Eligibility criteria

General practices have to be located in the Capital Region of Denmark and the Region of Zealand. General practices without permanent staff, so-called regional clinics or clinics run by private firms, are not included due to lack of continuity of care, which is assumed to be a critical underlying component of the hypothesized effect of the intervention. General practices that have participated recently or still participate in trials similar to the SOFIA trial will be excluded. No other in- or exclusion criteria will be applied when recruiting general practices.

General practices will be invited to participate by the research team. More than one general practitioner may be employed at a single practice. To participate in the trial, all general practitioners employed at a practice should agree to participate. We aim to recruit 6 general practices in the Capital Region and 6 general practices in Region Zealand. Each Region is divided into multiple municipalities. We aim to recruit practices from different municipalities to increase the generalizability of the pilot study to inform the feasibility of a larger-scale RCT. Practices are recruited via telephone, followed by an email with information about the study and a further telephone call in which practices confirm or decline participation. General practices confirming interest in participating in the study will be visited by members of the research team. During this visit, practices will be provided instructions and materials for recruitment of patients, data collection, and any other information needed to conduct the trial.

Patients will be included if they:

A. Are aged 18 and over on the day of inclusion of the general practice

And

B1. Have a psychotic disorder

[Registered at general practice with International Classification of Primary Care version 2 (ICPC-2) psychiatric diagnosis p72 (psychotic disorders) which roughly corresponds to International Classification of Diseases 10 (ICD-10) codes F20-F29.9]

Or

B2. Have a bipolar disorder

[Registered at general practice with ICPC-2 diagnosis of p73, bipolar mood disorders, roughly corresponding to ICD-10 codes F30-F31, and F34.0; Or have a prescription of lithium (Anatomical Therapeutic Chemical classification (ATC) N05AN); Or are registered at general practice with ICPC-2 diagnosis p76, unipolar depressive disorders, roughly corresponding to ICD-10 codes F32.2 - F32.3, and/or F33.2- F33.3, and F53.0; And have a prescription of Lamotrigine (N03AX09) and/or Carbamazepine (N03AF01) and/or Valproic acid (N03AG01)]

Or

B3. Have a severe depressive disorder.

[Registered at general practice with ICPC-2 diagnosis p76, unipolar depressive disorders roughly corresponding to ICD-10 codes F32.2 - F32.3, and/or F33.2- F33.3, and F53.0; And have a prescription of tricyclic antidepressants (ATC: N06AA) and/or Selective Norepinephrine Receptor Inhibitors (SNRI) venlafaxine (N06AX16) and duloxetine (N06AX21) and/or Monoamine Oxidase A Inhibitor (MAOI) (N06AG) and/or non-selective MAOI (N06AF).]

Patients will be excluded from participation if they are:

Subjected to any type of legal measure as stipulated in the Danish Mental Health Care Act (Psykiatriloven), e.g., forced detention or medication;

Registered with a dementia diagnosis ICPC-2 p70, roughly corresponding to ICD-10 F0.01-0.03 or registered with organic psychosyndrome or other neurological diseases (ICPC-2 P71, N73, N99)

Receiving end-of-life care

Non-Danish speakers

Psychiatric diagnosis appears to be incorrect or outdated

Assumed by the patient’s general practitioner to have an overall functional level that is too low for meaningful participation in the trial (use of this criterion will be evaluated on an individual basis by the trial management team to minimize the risk of selective inclusion).

Participating practices will be instructed to collect the International Classification of Primary Care version 2 (ICPC-2) codes and ATC-codes from the electronic medical record on all patients who are registered at the practice at the commencement of the study and send these to the research team. ICPC-2 codes are routinely used in Danish medical practice.

A computer algorithm will randomly select a sample of 45 patients who fulfill the externally verifiable inclusion criteria for each participating general practice. This selection will be stratified, in that each sample of 45 patients includes 15 patients who meet diagnostic criteria B1, B2, or B3 respectively. The research team sends this list of 45 potentially eligible patients to the general practitioners. General practitioners are instructed to screen these lists for correct diagnoses. In case of uncertainty regarding diagnosis, general practitioners should contact the research team. When a diagnosis is verified by the general practitioner, the general practitioner will assess the eligibility of the listed patients according to the exclusion criteria described above. General practitioners are instructed to document any reasons for exclusions and any reasons for deviating from the exclusion criteria. General practitioners are instructed to recruit at least 2 patients from each diagnostic subgroup (corresponding to the inclusion criteria B1, B2, and B3). We employ a reimbursement limit of 15 patients per practice. Patients participating in the study will not receive financial compensation.

The general practices will establish the initial contact with patients who were found eligible. Practice staff will contact potentially eligible patients via telephone, and provide brief oral information about the study. When approaching patients, practice personnel are instructed to register the date and means of contact, e.g., telephone or email, and the number of attempts. In case the patient does not respond, an email, text message, or message on voicemail is sent. If a patient cannot be reached after at least three attempts, the patient will be excluded from participation. Patients, who express interest in participating in the study, will be invited to an initial 10–30-min enrolment visit at the general practice. General practices are instructed by the research team to send an information leaflet and a copy of the informed consent form by mail or email to patients before they visit their practice. During the enrolment visit, further questions regarding the study will be discussed. If patients agree to participate, written informed consent will be obtained. Moreover, all patients receive the questionnaires MMQ and the EQ-5D-5L measuring quality of life and health status after they visited their practice. Patients can either choose to receive the questionnaire in print from their general practice or via their e-Boks (provider of secure platforms and digital post-boxes) from the research team. A more detailed description of the properties of these questionnaires is provided below in the section “Data collection before randomization”—quality of life measurements. Patients are asked by the general practitioner to complete these questionnaires online through a link in their secured email or return them by mail in a prepaid envelop to the research team.