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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease; Mental Health Impairment; Diabetes Type 2
• Intervention / Treatment: Behavioral: Problem Solving Therapy

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%.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Research unit for general practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients in the control group will have unrestricted access to care as usually provided. No restrictions are imposed on the general practitioners (GPs) regarding treatment of patients with mental health problems, as we are interested in assessing the added value of PST in routine clinical practice. In both groups, GPs are recommended to follow the current guidelines.
Experimental: Intervention; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health - Depression	Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health - Anxiety	General Anxiety Disorder-7 (GAD-7) 12 months of follow-up	12 months
Mental health - Anxiety	General Anxiety Disorder-7 (GAD-7) 6 months of follow-up	6 months
Diabetes related stress	Problem Areas in Diabetes-5 (PAID-5) at 12 months of follow-up	12 months
Mental health - Depression	Patient Health Questionnaire-9 (PHQ-9) at 6 months of follow-up	6 months
Prescriptions of psychopharmacological medications	Prescriptions of psychopharmacological medications during one year after start of patient-inclusion. Register-based.	12 months
Medication adherence	Changes in medication adherence to antidiabetic drugs and statins	Baseline and 12 months
Lipid profile	Changes in lipid profile (from blod samples)	Baseline and 12 months
Blood pressure	Changes in blod pressure	Baseline and 12 months
Smoking status	Changes in smoking status	Baseline and 12 months
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
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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Central Denmark Region; Research Unit for General Practice, Aarhus University; TrygFonden, Denmark; Danish Heart Foundation

Publications and helpful links

General Publications

• Sojbjerg A, Mygind A, Rasmussen SE, Christensen B, Pedersen AF, Maindal HT, Burau V, Christensen KS. Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention. Trials. 2024 Apr 23;25(1):277. doi: 10.1186/s13063-024-08115-8.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): September 1, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 3, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Myocardial Ischemia
• Other Study ID Numbers: PST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No