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

NCT03113201 | Completed

• 1 other identifier: Collabri Flex - Depression
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Self-reported degree of depression

  Measured by Beck Depression Inventory (BDI-II)

  6 months

Secondary Outcomes (4)

• Self-reported degree of anxiety

  6 months

• Self-reported psychological stress

  6 months

• Self-reported functional impairment

  6 months

• Self-reported quality of life/well-being

  6 months

Other Outcomes (17)

• Sick leave

  6 months

• Sick leave

  18 months

• Self-reported self-efficacy

  6 months

Study Arms (2)

Collabri Flex

EXPERIMENTAL

Collaborative care

Behavioral: Collaborative care

Consultation-Liaison

EXPERIMENTAL

Consultations with general practitioner

Behavioral: Consultations-Liaison

Interventions

Consultations-Liaison BEHAVIORAL

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

Consultation-Liaison

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

Collabri Flex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Amager Hospital: lead

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, Denmark

Location

Related Publications (3)

• 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.

  PMID: 40510804 DERIVED

• 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.

  PMID: 37395101 DERIVED

• 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.

  PMID: 31653228 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Lene F Eplov, MD, PhD

  Research Unit, Mental Health Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Associate professor

Study Record Dates

• First Submitted: April 10, 2017
• First Posted: April 13, 2017
• Study Start: January 15, 2018
• Primary Completion: March 29, 2021
• Study Completion: March 29, 2021
• Last Updated: February 4, 2026

Record last verified: 2026-02

Locations

DK (1)