2. Suggested design for a trial of dance therapy.
Methods | Allocation: centralised sequence generation with table of random numbers or computer‐generated code, stratified by severity of illness, sequence concealed till interventions assigned. Blinding: those recruiting and assigning participants, those assessing outcomes, all blind to allocated group, blinding tested. Duration: minimum of 52 weeks. |
Participants | Diagnosis: schizophrenia, if operational criteria used these should be in the context of routine care. N = 300*. Age: adults. Sex: men and women. Setting: anywhere dance therapy is available for this group. |
Interventions | 1. Dance therapy: the nature and frequency of this approach should be clearly described. N = 150. 2. Routine therapy. N = 150. This also should be clearly described. |
Outcomes | Quality of life: healthy days,** SF‐36***. Service outcomes: days in hospital, time attending psychiatric outpatient clinic. Satisfaction with care: patients/carers. Global state: CGI.*** Mental state: CGI. Social functioning: to include occupational status. Adverse effects: including mortality. Economic data. |
Notes | * size of study to detect a 10% difference in improvement with 80% certainty. ** Primary outcome. *** If scales are used to measure outcome then there should be binary cut off points, defined before study starts, of clinically important improvement. |
CGI: Clinical Global Impression