- Design
- Randomised controlled non-inferiority trial
- Population
- 172 adults with mild-to-moderate stress-related mental ill health in primary care
- Primary outcome
- Perceived Stress Scale-10 over 12 weeks
- Effect
- d = 0.22 favouring guided CBT; upper CI 0.52 exceeded the 0.3 margin
A Swedish randomised non-inferiority trial allocated 172 adults with mild-to-moderate stress-related mental ill health in primary care to nurse-led collaborative care or to CBT delivered as psychologist-guided self-help, for 12 weeks.
Both groups improved substantially on stress, exhaustion, sleep, depression, anxiety and quality of life. The difference in perceived stress favoured guided CBT (effect size 0.22), and the upper limit of its confidence interval (0.52) exceeded the pre-set non-inferiority margin of 0.3, so nurse-led care was not shown to be non-inferior. Guided CBT also reduced exhaustion slightly more.
In a practice without a psychologist, which describes most primary care in India, nurse-led collaborative care is a reasonable, safe option that produced real improvement. Where guided CBT is available, it remains the slightly better choice.
- Where guided CBT is available, prefer it for stress-related mental ill health.
- Where it is not, nurse-led collaborative care is a reasonable alternative that produced substantial improvement.
- Screen for depression and exhaustion at the first visit, as both improved with structured care.
- Review at about 12 weeks and step up if symptoms persist.
Why it matters
Most patients with stress first see a family physician, and few practices have a psychologist on hand.
Don't overread it
Both groups improved, but there was no untreated control group, so part of the improvement may be natural recovery.
The statistics, in plain English
A non-inferiority trial asks whether a new option is no worse than the standard by more than an agreed margin. Here the margin was 0.3; the worst plausible difference was 0.52, so the trial could not rule out that nurse-led care is meaningfully less effective, although the best estimate (0.22) is small.
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