Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.

Официальное название

Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.

Обзор

The goal of this clinical trial is to compare three different treatments for depression in patients with moderate depression in General Practice, aged 18-65 years. We wish to investigate the effect of the treatment approaches, and 171 patients will be included in the trial. The participants will be randomised to one of the following three treatments: 1. Standard treatment provided by a general practitioner (i.e. the general practitioner treats the patient as he/she would normally do, when treating a patient with depression). 2. Standard treatment provided by a psychologist in the form behavioural therapy (i.e. the psychologist treats the patient as he/she would normally do, when treating a patient with depression). 3. A step-by-step treatment plan carried out by a general practitioner. The plan includes pre-determined follow-ups and a pre-determined, structured plan for which medications to use and when to increase dose or switch medication. The hypothesis is that a structured and step-by-step treatment approach regarding patients with depression, treated in general practice, is more effective than standard treatment provided by a general practitioner and a psychologist. All the participants will: 1. Receive one of the three treatments for 12 weeks. 2. Have meetings with the project staff every 4 weeks (week 0, 4, 8 and 12) were rating scales will be completed, e.g. a rating scale to measure progress or deterioration in the participant's depression.

Вмешательства

• Другое Algorithm-Based Treatment
  This is an open-label pharmacological intervention.
• Другое Treatment as usual (TAU)
  This is a "treatment as usual" provided by a general practitioner (GP). The GP will implement a standard treatment he or she normally would use, when treating a patient with moderate depression in general practice.
• Другое Treatment as usual (TAU)
  This is a "treatment as usual" provided by a psychologist (P). The psychologist will implement Cognitive Behavioural Therapy as the standard treatment, since this is a widely used and recognised treatment strategy for patients with depression.

Первичные конечные точки

• The Hamilton Rating Scale for Depression, 6 item version (HAM-D6) [Срок оценки: From enrollment to the end of treatment at 12 weeks.]

Вторичные конечные точки (5)

• The Columbia-Suicide Severity Rating Scale (C-SSRS) [Срок оценки: From enrollment to the end of treatment at 12 weeks.]
• The Major Depression Inventory (MDI) [Срок оценки: From enrollment to the end of treatment at 12 weeks.]
• The Personal and Social Performance Scale (PSP) [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• The Danish Adult Reading Test (DART) [Срок оценки: At enrollment]
• The Brief INSPIRE-O [Срок оценки: At the end of the treatment at 12 weeks.]

Критерии участия

Критерии включения

• The participant must be referred to the study with a diagnosis of unipolar depressive disorder, as judge by the GP.
• Severity of the depressive episode corresponding to moderate depression, as judged by the GP.
• Clinical uncertainty regarding which of the treatments, medication or psychotherapy, would be the better choice in the case concerned.
• Age criteria: Participants must be at least 18 years old and no more than 65 years old at the time of randomisation.
• The participant must be a patient in general practice.
• Participants must be able to participate in virtual meetings (e.g. by phone or computer) and have e-Boks.
• The participant must be willing to receive psychotherapy by a psychologist and/or medication.
• Must have signed the document of informed consent.

Критерии исключения

• Misuse of substances that might influence the study, as judged by the investigator.
• Difficulty in understanding the Danish language, as judged by the investigator.
• A diagnosis of dementia.
• Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
• Pregnancy.
• High risk of non-adherence at the investigator's discretion.
• Suicidality: according to C-SSRS with a positive response to question 4 or 5 within the last three months or upon investigator's discretion.
• No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Aalborg University Hospital, Department of Psychiatry — Aalborg

Идентификаторы

NCT: NCT07263321 · N-20250019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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