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Table 7 Adverse events and classification by treatment arm

From: Group music therapy with songwriting for adult patients with long-term depression (SYNCHRONY study): a feasibility and acceptability study of the intervention and parallel randomised controlled trial design with wait-list control and nested process evaluation

Event

Classification

During treatment

During follow-up assessments

Treatment

N = 20

Control

N = 10

Expected?

Related?

Verbal threat

Adverse event

1

0

1

0

Expected

Probably unrelated

Increased suicide risk

Adverse event

1a

2

2

1

Expected

Unrelated

Disclosure of risk to self/others

Adverse event

0

1

1

0

Expected

Probably unrelated

Hospitalisation

Serious adverse event

0

1

1b

0

Expected

Unrelated

Faint during research assessment

Adverse event

0

1

0

1

Unexpected

Unrelated

Homelessness

Safeguarding alert

2

0

2

0

Unexpected

Unrelated

Total number of events

 

4

5

7

2

  
  1. aRisk identified during research assessment after the therapy group
  2. bParticipant did not attend any group sessions