Clinical trial NCT05611112: Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice
Official title: Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Impairment
Diabetes Type 2
Ischemic Heart Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Research Unit for General Practice, Aarhus University
name: Danish Heart Foundation
name: TrygFonden, Denmark
name: Central Denmark Region
First posted: 2022-11-09
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster-randomised controlled trial with a one-year follow-up.
Primary purpose: TREATMENT

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Mental health - Depression
timeFrame: 12 months
Secondary outcomes:
measure: Mental health - Anxiety
timeFrame: 12 months
measure: Mental health - Anxiety
timeFrame: 6 months
measure: Diabetes related stress
timeFrame: 12 months
measure: Mental health - Depression
timeFrame: 6 months
measure: Prescriptions of psychopharmacological medications
timeFrame: 12 months
measure: Medication adherence
timeFrame: Baseline and 12 months
measure: Lipid profile
timeFrame: Baseline and 12 months
measure: Blood pressure
timeFrame: Baseline and 12 months
measure: Smoking status
timeFrame: Baseline and 12 months
measure: Use of health care services
timeFrame: Baseline and 12 months
measure: Health literacy
timeFrame: Baseline
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Research unit for general practice
Study officials:
References: