DepressionCollabri FlexNCT03113201
Collabri Flex - Effect of Collaborative Care for People With Depression in General Practice
A study testing Collaborative care and Consultations-Liaison in people with Depression, run by Amager Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Collaborative care and Consultations-Liaison
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2018to 29 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent to participate in the trial at the described terms
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice
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.
- Conditions
- Depression
- Being tested
- Collaborative care, Consultations-Liaison
- Keywords
- Depression, Collaborative care, Care manager, Anxiety, Psychiatry, Consultation-liaison, General practitioner
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative careBehavioural
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
Consultations-LiaisonBehavioural
Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).
| Study group | Role | What they receive |
|---|---|---|
| Collabri Flex | Experimental | Collaborative care Receives: Behavioral: Collaborative care |
| Consultation-Liaison | Experimental | Consultations with general practitioner Receives: Behavioral: Consultations-Liaison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported degree of depression
Measured by Beck Depression Inventory (BDI-II)
Measured: 6 months
Secondary outcomes (4)
Self-reported degree of anxiety
Measured by Beck anxiety Inventory (BAI)
Measured: 6 months
Self-reported psychological stress
Measured by Symptom Checklist (SCL-90-R)
Measured: 6 months
Self-reported functional impairment
Measured by Sheehan disability Scale (SDS)
Measured: 6 months
Self-reported quality of life/well-being
Measured by WHO-5
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start15 Jan 2018
- Primary completion29 Mar 2021
- Study completion29 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lene Falgaard Eplov, Amager Hospital
- Investigators
- Lene F Eplov, MD, PhD, Principal investigator, Research Unit, Mental Health Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113201
- Sponsor's protocol ID
- Collabri Flex - Depression
- Acronym
- Collabri Flex
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2017
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 40510804Curth 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 37395101Curth 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice
- ClinicalTrials.gov ID
- NCT03113201
- Acronym / sponsor ID
- Collabri Flex / Collabri Flex - Depression
- Conditions
- Depression
- Keywords
- Depression, Collaborative care, Care manager, Anxiety, Psychiatry, Consultation-liaison, General practitioner
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 29 Mar 2021 (actual)
- Study completion
- 29 Mar 2021 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collabri Flex | Experimental | Behavioral: Collaborative careCollaborative care |
| Consultation-Liaison | Experimental | Behavioral: Consultations-LiaisonConsultations with general practitioner |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 informed consent to participate in the trial at the described terms
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative careCollaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model | Behavioural | Collabri Flex |
| Consultations-LiaisonConsultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist). | Behavioural | Consultation-Liaison |
Primary outcome
Self-reported degree of depression
Time frame: 6 months
Measured by Beck Depression Inventory (BDI-II)
4 secondary outcomes
Self-reported degree of anxiety
Time frame: 6 months
Self-reported psychological stress
Time frame: 6 months
Self-reported functional impairment
Time frame: 6 months
Self-reported quality of life/well-being
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 40510804Curth 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.
- Derived from this study: PubMed 37395101Curth 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.
- Derived from this study: PubMed 31653228Curth 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.
- Individual participant dataSharing planned: Undecided
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lene F Eplov, MD, PhD principal investigator
Research Unit, Mental Health Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care and Consultations-Liaison in people with Depression, run by Amager Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported degree of depression (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03113201, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.