BMJ mental health · 2026
Early interventions for primary care patients with stress-related mental ill health: a randomised controlled non-inferiority trial of a nurse-led collaborative care intervention versus cognitive behavioural therapy.
СтатьяРандомизированное исследованиеEquivalence TrialНазвание и аннотация: Перевод пока не подготовлен
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Kontio Evelina, Sennerstam Victoria, Svärdman Frank, Samuelsson Conrad, Hettman Janina, Broman Nathalie, Franke Föyen Ludwig, Ejeby Kersti, Lindsäter Elin, Hedman-Lagerlöf Erik
Аннотация
BACKGROUND: Stress-related mental ill health is highly prevalent, and most individuals first seek help in primary care where access to psychological support is often limited.
OBJECTIVE: To test whether nurse-led collaborative care (CC) is non-inferior to cognitive behavioural therapy delivered as psychologist-guided self-help (GSH-CBT) in reducing stress for adult primary care patients with stress-related mental ill health.
METHODS: A randomised controlled non-inferiority trial where 172 adult primary care patients with mild to moderate stress-related mental ill health were allocated to nurse-led CC or GSH-CBT (1:1). The primary outcome was the Perceived Stress Scale-10 administered every 3 weeks during the 12-week treatment phase. The a priori non-inferiority margin was 0.3 d, requiring the one-sided 95% CI of the effect size to fall within this bound. Secondary outcomes were symptoms of exhaustion, sleep problems, depressive symptoms, general anxiety and quality of life.
FINDINGS: In both conditions, participants showed large, significant within-group improvements on the primary outcome and all secondary outcomes. The primary outcome showed a small between-group difference (d=0.22), favouring GSH-CBT, with the CI upper bound (0.52) exceeding the non-inferiority margin. For secondary outcomes, GSH-CBT led to a greater reduction in exhaustion (d=0.28; 95% CI 0.64 to 0.002). No other between-group differences were observed.
CONCLUSIONS: Nurse-led CC was not non-inferior to GSH-CBT. Effect differences were small, but improvements were slightly larger in GSH-CBT.
CLINICAL IMPLICATIONS: Given that nurse-led CC is safe, easy to administer, and that significant within-group improvements were observed across all measures, this intervention could be a viable option in primary care settings where psychologist-delivered treatment is limited.
OBJECTIVE: To test whether nurse-led collaborative care (CC) is non-inferior to cognitive behavioural therapy delivered as psychologist-guided self-help (GSH-CBT) in reducing stress for adult primary care patients with stress-related mental ill health.
METHODS: A randomised controlled non-inferiority trial where 172 adult primary care patients with mild to moderate stress-related mental ill health were allocated to nurse-led CC or GSH-CBT (1:1). The primary outcome was the Perceived Stress Scale-10 administered every 3 weeks during the 12-week treatment phase. The a priori non-inferiority margin was 0.3 d, requiring the one-sided 95% CI of the effect size to fall within this bound. Secondary outcomes were symptoms of exhaustion, sleep problems, depressive symptoms, general anxiety and quality of life.
FINDINGS: In both conditions, participants showed large, significant within-group improvements on the primary outcome and all secondary outcomes. The primary outcome showed a small between-group difference (d=0.22), favouring GSH-CBT, with the CI upper bound (0.52) exceeding the non-inferiority margin. For secondary outcomes, GSH-CBT led to a greater reduction in exhaustion (d=0.28; 95% CI 0.64 to 0.002). No other between-group differences were observed.
CONCLUSIONS: Nurse-led CC was not non-inferior to GSH-CBT. Effect differences were small, but improvements were slightly larger in GSH-CBT.
CLINICAL IMPLICATIONS: Given that nurse-led CC is safe, easy to administer, and that significant within-group improvements were observed across all measures, this intervention could be a viable option in primary care settings where psychologist-delivered treatment is limited.