Mental Health ImpairmentNCT05611112
Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice
A study testing Problem Solving Therapy in people with Mental Health Impairment and Diabetes Type 2, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health Impairment, Diabetes Type 2, Ischemic Heart Disease
- What is being tested?
- Problem Solving Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2022to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- +18 years
- Diagnosed with ischemic heart disease and/or type 2 diabetes
- Poor mental health defined as WHO-5 well-being index <50 points
Who cannot join
- severe mental illness including psychotic disease and suicidal behaviour
- unable to read and understand Danish
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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%.
- Being tested
- Problem Solving Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving TherapyBehavioural
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 group | Role | What they receive |
|---|---|---|
| Control | No intervention | 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 | 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. Receives: Behavioral: Problem Solving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health - Depression
Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up
Measured: 12 months
Secondary outcomes (11)
Mental health - Anxiety
General Anxiety Disorder-7 (GAD-7) 12 months of follow-up
Measured: 12 months
Mental health - Anxiety
General Anxiety Disorder-7 (GAD-7) 6 months of follow-up
Measured: 6 months
Diabetes related stress
Problem Areas in Diabetes-5 (PAID-5) at 12 months of follow-up
Measured: 12 months
Mental health - Depression
Patient Health Questionnaire-9 (PHQ-9) at 6 months of follow-up
Measured: 6 months
Prescriptions of psychopharmacological medications
Prescriptions of psychopharmacological medications during one year after start of patient-inclusion. Register-based.
Measured: 12 months
Medication adherence
Changes in medication adherence to antidiabetic drugs and statins
Measured: Baseline and 12 months
Lipid profile
Changes in lipid profile (from blod samples)
Measured: Baseline and 12 months
Blood pressure
Changes in blod pressure
Measured: Baseline and 12 months
Smoking status
Changes in smoking status
Measured: Baseline and 12 months
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
Measured: Baseline and 12 months
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Sep 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped wedge cluster-randomised controlled trial with a one-year follow-up.
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, Danish Heart Foundation, TrygFonden, Denmark, Central Denmark Region
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611112
- Sponsor's protocol ID
- PST
- Status last verified
- Dec 2024
- First submitted
- 28 Oct 2022
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sojbjerg A, Mygind A, Rasmussen SE, Christensen B, Pedersen AF, Maindal HT, Burau V, Christensen KS. Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention. Trials. 2024 Apr 23;25(1):277. doi: 10.1186/s13063-024-08115-8.
PubMed 38654329
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice
- ClinicalTrials.gov ID
- NCT05611112
- Acronym / sponsor ID
- PST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Research Unit for General Practice, Aarhus University, Danish Heart Foundation, TrygFonden, Denmark, Central Denmark Region
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped wedge cluster-randomised controlled trial with a one-year follow-up.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –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 | Behavioral: Problem Solving TherapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- +18 years
- Diagnosed with ischemic heart disease and/or type 2 diabetes
- Poor mental health defined as WHO-5 well-being index <50 points
Key exclusion criteria (2 listed)
- severe mental illness including psychotic disease and suicidal behaviour
- unable to read and understand Danish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem Solving TherapyProblem 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. | Behavioural | Intervention |
Primary outcome
Mental health - Depression
Time frame: 12 months
Patient Health Questionnaire-9 (PHQ-9) at 12 months of follow-up
11 secondary outcomes
Mental health - Anxiety
Time frame: 12 months
Mental health - Anxiety
Time frame: 6 months
Diabetes related stress
Time frame: 12 months
Mental health - Depression
Time frame: 6 months
Prescriptions of psychopharmacological medications
Time frame: 12 months
Medication adherence
Time frame: Baseline and 12 months
Lipid profile
Time frame: Baseline and 12 months
Blood pressure
Time frame: Baseline and 12 months
Smoking status
Time frame: Baseline and 12 months
Use of health care services
Time frame: Baseline and 12 months
Health literacy
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Derived from this study: PubMed 38654329Sojbjerg A, Mygind A, Rasmussen SE, Christensen B, Pedersen AF, Maindal HT, Burau V, Christensen KS. Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention. Trials. 2024 Apr 23;25(1):277. doi: 10.1186/s13063-024-08115-8.
- Individual participant dataSharing planned: No
Related trials for Mental Health Impairment
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy in people with Mental Health Impairment and Diabetes Type 2, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health - Depression (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611112, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.