This pragmatic SMART study randomised 316 young people with severe anxiety to initial fluoxetine or CBT, then re-randomised week-12 non-remitters. The population is the notable part: high sociodemographic disadvantage and co-occurring diagnoses, which is who fills real clinics and who is usually excluded from efficacy trials.
Youth-reported SCARED scores fell 31.7% over 24 weeks. Initial treatment made no significant difference, with CBT holding a non-significant 1.45-point advantage (interval -2.25 to 5.16). Among non-remitters at week 12, adding the second modality did not beat continuing monotherapy: a difference of -2.74 with an interval from -6.53 to 1.05.
One sequence — CBT first, then combination — separated from the others on a subset of measures, which given the number of comparisons is not something to build practice on.
The implication is liberating rather than deflating. When several treatments produce the same outcome, the tie-breakers become the ones that actually determine whether treatment happens: what the family will accept, what they can attend, what they can afford, and what the young person will engage with. Those are not soft considerations here — they are the difference between treatment delivered and treatment declined.
- Severe anxiety with disadvantage and comorbidity — an unusually representative sample
- No significant difference by initial treatment or by post-week-12 sequence
- Combination did not rescue week-12 non-remitters beyond continuing monotherapy
- The one sequence that separated did so on a subset of measures only
- Access, acceptability and cost become the legitimate deciding factors
The statistics, in plain English
The 24-week difference of 1.45 with an interval from -2.25 to 5.16 includes zero and is small either way — this is a well-powered null rather than an inconclusive one. That distinction matters: the trial can say these options are similar, not merely that it failed to tell them apart. A SMART design tests sequences rather than single choices, which is why it can also answer what to do at week 12.
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