events

Musical Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip Corlett

Yale University

Phone: 2039747866

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place