Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention.

BACKGROUND: Mental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortality. Problem-solving therapy (PST) may be a suitable treatment for targeting poor mental health in these patients. This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being. METHODS: A stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offered treatment with PST provided by general practitioners (GPs) or general practice staff, such as nurses, who will undergo a 2-day PST course before transitioning from the control to the intervention group. The primary outcome is change in depressive symptoms after 6 and 12 months. Secondary outcomes include change in mental well-being, anxiety, and diabetes distress (patients with type 2 diabetes) after 6 and 12 months as well as change in total cholesterol levels, low-density lipoprotein (LDL) levels, and blood glucose levels (patients with diabetes) after 12 months. Process outcomes include measures of implementation and mechanisms of impact. We aim to include a total of 188 patients, corresponding to approximately 14 average-sized general practices. DISCUSSION: The Healthy Mind trial investigates the impact of PST treatment for patients with chronic disease and poor mental well-being in general practice. This will be the first randomised controlled trial determining the effect of PST treatment for patients with chronic diseases in general practice. The results of this study will provide relevant insights to aid GPs, and general practice staff manage patients with poor mental well-being. TRIAL REGISTRATION: ClinicalTrials.gov NCT05611112. Registered on October 28, 2022.

The Brief Health Literacy Scale for Adults: Adaptation and Validation of the Health Literacy for School-Aged Children Questionnaire.

The Health Literacy for School-Aged Children (HLSAC) is a brief, generic instrument measuring health literacy among school-aged children. Given its brevity and broad conceptualization of health literacy, the HLSAC is a potentially valuable measuring instrument among adults as well. This validation study aimed to adapt the HLSAC questionnaire to an adult population through assessment of content validity and subsequently determine the structural validity of the adapted instrument, the Brief Health Literacy scale for Adults (B-HLA). The content validity of the HLSAC was assessed through interviews with respondents and experts, and the structural validity of the adapted instrument (B-HLA) was evaluated using Rasch analysis. The content validity assessment (n = 25) gave rise to adjustments in the wording of five items. The B-HLA demonstrated an overall misfit to the Rasch model (n = 290). Items 6 and 8 had the poorest individual fits. We found no signs of local dependency or differential item functioning concerning sex, age, education, and native language. The B-HLA demonstrated unidimensionality and ability to discriminate across health literacy levels (PSI = 0.80). Discarding items 6 or 8 resulted in an overall model fit and individual fit of all items. In conclusion, the B-HLA appears to be a valid and reliable instrument for assessing health literacy among adults.