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

University of Aarhus

Status: Active, not recruiting

Conditions: Ischemic Heart Disease; Mental Health Impairment; Diabetes Type 2

Treatments: Behavioral: Problem Solving Therapy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05611112

PST

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 188 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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188 participants in 2 patient groups

Control

No Intervention group

Description:

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.

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Problem Solving Therapy