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NCT Number: NCT05611112

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.

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Key information

Conditions

Mental Health Impairment Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Ischemic Heart Disease Metabolic Diseases Myocardial Ischemia Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research unit for general practice

Aarhus, 8000, Denmark

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Problem solving therapy

Behavioral

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.

Primary outcomes

  1. Mental health - Depression

    Time frame: 12 months

    Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up

Secondary outcomes

  1. Mental health - Anxiety

    Time frame: 12 months

    General Anxiety Disorder-7 (GAD-7) 12 months of follow-up

  2. Mental health - Anxiety

    Time frame: 6 months

    General Anxiety Disorder-7 (GAD-7) 6 months of follow-up

  3. Diabetes related stress

    Time frame: 12 months

    Problem Areas in Diabetes-5 (PAID-5) at 12 months of follow-up

  4. Mental health - Depression

    Time frame: 6 months

    Patient Health Questionnaire-9 (PHQ-9) at 6 months of follow-up

  5. Prescriptions of psychopharmacological medications

    Time frame: 12 months

    Prescriptions of psychopharmacological medications during one year after start of patient-inclusion. Register-based.

  6. Medication adherence

    Time frame: Baseline and 12 months

    Changes in medication adherence to antidiabetic drugs and statins

  7. Lipid profile

    Time frame: Baseline and 12 months

    Changes in lipid profile (from blod samples)

  8. Blood pressure

    Time frame: Baseline and 12 months

    Changes in blod pressure

  9. Smoking status

    Time frame: Baseline and 12 months

    Changes in smoking status

  10. Use of health care services

    Time frame: 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

  11. Health literacy

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region
  • Danish Heart Foundation
  • Research Unit for General Practice, Aarhus University
  • TrygFonden, Denmark

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Nov 9, 2022
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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