Mania Clinical Trial
Official title:
A Pilot Randomised Controlled Trial of Cognitive Behaviour Therapy for Early Bipolar Disorder
There is a need to develop a better understanding of the early phase of bipolar disorder, and to develop and evaluate effective psychosocial interventions that assist people in this phase. The purpose of this study is to determine whether or not it is feasible to conduct a larger study of the effectiveness of cognitive interpersonal therapy (a psychological therapy) with individuals who have experienced their first or second treated episode of mania or hypomania (symptoms common in early development of bipolar disorders).
The 'PICO' framework (Oxman, Sackett, and Guyatt, 1993; Richardson, Wilson, Nishikawa, and
Hayward; 1995) was used to specify the parameters of the study aims and objectives:
1. Population: could appropriate individuals be identified and recruited to a trial of CIT
for early bipolar disorder?
2. Intervention: would CIT be an acceptable intervention for individuals following a first
or second treated episode of mania and or hypomania? Could we identify any
modifications required to the CIT protocol used with this group?
3. Control group: could an appropriate group of participants be recruited to facilitate a
comparison with the CIT intervention? Could we explicitly establish the usual care
package and its local implementation?
4. Outcomes: which outcomes are appropriate for measuring relevant dimensions of a
treatment effect?
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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