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

TY - JOUR

T1 - Improving mental health in chronic care in general practice

T2 - study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention

AU - Søjbjerg, Anne

AU - Mygind, Anna

AU - Rasmussen, Stinne Eika

AU - Christensen, Bo

AU - Pedersen, Anette Fischer

AU - Maindal, Helle Terkildsen

AU - Burau, Viola

AU - Christensen, Kaj Sparle

N1 - © 2024. The Author(s).

PY - 2024/4

Y1 - 2024/4

N2 - 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.

AB - 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.

KW - Chronic disease

KW - Diabetes mellitus

KW - General practice

KW - General practitioners

KW - Heart diseases

KW - Mental health

KW - Nurses

KW - Primary healthcare

KW - Problem-solving therapy

KW - Psychosocial intervention

KW - Randomised controlled trial (publication type)

KW - Type 2

KW - Myocardial Ischemia/therapy

KW - Humans

KW - Depression/therapy

KW - Mental Health

KW - Anxiety/therapy

KW - Time Factors

KW - General Practice

KW - Problem Solving

KW - Treatment Outcome

KW - Randomized Controlled Trials as Topic

KW - Diabetes Mellitus, Type 2/therapy

KW - Denmark

KW - Chronic Disease

UR - http://www.scopus.com/inward/record.url?scp=85191168513&partnerID=8YFLogxK

U2 - 10.1186/s13063-024-08115-8

DO - 10.1186/s13063-024-08115-8

M3 - Journal article

C2 - 38654329

SN - 1468-6708

VL - 25

JO - Trials

JF - Trials

IS - 1

M1 - 277

ER -