History of Changes for Study: NCT05611112

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

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Study Record Versions

Version	Submitted Date	Changes
1	November 3, 2022	None (earliest Version on record)
2	November 30, 2023	Recruitment Status, Study Status, Contacts/Locations, Study Design, Study Description and Oversight
3	May 8, 2024	Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	PST
Brief Title:	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
Secondary IDs:

Study Status


Record Verification:	October 2022
Overall Status:	Not yet recruiting
Study Start:	November 1, 2022
Primary Completion:	February 14, 2024 [Anticipated]
Study Completion:	February 14, 2024 [Anticipated]

First Submitted:	October 28, 2022
First Submitted that Met QC Criteria:	November 3, 2022
First Posted:	November 9, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	November 3, 2022
Last Update Posted:	November 9, 2022 [Actual]

Sponsor/Collaborators


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

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:

Study Description

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 194 patients with IHS and 194 patients with T2D (we expect 25% overlap) to obtain a power of 90%.

Conditions


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

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Sequential Assignment
	Stepped wedge cluster-randomised controlled trial with a one-year follow-up.
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	470 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

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.

Outcome Measures


Primary Outcome Measures:
1.	Mental health - Depression [ Time Frame: 12 months ] Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up
Secondary Outcome Measures:
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.

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
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

Contacts/Locations


Central Contact Person:	Bo Christensen, Professor, MD Telephone: +4521766695 Email: bc@ph.au.dk
Central Contact Backup:	Stinne Rasmussen, MD Telephone: +4540197165 Email: stinne.e.rasmussen@ph.au.dk
Locations:

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: