Project Collabri for Treatment of Depression

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

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)

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Other: Treatment according to the Collabri model

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Mental Health Centre Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment according to the Collabri model; 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	Other: Treatment according to the Collabri model; 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.
No Intervention: Treatment as usual; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of depression measured by the Beck Depression Inventory (BDI)	The measure is self-reported	At 6 months follow up after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)	The measure is self-reported	At 6 months follow up after baseline
Psychological stress measured with the Symptom Checklist (SCL-92)	The measure is self-reported	At 6 months follow up after baseline
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)	The measure is self-reported	At 15 months follow up after baseline
Degree of depression measured by the Beck Depression Inventory (BDI)	The measure is self-reported	At 15 months follow up after baseline
Psychological stress measured with the Symptom Checklist (SCL-92)	The measure is self-reported	At 15 months follow up after baseline
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Quality of life measured with the WHO-5 scale	The measure is self-reported	At 15 months follow up after baseline
Personal and social performance measured with the Personal and Social Performance scale (PSP)	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline
Personal and social performance measured with the Personal and Social Performance scale (PSP)	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Side effects measured by the PRISE questionnaire	The measure is self-reported	At 6 months follow up after baseline
Side effects measured by the PRISE questionnaire	The measure is self-reported	At 15 months follow up after baseline
Health-related quality of life measured with the EQ-5D	The measure is self-reported	At 6 months follow up after baseline
Health-related quality of life measured with the EQ-5D	The measure is self-reported	At 15 months follow up after baseline
Functional impairment measured with Sheehan Disability Scale (SDS)	The measure is self-reported	At 6 months follow up after baseline
Functional impairment measured with Sheehan Disability Scale (SDS)	The measure is self-reported	At 15 months follow up after baseline
Sick leave	The measure is obtained from the Danish DREAM database	At 6 months follow up after baseline
Sick leave	The measure is obtained from the Danish DREAM database	At 15 months follow up after baseline
Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 6 months follow up after baseline
Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 15 months follow up after baseline
Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 6 months follow up after baseline
Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 15 months follow up after baseline
Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)	The measure is self-reported	At 6 months follow up after baseline
Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)	The measure is self-reported	At 15 months follow up after baseline
Apathia	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline
Apathia	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Quality of life measured with the WHO-5	The measure is self-reported	At 6 months follow up after baseline

Collaborators and Investigators

• Sponsor: Amager Hospital
• Investigators: Principal Investigator: Lene F Eplov, MD PhD, Mental Health Center Copenhagen

Publications and helpful links

General Publications

• Curth NK, Brinck-Claussen UO, Hjorthoj C, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Christensen KS, Jakobsen M, Bojesen AB, Nordentoft M, Eplov LF. Collaborative care for depression and anxiety disorders: results and lessons learned from the Danish cluster-randomized Collabri trials. BMC Fam Pract. 2020 Nov 18;21(1):234. doi: 10.1186/s12875-020-01299-3.
• Brinck-Claussen UO, Curth NK, Christensen KS, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Hjorthoj C, Nordentoft M, Eplov LF. Improving the precision of depression diagnosis in general practice: a cluster-randomized trial. BMC Fam Pract. 2021 May 7;22(1):88. doi: 10.1186/s12875-021-01432-w.
• Brinck-Claussen UO, Curth NK, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Christensen KS, Hjorthoj C, Nordentoft M, Eplov LF. Collaborative care for depression in general practice: study protocol for a randomised controlled trial. Trials. 2017 Jul 21;18(1):344. doi: 10.1186/s13063-017-2064-7.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: February 7, 2016
• First Submitted That Met QC Criteria: February 7, 2016
• First Posted (Estimated): February 10, 2016

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Depression
• Other Study ID Numbers: H-3-2013-203-D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO