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Completed

NCT Number: NCT02678845

Project Collabri for Treatment of Depression

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Centre Copenhagen

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment according to the Collabri model

Other

The Collabri Model is a complex intervention and consists of a number of treatment modalities. The Collabri Model includes the following elements: A multi-professional approach to treatment including a care manager, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. It further integrates: Recruitment of staff with psychiatric experience, training of general practitioner and care manager, use of instruments for detection and follow-up, education and treatment of the patient, supervision from a psychiatric specialist, guided self-help, patient- and relative involvement and a stepped care approach to treatment where treatment is always commenced on the least invasive and least resource-demanding level.

Primary outcomes

  1. Degree of depression measured by the Beck Depression Inventory (BDI)

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

Secondary outcomes

  1. Degree of anxiety measured by the Beck Anxiety Inventory (BAI)

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  2. Psychological stress measured with the Symptom Checklist (SCL-92)

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  3. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)

    Time frame: At 6 months follow up after baseline

    The measure is obtained through a semi-structured interview

Other outcomes

  1. Degree of depression measured by the Beck Depression Inventory (BDI)

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  2. Degree of anxiety measured by the Beck Anxiety Inventory (BAI)

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  3. Psychological stress measured with the Symptom Checklist (SCL-92)

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  4. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)

    Time frame: At 15 months follow up after baseline

    The measure is obtained through a semi-structured interview

  5. Quality of life measured with the WHO-5

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  6. Quality of life measured with the WHO-5 scale

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  7. Personal and social performance measured with the Personal and Social Performance scale (PSP)

    Time frame: At 6 months follow up after baseline

    The measure is obtained through a semi-structured interview

  8. Personal and social performance measured with the Personal and Social Performance scale (PSP)

    Time frame: At 15 months follow up after baseline

    The measure is obtained through a semi-structured interview

  9. Side effects measured by the PRISE questionnaire

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  10. Side effects measured by the PRISE questionnaire

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  11. Health-related quality of life measured with the EQ-5D

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  12. Health-related quality of life measured with the EQ-5D

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  13. Functional impairment measured with Sheehan Disability Scale (SDS)

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  14. Functional impairment measured with Sheehan Disability Scale (SDS)

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  15. Sick leave

    Time frame: At 6 months follow up after baseline

    The measure is obtained from the Danish DREAM database

  16. Sick leave

    Time frame: At 15 months follow up after baseline

    The measure is obtained from the Danish DREAM database

  17. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  18. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  19. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  20. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  21. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)

    Time frame: At 6 months follow up after baseline

    The measure is self-reported

  22. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)

    Time frame: At 15 months follow up after baseline

    The measure is self-reported

  23. Apathia

    Time frame: At 6 months follow up after baseline

    The measure is obtained through a semi-structured interview

  24. Apathia

    Time frame: At 15 months follow up after baseline

    The measure is obtained through a semi-structured interview

Sponsors and collaborators

Lead sponsor

Amager Hospital

Other

Registry information

Official study title

Project Collabri. The Effect of a Collaborative Care Model for Treatment of Depression in Primary Care in Denmark - A Cluster Randomized Clinical Superiority Trial

Important dates

Study start
2014
Primary completion
2017
Study completion
2020
First posted
Feb 10, 2016
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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