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

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.

Conditions studied

Depression

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Keywords

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

Who can participate

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

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 informed consent 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

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).

What researchers measure

Primary outcomes

Self-reported degree of depression
Measured by Beck Depression Inventory (BDI-II)
Time frame: 6 months

Secondary outcomes

Self-reported degree of anxiety
Measured by Beck anxiety Inventory (BAI)
Time frame: 6 months
Self-reported psychological stress
Measured by Symptom Checklist (SCL-90-R)
Time frame: 6 months
Self-reported functional impairment
Measured by Sheehan disability Scale (SDS)
Time frame: 6 months
Self-reported quality of life/well-being
Measured by WHO-5
Time frame: 6 months

Other outcomes

Sick leave
Obtained from the DREAM database
Time frame: 6 months
Sick leave
Obtained from the DREAM database
Time frame: 18 months
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
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
Self-reported health-related quality of life
Measured by EQ-5D
Time frame: 6 months
Self-reported health-related quality of life
Measured by EQ-5D
Time frame: 18 months
Self-reported experience of support in recovery
Experience of support in recovery (INSPIRE)
Time frame: 6 months
Employment
Obtained from the DREAM database
Time frame: 6 months
Employment
Obtained from the DREAM database
Time frame: 18 months
Mental-health outpatient services
Obtained from LPR
Time frame: 6 months
Mental-health outpatient services
Obtained from LPR
Time frame: 18 months
Patient satisfaction
Self-reported experience of satisfaction with treatment (CSQ-8)
Time frame: 6 months
Self-reported degree of depression
Measured by Beck Depression Inventory (BDI-II)
Time frame: 18 months
Self-reported degree of anxiety
Measured by Beck anxiety Inventory (BAI)
Time frame: 18 months
Self-reported psychological stress
Measured by Symptom Checklist (SCL-90-R)
Time frame: 18 months
Self-reported functional impairment
Measured by Sheehan disability Scale (SDS)
Time frame: 18 months
Self-reported quality of life/well-being
Measured by WHO-5
Time frame: 18 months

Study locations

1 site

Mental Health Centre Copenhagen
Copenhagen, Denmark

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

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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