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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAalborg University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Algorithm-Based Treatment

    Other intervention

    This is an open-label pharmacological intervention.

  • Treatment as usual (TAU)

    Other intervention

    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.

  • Treatment as usual (TAU)

    Other intervention

    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.

Treatment groups

171 Participants
are divided into 3 treatment groups
Group A: Treatment as usual by a general practitioner (TAU-GP).Other 1 intervention
Group B: Treatment as usual by a psychologist (TAU-P).Other 1 intervention
Group C: Algorithm-based pharmacological treatment by a general practitioner (ALGO).Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The Hamilton Rating Scale for Depression, 6 item version (HAM-D6)

Time frame
From enrollment to the end of treatment at 12 weeks.

Secondary outcomes

1

The Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame
From enrollment to the end of treatment at 12 weeks.
2

The Major Depression Inventory (MDI)

Time frame
From enrollment to the end of treatment at 12 weeks.
3

The Personal and Social Performance Scale (PSP)

Time frame
From enrollment to the end of treatment at 12 weeks
4

The Danish Adult Reading Test (DART)

Time frame
At enrollment

Other outcomes

Sponsors and contacts

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