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

• ClinicalTrials.gov Identifier: NCT05611112
• Recruitment Status: Enrolling by invitation
• First Posted: November 9, 2022
• Last Update Posted: May 9, 2024
• Sponsor: University of Aarhus
• Collaborators: Research Unit for General Practice, Aarhus University; Danish Heart Foundation; TrygFonden, Denmark; Central Denmark Region
• Information provided by (Responsible Party): University of Aarhus

Tracking Information

• First Submitted Date: October 28, 2022
• First Posted Date: November 9, 2022
• Last Update Posted Date: May 9, 2024
• Actual Study Start Date: November 1, 2022
• Estimated Primary Completion Date: September 1, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 3, 2022)

Mental health - Depression [ Time Frame: 12 months ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 3, 2022)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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%.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Stepped wedge cluster-randomised controlled trial with a one-year follow-up.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

• Mental Health Impairment
• Diabetes Type 2
• Ischemic Heart Disease

Intervention

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.

Study Arms

• 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.
  Intervention: Behavioral: Problem Solving Therapy

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: November 30, 2023): 188
• Original Estimated Enrollment (submitted: November 3, 2022): 470
• Estimated Study Completion Date: March 1, 2025
• Estimated Primary Completion Date: September 1, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT05611112
• Other Study ID Numbers: PST
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of Aarhus
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Aarhus
• Original Study Sponsor: Same as current

Collaborators

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

• Investigators: Not Provided
• PRS Account: University of Aarhus
• Verification Date: November 2023