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CompletedNCT03113201Collabri FlexUpdated Feb 4, 2026

Collabri Flex - Effect of Collaborative Care for People With Depression in General Practice

An interventional study of Collaborative care and Consultations-Liaison in Depression, sponsored by Amager Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Amager Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
389
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The aim of the study Collabri Flex is to:

  • Develop a Danish model for collaborative care for patients with depression in general practice, based on past experience gained in the Collabri Project.
  • Examine the impact of this model compared with liaison-consultation for people with depression in a randomized controlled design from selected endpoints.
Read the detailed description

The Collabri Flex model for Collaborative Care takes point of departure in the earlier study Collabri. It is changed according to gathered information under the first study of the Collabri model in order to achieve a Danish Collaborative Care model easier to implement.

The aims of Project Collabri Flex are to:

  • Develop a flexible model for collaborative care (the Collabri Flex model) for patients with depression.
  • Study the effects of this Collabri Flex model against consultation liaison in a randomized design on selected outcomes.

In Collabri the treatment is in line with a set of general treatment principles relevant for collaborative care interventions. The patients in the intervention group are offered cognitive behavioral therapy (CBT), psychoeducation and medication according to a stepped care model by a care manager refering to the general practitioner.

The Collabri Flex study is set up as a researcher-blinded individually randomized controlled trial with participation of an intervention group (treatment according to the Collabri Flex model) and a consultation liaison group.

This study will contribute with new knowledge on collaborative care interventions in a Scandinavian context.

02

Conditions studied

  • Depression

Keywords

  • Depression
  • Collaborative care
  • Care manager
  • Anxiety
  • Psychiatry
  • Consultation-liaison
  • General practitioner
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's enrollment of 389 is above the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Amager Hospital is the lead sponsor of 21 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Danish speaking
  • Diagnosis of current depression based on the Mini International Neuropsychiatric Interview (MINI) by care managers that have been trained in using MINI in close collaboration with the psychiatrist/psychologist.
  • The patient has given her/his written to participate in the trial at the described terms

Exclusion criteria

Exclusion Criteria:

  • High risk of suicide assessed in the Mini International Neuropsychiatric Interview (MINI) and/or by the GP
  • Psychotic condition detected in the MINI and/or by the GP
  • Patients with a diagnosis of dementia
  • Alcohol or substance misuse that hinders the person participating in Collabri treat-ment as assessed by the practitioner or care manager at inclusion interview
  • If the patient has been referred or is recommended referral to secondary care treatment (mental health center) or psychiatrist in private practice
  • Patients who are assessed by the GP as medically unstable making it impossible for the patient to adhere to treatment
  • Bipolar affective disorder as assessed in the MINI and/or by the GP
  • Pregnancy

For patients in the Collabri Flex group:

  • Patients with depression who wants treatment cf. the psychologist scheme (Psykologordningen) or similar treatment and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP
  • Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
389 participants (actual)

Study arms

  • Experimental
    Collabri Flex

    Collaborative care

    Behavioral: Collaborative care

  • Experimental
    Consultation-Liaison

    Consultations with general practitioner

    Behavioral: Consultations-Liaison

Interventions

  • BehavioralCollaborative care

    Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model

  • BehavioralConsultations-Liaison

    Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

06

What researchers measure

Primary outcomes

  1. Self-reported degree of depression

    Measured by Beck Depression Inventory (BDI-II)

    Time frame: 6 months

Secondary outcomes

  1. Self-reported degree of anxiety

    Measured by Beck anxiety Inventory (BAI)

    Time frame: 6 months

  2. Self-reported psychological stress

    Measured by Symptom Checklist (SCL-90-R)

    Time frame: 6 months

  3. Self-reported functional impairment

    Measured by Sheehan disability Scale (SDS)

    Time frame: 6 months

  4. Self-reported quality of life/well-being

    Measured by WHO-5

    Time frame: 6 months

Other outcomes

  1. Sick leave

    Obtained from the DREAM database

    Time frame: 6 months

  2. Sick leave

    Obtained from the DREAM database

    Time frame: 18 months

  3. Self-reported self-efficacy

    Measured by personal control (IPQ-R scale) and two subscales from the Chronic Disease Self-Efficacy Scales; Obtain help from Comunity, Family, Friends Scale and Control/manage Depression Scale

    Time frame: 6 months

  4. Self-reported self-efficacy

    Measured by personal control (IPQ-R scale) and two subscales from the Chronic Disease Self-Efficacy Scales; Obtain help from Comunity, Family, Friends Scale and Control/manage Depression Scale

    Time frame: 18 months

  5. Self-reported health-related quality of life

    Measured by EQ-5D

    Time frame: 6 months

  6. Self-reported health-related quality of life

    Measured by EQ-5D

    Time frame: 18 months

  7. Self-reported experience of support in recovery

    Experience of support in recovery (INSPIRE)

    Time frame: 6 months

  8. Employment

    Obtained from the DREAM database

    Time frame: 6 months

  9. Employment

    Obtained from the DREAM database

    Time frame: 18 months

  10. Mental-health outpatient services

    Obtained from LPR

    Time frame: 6 months

  11. Mental-health outpatient services

    Obtained from LPR

    Time frame: 18 months

  12. Patient satisfaction

    Self-reported experience of satisfaction with treatment (CSQ-8)

    Time frame: 6 months

  13. Self-reported degree of depression

    Measured by Beck Depression Inventory (BDI-II)

    Time frame: 18 months

  14. Self-reported degree of anxiety

    Measured by Beck anxiety Inventory (BAI)

    Time frame: 18 months

  15. Self-reported psychological stress

    Measured by Symptom Checklist (SCL-90-R)

    Time frame: 18 months

  16. Self-reported functional impairment

    Measured by Sheehan disability Scale (SDS)

    Time frame: 18 months

  17. Self-reported quality of life/well-being

    Measured by WHO-5

    Time frame: 18 months

07

Study locations

1 site
  • Mental Health Centre Copenhagen
    Copenhagen, Denmark
08

References and documents

Publications

  • Curth NK, Bjorkedal STB, Hjorthoj C, Brinck-Claussen U, Jorgensen KB, Rosendal S, Bojesen AB, Nordentoft M, Eplov LF. Collaborative Care Versus Consultation Liaison for Patients With Depression or Anxiety Disorders in General Practice in Denmark: 18-Month Follow-Up From the Collabri Flex Trials. Depress Anxiety. 2025 Jun 5;2025:2909617. doi: 10.1155/da/2909617. eCollection 2025. PubMed 40510804 ↗
  • Curth NK, Hjorthoj C, Brinck-Claussen U, Jorgensen KB, Rosendal S, Bojesen AB, Nordentoft M, Eplov LF. The effects of collaborative care versus consultation liaison for anxiety disorders and depression in Denmark: two randomised controlled trials. Br J Psychiatry. 2023 Sep;223(3):430-437. doi: 10.1192/bjp.2023.77. PubMed 37395101 ↗
  • Curth NK, Brinck-Claussen U, Jorgensen KB, Rosendal S, Hjorthoj C, Nordentoft M, Eplov LF. Collaborative care vs consultation liaison for depression and anxiety disorders in general practice: study protocol for two randomized controlled trials (the Danish Collabri Flex trials). Trials. 2019 Oct 25;20(1):607. doi: 10.1186/s13063-019-3657-0. PubMed 31653228 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03113201
Lead sponsor
Amager Hospital
Responsible party
Lene Falgaard Eplov (Head of Research, Associate professor, Amager Hospital) — Principal investigator
First posted
Apr 13, 2017
Start date
Jan 15, 2018
Primary completion
Mar 29, 2021
Completion
Mar 29, 2021
Last update
Feb 4, 2026

Study contacts

Lene F Eplov, MD, PhD
principal investigator · Research Unit, Mental Health Center Copenhagen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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