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Simple talk therapy shows promise for heart and diabetes Patients' mental health

NCT ID NCT05611112

Symptom relief Sponsor: University of Aarhus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested problem-solving therapy (PST) for adults with type 2 diabetes or heart disease who also have poor mental well-being. PST is a structured talk therapy where patients list their problems, weigh solutions, and take action. The trial involved 147 patients in general practice and measured depression and anxiety after 12 months. The goal was to see if this brief therapy can improve mental health in people already managing a chronic illness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Problem-solving therapy (a structured talk therapy that helps patients identify problems and choose solutions)
What this could lead to
If it works, this could offer a simple, non-drug way to improve mental well-being for people managing chronic diseases like diabetes or heart disease.
What could go wrong
This is a small, completed trial with 147 participants, so results may not apply to everyone. The therapy may not work for all patients or may have limited long-term benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

147 people

The number who actually took part.

Started

Nov 2022

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

mental disorder myocardial ischemia type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes type 2 Ischemic heart disease Mental health impairment

Contacts and locations

Locations

  • Research unit for general practice

    Aarhus, 8000, Denmark

More trials for these conditions

Other studies related to the condition(s) this trial covers.