NCT07263321Toboroz
Improving Treatment for Depression in General Practice Using a Step-by-Step Care Plan.
Optimising Treatment for Patients With Depressive Episodes in General Practice Through Algorithm-Based Treatment: A Randomised, Open-label Controlled Trial.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. dec. 10.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 171 (tervezett)
- Első benyújtás
- 2025. nov. 20.
- Kezdés
- 2025. dec.
- Elsődleges befejezés
- 2027. jún.
- Fő szponzor
- Aalborg University Hospital
- Betegségek
- Depresszió
- NCT-szám
- NCT07263321
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 171
- 2025. dec. és az elsődleges befejezés (2027. jún.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- No current medical or psychotherapy treatment initiated within the last 4 weeks prior to screening.
Más betegség
- A diagnosis of dementia.
- Medical conditions that might interfere with the study outcome or safety, judged so by the investigator.
Egyéb
- Misuse of substances that might influence the study, as judged by the investigator.
- Difficulty in understanding the Danish language, as judged 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Aalborg University Hospital, Department of Psychiatry | Aalborg | Dánia | Toboroz |
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