Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice
- Conditions
- Diabetes Type 2Ischemic Heart DiseaseMental Health Impairment
- Interventions
- Behavioral: Problem Solving Therapy
- Registration Number
- NCT05611112
- Lead Sponsor
- University of Aarhus
- Brief Summary
In Denmark the vast majority of patients with chronic ischemic heart disease and/or type 2 diabetes are managed in general practice. 20% of the patients suffer from poor mental health.
Problem-solving therapy (PST) is a psychotherapeutic method that is proven effective in adults with poor mental health. PST can be provided in general practice.
The main objective of this study is to test effectiveness of providing PST to this group patients.
- Detailed Description
20% of patients with type 2 diabetes and/or chronic ischemic heart disease have poor mental health. Since these patients are managed in general practice interventions targeting poor mental health in these patients should be delivered in here.
Problem-solving therapy (PST) is a well-established psychotherapeutic method that can be delivered by health care providers in general practice.
The main objective of this study is to test the effectiveness of delivering PST for patients with T2D and/or IHS who suffer from poor mental health. We hypothesize that the patients' mental health will be improved after treatment with PST.
Health care providers from 12 general practices are trained in PST and subsequently provide PST for patients with T2D and/or IHS and poor mental health.
Patients are recruited at the annual control visit for the chronic disease. All patients are screened for impaired mental health with the WHO-5 questionnaire. Patients with a score below 50 are offered PST.
The study is conducted as a stepped wedge cluster-randomised controlled trial with a one-year follow-up. In this design clusters are stepped wise exposed to the intervention. Initially all general practices are in the control group. After four months half of the recruited GPs attend the PST training programme and switch to performing the intervention. After an additional four months the remaining GPs are educated in PST and all GPs now perform the intervention. Both general practitioners and practise nurses will perform PST consultations.
The power calculation is based on:
* The primary outcome (PHQ-9 score at 6 and 12 months. The minimal clinical effect is 5 points)
* ICC is estimated to 0,05.
Based on these assumptions we will include 188 patients with IHS or/and T2D (we expect 25% overlap) to obtain a power of 90%.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 188
- +18 years
- Diagnosed with ischemic heart disease and/or type 2 diabetes
- Poor mental health defined as WHO-5 well-being index <50 points
- severe mental illness including psychotic disease and suicidal behaviour
- unable to read and understand Danish
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention Problem Solving Therapy Patients with type 2 diabetes and/or chronic ischemic heart disease are offered up to seven problem solving therapy sessions within a three-month period from inclusion. In both groups, GPs are recommended to follow the current guidelines.
- Primary Outcome Measures
Name Time Method Mental health - Depression 12 months Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up
- Secondary Outcome Measures
Name Time Method Smoking status Baseline and 12 months Changes in smoking status
Mental health - Anxiety 6 months General Anxiety Disorder-7 (GAD-7) 6 months of follow-up
Lipid profile Baseline and 12 months Changes in lipid profile (from blod samples)
Blood pressure Baseline and 12 months Changes in blod pressure
Medication adherence Baseline and 12 months Changes in medication adherence to antidiabetic drugs and statins
Diabetes related stress 12 months Problem Areas in Diabetes-5 (PAID-5) at 12 months of follow-up
Mental health - Depression 6 months Patient Health Questionnaire-9 (PHQ-9) at 6 months of follow-up
Prescriptions of psychopharmacological medications 12 months Prescriptions of psychopharmacological medications during one year after start of patient-inclusion. Register-based.
Health literacy Baseline Data on health literacy will be collected at baseline using the HLSAC instrument (Health Literacy for School-Aged Children), which allows the calculation of a health literacy summary score used to examine health literacy levels. HLSAC is currently being validated among adults. The summary score is between 10-40 points: 10-25 points indicates low health literacy, 26-35 points indicates moderate health literacy, 26-40 points indicates high health literacy.
Use of health care services Baseline and 12 months Changes in use of health care services including any contacts to general practice, out-of-hours medical service, cardiovascular readmissions and all cause hospitalizations
Trial Locations
- Locations (1)
Research unit for general practice
🇩🇰Aarhus, Denmark