Collabri Flex - Effect of Collaborative Care for People W... | NCT03113201

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

NCT03113201

Sponsor

Amager Hospital

Status

Completed

Last Update Posted

Feb 4, 2026Actual

Enrollment

389Actual

Phase

Not Applicable

Conditions

Depression

Interventions

Collaborative care
Consultations-Liaison

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2018Actual

Primary Completion Date

Mar 29, 2021Actual

Completion Date

Mar 29, 2021Actual

First Submitted Date

Apr 10, 2017

First Submission Date that Met QC Criteria

Apr 10, 2017

First Posted Date

Apr 13, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2026

Last Update Posted Date

Feb 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

389Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Collabri Flex	Experimental	Collaborative care	Behavioral: Collaborative care
Consultation-Liaison	Experimental	Consultations with general practitioner	Behavioral: Consultations-Liaison

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collaborative care	Behavioral	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported degree of depression	Measured by Beck Depression Inventory (BDI-II)	6 months

Secondary Outcomes

Measure	Description	Time Frame
Self-reported degree of anxiety	Measured by Beck anxiety Inventory (BAI)	6 months
Self-reported psychological stress	Measured by Symptom Checklist (SCL-90-R)

Other Outcomes

Measure	Description	Time Frame
Sick leave	Obtained from the DREAM database	6 months
Sick leave	Obtained from the DREAM database	18 months

Eligibility Module

Eligibility Criteria

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:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Lene F Eplov, MD, PhD	Research Unit, Mental Health Center Copenhagen	Principal Investigator

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40510804	Derived	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.
37395101

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders