Problem-Solving Therapy for Patients With Chronic Disease and Poor Mental Well-being in General Practice
NCT ID: NCT05611112
Last Updated: 2024-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
188 participants
INTERVENTIONAL
2022-11-01
2025-03-01
Brief Summary
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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
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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%.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with ischemic heart disease and/or type 2 diabetes
* Poor mental health defined as WHO-5 well-being index \<50 points
Exclusion Criteria
* unable to read and understand Danish
18 Years
ALL
No
Sponsors
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Research Unit for General Practice, Aarhus University
OTHER
Danish Heart Foundation
OTHER
TrygFonden, Denmark
INDUSTRY
Central Denmark Region
OTHER
University of Aarhus
OTHER
Responsible Party
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Locations
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Research unit for general practice
Aarhus, , Denmark
Countries
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References
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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.
Other Identifiers
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PST
Identifier Type: -
Identifier Source: org_study_id