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

Primary Purpose

Mental Health Impairment, Diabetes Type 2, Ischemic Heart Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Problem Solving Therapy
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mental Health Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 28, 2022
    Last Updated
    November 3, 2022
    Sponsor
    University of Aarhus
    Collaborators
    Research Unit for General Practice, Aarhus University, Danish Heart Foundation, TrygFonden, Denmark, Central Denmark Region
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05611112
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2022 (Anticipated)
    Primary Completion Date
    February 14, 2024 (Anticipated)
    Study Completion Date
    February 14, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus
    Collaborators
    Research Unit for General Practice, Aarhus University, Danish Heart Foundation, TrygFonden, Denmark, Central Denmark Region

    4. Oversight

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

    5. 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%.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mental Health Impairment, Diabetes Type 2, Ischemic Heart Disease

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm 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.
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm 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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Problem Solving Therapy
    Intervention Description
    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 Outcome Measure Information:
    Title
    Mental health - Depression
    Description
    Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Mental health - Anxiety
    Description
    General Anxiety Disorder-7 (GAD-7) 12 months of follow-up
    Time Frame
    12 months
    Title
    Mental health - Anxiety
    Description
    General Anxiety Disorder-7 (GAD-7) 6 months of follow-up
    Time Frame
    6 months
    Title
    Diabetes related stress
    Description
    Problem Areas in Diabetes-5 (PAID-5) at 12 months of follow-up
    Time Frame
    12 months
    Title
    Mental health - Depression
    Description
    Patient Health Questionnaire-9 (PHQ-9) at 6 months of follow-up
    Time Frame
    6 months
    Title
    Prescriptions of psychopharmacological medications
    Description
    Prescriptions of psychopharmacological medications during one year after start of patient-inclusion. Register-based.
    Time Frame
    12 months
    Title
    Medication adherence
    Description
    Changes in medication adherence to antidiabetic drugs and statins
    Time Frame
    Baseline and 12 months
    Title
    Lipid profile
    Description
    Changes in lipid profile (from blod samples)
    Time Frame
    Baseline and 12 months
    Title
    Blood pressure
    Description
    Changes in blod pressure
    Time Frame
    Baseline and 12 months
    Title
    Smoking status
    Description
    Changes in smoking status
    Time Frame
    Baseline and 12 months
    Title
    Use of health care services
    Description
    Changes in use of health care services including any contacts to general practice, out-of-hours medical service, cardiovascular readmissions and all cause hospitalizations
    Time Frame
    Baseline and 12 months
    Title
    Health literacy
    Description
    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.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Bo Christensen, Professor, MD
    Phone
    +4521766695
    Email
    bc@ph.au.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stinne Rasmussen, MD
    Phone
    +4540197165
    Email
    stinne.e.rasmussen@ph.au.dk

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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