Evidence map›Paper›PMID 38654329›Full record

ArticleTrials2024

Improving mental health in chronic care in general practice: study protocol for a cluster-randomised controlled trial of the Healthy Mind intervention.

Anne Søjbjerg, Anna Mygind, Stinne Eika Rasmussen, Bo Christensen, Anette Fischer Pedersen, Helle Terkildsen Maindal, Viola Burau, Kaj Sparle Christensen

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05611112 (Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 39% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05611112 nacompletednot on this map

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

TypeinterventionalSponsorUniversity of AarhusRan2022 to 2025Enrolled147ConditionsMental Health Impairment, Diabetes Type 2, Ischemic Heart DiseaseArmsProblem Solving Therapy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

Anne SøjbjergResearch Unit for General Practice, Bartholins Allé 2, 8000, Aarhus C, Denmark. annsoj@ph.au.dk.ORCID http://orcid.org/0009-0005-2707-8451
Anna MygindResearch Unit for General Practice, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Stinne Eika RasmussenResearch Unit for General Practice, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Bo ChristensenResearch Unit for General Practice, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Anette Fischer PedersenResearch Unit for General Practice, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Helle Terkildsen MaindalDepartment of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Viola BurauDepartment of Public Health, Aarhus University, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Kaj Sparle ChristensenResearch Unit for General Practice, Bartholins Allé 2, 8000, Aarhus C, Denmark.
Aarhus University · DK

Funding

Hjerteforeningen 21-R152-A9866-22186Kvalitets og efteruddannelses udvalget i Region Midt (KEU) 1-30-72-47-22Multipraksisudvalget (MPU) 1388660Praksisforskningsfonden 1-01-72-19-16
6 · The paper itself

Abstract

backgroundMental health issues are common among patients with chronic physical conditions, affecting approximately one in five patients. Poor mental health is associated with worse disease outcomes and increased mortality. Problem-solving therapy (PST) may be a suitable treatment for targeting poor mental health in these patients. This study protocol describes a randomised controlled trial of the Healthy Mind intervention, a general practice-based intervention offering PST to patients with type 2 diabetes and/or ischaemic heart disease and poor mental well-being.

methodsA stepped-wedge cluster-randomised controlled trial with 1-year follow-up will be conducted in Danish general practice. At the annual chronic care consultation, patients with type 2 diabetes and/or chronic ischaemic heart disease will be screened for poor mental well-being. Patients in the control group will be offered usual care while patients in the intervention group will be offered treatment with PST provided by general practitioners (GPs) or general practice staff, such as nurses, who will undergo a 2-day PST course before transitioning from the control to the intervention group. The primary outcome is change in depressive symptoms after 6 and 12 months. Secondary outcomes include change in mental well-being, anxiety, and diabetes distress (patients with type 2 diabetes) after 6 and 12 months as well as change in total cholesterol levels, low-density lipoprotein (LDL) levels, and blood glucose levels (patients with diabetes) after 12 months. Process outcomes include measures of implementation and mechanisms of impact. We aim to include a total of 188 patients, corresponding to approximately 14 average-sized general practices. DISCUSSION: The Healthy Mind trial investigates the impact of PST treatment for patients with chronic disease and poor mental well-being in general practice. This will be the first randomised controlled trial determining the effect of PST treatment for patients with chronic diseases in general practice. The results of this study will provide relevant insights to aid GPs, and general practice staff manage patients with poor mental well-being.

trial registrationClinicalTrials.gov NCT05611112. Registered on October 28, 2022.

Indexed as

Diabetes Mellitus, Type 2General PracticeMental HealthRandomized Controlled Trials as TopicAnxietyChronic DiseaseDenmarkDepressionHumansMyocardial IschemiaProblem SolvingTime FactorsTreatment OutcomeChronic diseaseDiabetes mellitusGeneral practiceGeneral practitionersHeart diseasesMental healthNursesPrimary healthcareProblem-solving therapyPsychosocial interventionRandomised controlled trial (publication type)Type 2

Identifiers

PMID38654329
PMCPMC11036681
OpenAlexW4395044045

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.