To evaluate the effect of the LEARN-to-COPE intervention on sick leave, symptoms, and coping.

Cluster-randomized controlled trial including 40 primary care centers (PCCs) in Region Västra Götaland, Sweden. Randomization at the PCC level. Effect of the intervention was compared to Care-as-Usual (CAU). Follow-up was conducted using registry sick leave data, validated questionnaires, and patient-reported data.

Primary healthcare patients with recurrent or long-term sick leave or health-related unemployment from included PCCs (n = 243).

Patient education was conducted via interactive study groups, which convened for half a day every week over eight consecutive weeks. Implementation was centralized in close collaboration with educational associations. The purpose of the intervention was to strengthen participants' sense of coherence and health literacy, with the aim of enhancing their work ability and health.

The primary outcome measure was change in scheduled activity, derived from data on sick leave (obtained from the Swedish Social Insurance Agency) and participation in work-oriented rehabilitation (self-reported occupational status). Secondary outcomes (symptoms and coping) were measured with validated questionnaires at baseline and follow-ups after 3, 6, and 12 months.

Included participants suffered from anxiety, depression, exhaustion, and pain and had poor health-related quality of life. After 12 months, there was no significant change in scheduled activity, sense of coherence, symptoms, or health-related quality of life, but a statistically significant positive change in health literacy and self-efficacy was found in the intervention group.

Considering participants' pronounced burden of symptoms, the focus should be on improving the sick leave process as a whole, rather than seeking quick remedies for patients' complex health issues. Centralized implementation of the intervention was a promising concept that deserves further evaluation.

Clinicaltrials.gov NCT04254367.