Healthy lifestyle promotion via digital self-help for mental health patients in primary care: a pilot study including an embedded randomized recruitment trial.

Aim: This study piloted a digital self-help intervention facilitating healthy lifestyle for patients with mental health problems in primary care. Background: Patients with mental health problems show more unhealthy lifestyle behaviors than the general population and prior research indicates that healthy lifestyle behaviors can improve mental health. Methods: This pilot study assessed use of a self-help digital intervention for healthy lifestyle promotion and included an embedded randomized recruitment trial, where all patients were randomized to digital self-help plus treatment as usual (TAU) or to TAU only. Patients seeking help for mental health problems were recruited from two primary care clinics in Stockholm, Sweden, and offered participation in a healthy lifestyle promotion study via digital self-help. Outcome measures included use-related assessment of inclusion and follow-up rates at both clinics, participant characteristics, and intervention adherence. Secondary outcomes included depression (the Patient Health Questionnaire-9) and anxiety (the GAD-7) up to 10 weeks, and changes in alcohol and tobacco use, physical activity, and diet. Results: The study included 152 patients. The recruitment rate, initially low, increased after involving the clinicians more and maintaining more frequent contact with the patients. The 10-week missing data rate was 33/152 (22%). Participants were 70% (106/152) women, with a mean age of 42 years (SD = 14); fewer than half (38%, n = 58/152) had one or more high-risk unhealthy behaviors at inclusion. Psychiatric symptoms were moderate at baseline and declined in both groups after 10 weeks (d = 0.57–0.75). No between-group effects over time occurred on depression (b = 0.3 [95% CI −1.6, 2.2]; d = 0.06), anxiety (b = −0.7 [−2.5, 1.2]; d = 0.13), or lifestyle behaviors (b = 0.01 [−0.3, 0,3]; d = −0.01). Conclusions: Recruitment routines seemed to be decisive for reaching as many patients as possible. The relatively low rate of unhealthy lifestyle behaviors and small effect sizes suggests that the intervention may only suit patients at risk. Trial registration: ClinicalTrials.gov NCT03691116 (01/10/2018), focusing on the embedded trial. Retrospectively registered for the first clinic and prospectively for the second clinic. [ABSTRACT FROM AUTHOR]