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Project Collabri for Treatment of Depression

M

Mental Health Services in the Capital Region, Denmark

Status

Completed

Conditions

Depression

Treatments

Other: Treatment according to the Collabri model

Study type

Interventional

Funder types

Other

Identifiers

NCT02678845
H-3-2013-203-D

Details and patient eligibility

About

The purpose of this study is to determine whether treatment of patients with depression according to the Collabri Model is more effective in reducing symptoms compared to treatment as usual (TAU)

Full description

Background:

Depression is a common disease mostly treated in general practice. Diagnose and evidence based treatment in general practice today is not optimal (e.g. lack of continuity in disease management and lack of treatment opportunities).

International studies show effect of collaborative care on depression, but is not directly applicable into a Danish context.

A Danish model for collaborative care treatment of people with depression, generalized anxiety disorder, social phobia and panic disorder (the Collabri Model) is developed. The Collabri model consists of a multi-professional approach to treatment, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan.

Objectives:

to investigate the effect of the Collabri model for depression and further investigate two methods for detection of depression; standard detection and case finding.

Methods:

Two researcher-blinded cluster-randomized controlled studies with an intervention group (treatment according to the Collabri model) and a control group (TAU). Participants are 480 patients with depression consulting their general practitioner.

Results:

Primary outcome for the collaborative care study on depression is depression symptoms, measured with BDI at 6 months.

Discussion:

The results will contribute new knowledge on collaborative care for depression and anxiety in Danish conditions.

Enrollment

325 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age: 18+ years
  • Danish speaking
  • Diagnosis of current depression using the Mini International Neuropsychiatric Interview (MINI) (DSM IV) by researchers that have been trained in using MINI and according to the ICD-10 criteria or when diagnosed by GP after conference with a psychiatrist in Project Collabri
  • The patient has given her/his written informed consent to participate in the trial at the described terms

Exclusion criteria

  • High risk of suicide assessed in the Mini International Neuropsychiatric Interview (MINI) and/or by general practitioner
  • Psychotic condition detected in the MINI and/or by general practitioner
  • Patients with a diagnosis of dementia
  • Pregnancy
  • Alcohol or substance misuse that hinders the person participating in Collabri treatment as assessed by the practitioner or researcher at inclusion interview
  • Patients that are in current psychological or psychiatric treatment due to anxiety or depression
  • Patients with a pending disability pension case
  • Patients who have been treated for anxiety or depression within the last 6 months
  • For patients in the intervention group: Patients with depression who wants treatment cf. the Danish psychologist scheme and do not want the reference to the psychologist preceded by other treatment, cf. the Collabri model
  • For patients in the intervention group: If the patient at the first point of contact with the general practitioner after inclusion by a research assistant is referred to treatment as a part of the secondary psychiatric care system.
  • Patients who are assessed by the general practitioner as medically unstable making it impossible for the patient to adhere to treatment
  • OCD, PTSD, bipolar affective disorder as assessed in the MINI and/or by the general practitioner

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

325 participants in 2 patient groups

Treatment according to the Collabri model
Experimental group
Description:
Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder
Treatment:
Other: Treatment according to the Collabri model
Treatment as usual
No Intervention group
Description:
Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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