Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice

Ischemic Heart Disease Clinical Trial

Official title:

Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05611112
• Other study ID #: PST
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: November 2023
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 188
• Est. completion date: March 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• +18 years

• Diagnosed with ischemic heart disease and/or type 2 diabetes

• Poor mental health defined as WHO-5 well-being index <50 points

Exclusion Criteria:

• severe mental illness including psychotic disease and suicidal behaviour

• unable to read and understand Danish

Related Conditions & MeSH terms

• Chronic Disease
• Coronary Artery Disease
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Heart Diseases
• Ischemic Heart Disease
• Mental Health Impairment
• Myocardial Ischemia

Intervention

Behavioral:
• Problem Solving Therapy
Problem Solving Therapy is a well-established evidence-based therapy form that is highly effective in patients with mental health issues. Initially, the patient makes a problem list and for each problem, possible solutions will be outlined. Considering pros and cons for each solution, the patient is asked to choose the one considered most appropriate. The patient is encouraged to put this solution into action and a follow-up consultation is planned.

Locations

Country	Name	City	State
Denmark	Research unit for general practice	Aarhus

Sponsors (5)

Lead Sponsor	Collaborator
University of Aarhus	Central Denmark Region, Danish Heart Foundation, Research Unit for General Practice, Aarhus University, TrygFonden, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mental health - Depression	Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up	12 months
Secondary	Mental health - Anxiety	General Anxiety Disorder-7 (GAD-7) 12 months of follow-up	12 months
Secondary	Mental health - Anxiety	General Anxiety Disorder-7 (GAD-7) 6 months of follow-up	6 months
Secondary	Diabetes related stress	Problem Areas in Diabetes-5 (PAID-5) at 12 months of follow-up	12 months
Secondary	Mental health - Depression	Patient Health Questionnaire-9 (PHQ-9) at 6 months of follow-up	6 months
Secondary	Prescriptions of psychopharmacological medications	Prescriptions of psychopharmacological medications during one year after start of patient-inclusion. Register-based.	12 months
Secondary	Medication adherence	Changes in medication adherence to antidiabetic drugs and statins	Baseline and 12 months
Secondary	Lipid profile	Changes in lipid profile (from blod samples)	Baseline and 12 months
Secondary	Blood pressure	Changes in blod pressure	Baseline and 12 months
Secondary	Smoking status	Changes in smoking status	Baseline and 12 months
Secondary	Use of health care services	Changes in use of health care services including any contacts to general practice, out-of-hours medical service, cardiovascular readmissions and all cause hospitalizations	Baseline and 12 months
Secondary	Health literacy	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.	Baseline