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

NCT05611112 | Active Not Recruiting

• 1 other identifier: PST
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Impairment; Diabetes Type 2; Ischemic Heart Disease

Outcome Measures

Primary Outcomes (1)

• Mental health - Depression

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

  12 months

Secondary Outcomes (11)

• Mental health - Anxiety

  12 months

• Mental health - Anxiety

  6 months

• Diabetes related stress

  12 months

• Mental health - Depression

  6 months

• Prescriptions of psychopharmacological medications

  12 months

Study Arms (2)

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.

Behavioral: Problem Solving Therapy

Interventions

Problem Solving Therapy BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• +18 years
• Diagnosed with ischemic heart disease and/or type 2 diabetes
• Poor mental health defined as WHO-5 well-being index \<50 points

You may not qualify if:

• severe mental illness including psychotic disease and suicidal behaviour
• unable to read and understand Danish

Sponsors & Collaborators

• University of Aarhus: lead
• Research Unit for General Practice, Aarhus University: collaborator
• Danish Heart Foundation: collaborator
• TrygFonden, Denmark: collaborator
• Central Denmark Region: collaborator

Study Sites (1)

Research unit for general practice

Aarhus, 8000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38654329 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Stepped wedge cluster-randomised controlled trial with a one-year follow-up.

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 9, 2022
• Study Start: November 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)