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

Project Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Anxiety and Depression in General Practice

The aim of the study Collabri Flex is to:

• Develop a Danish model for collaborative care for patients with anxiety 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 anxiety in a randomized controlled design from selected endpoints.

Study Overview

• Status: Completed
• Conditions: Obsessive-Compulsive Disorder; Generalized Anxiety Disorder; Post Traumatic Stress Disorder; Panic Disorder; Social Phobia; Agoraphobia
• Intervention / Treatment: Behavioral: Collaborative care; Behavioral: Consultations-Liaison

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 anxiety.
• 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 at 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 Type: Interventional
• Enrollment (Actual): 302
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Mental Health Centre Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18+ years
• Danish speaking
• Diagnosis of current anxiety in the form of panic disorder, generalized anxiety, PTSD, agoraphobia, OCD or social phobia based on the Mini International Neuropsychiatric Interview (MINI) by care manager that have been trained in using MINI. Patients can be referred from the GP on the basis of panic disorder, generalized anxiety, social phobia, OCD, PTSD, agoraphobia or depression diagnosis
• 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 assessed in the MINI and/or by the GP
• Patients with a diagnosis of dementia
• Alcohol or substance misuse that will hinder the person's participation in Collabri treatment 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Collabri Flex; Collaborative care	Behavioral: Collaborative care; Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation, medication according to a stepped care model
Experimental: Consultation-Liaison; Consultations with general practitioner	Behavioral: Consultations-Liaison; Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported degree of anxiety	Measured by Beck Anxiety Inventory (BAI)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported degree of depression	Measured by Beck Depression Inventory (BDI-II)	6 months
Self-reported pychological stress	Measured by the Symptom Checklist SCL-90-R	6 months
Self-reported functional impairment	Measured by Sheehan Disability Scale (SDS)	6 months
Self-reported quality of life/well-being	Measured by WHO-5	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sick leave	Obtained from the DREAM database	6 months
Sick leave	Obtained from the DREAM database	18 months
Self-reported self-efficacy	Measured by the IPQ-R Scale (Personal control) and two subscales from the Chronic disease Selv-Efficacy Scales (SECD-32); Obtain help from Community, Family, Friends Scale and control Manage Depression Scale	6 months
Self-reported self-efficacy	Measured by the IPQ-R Scale (Personal control) and two subscales from the Chronic disease Selv-Efficacy Scales (SECD-32); Obtain help from Community, Family, Friends Scale and control Manage Depression Scale	18 months
Self-reported health-related quality of life	Measured by EQ-5D	6 months
Self-reported health-related quality of life	Measured by EQ-5D	18 months
Employment	Obtained from the DREAM database	6 months
Employment	Obtained from the DREAM database	18 months
Mental-health outpatient services	National patient register	6 months
Mental-health outpatient services	National patient register	18 months
Experience of support in recovery	Self-reported support in recovery (INSPIRE)	6 months
Patient satisfaction	Self-reported satisfaction with treatment (CSQ-8)	6 months
Self-reported degree of anxiety	Measured by Beck Anxiety Inventory (BAI)	18 months
Self-reported degree of depression	Measured by Beck Depression Inventory (BDI-II)	18 months
Self-reported pychological stress	Measured by the Symptom Checklist SCL-90-R	18 months
Self-reported functional impairment	Measured by Sheehan Disability Scale (SDS)	18 months
Self-reported quality of life/well-being	Measured by WHO-5	18 months

Collaborators and Investigators

• Sponsor: Amager Hospital
• Investigators: Principal Investigator: Lene Falgaard Eplov, MD,PhD, Research Unit, Mental Health Center Copenhagen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): March 29, 2021
• Study Completion (Actual): March 29, 2021

Study Registration Dates

• First Submitted: April 10, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 4, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Anxiety; Psychiatry; Collaborative care; General practitioner; Consultation-liaison
• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Phobic Disorders; Stress Disorders, Traumatic; Phobia, Social; Anxiety Disorders; Stress Disorders, Post-Traumatic; Obsessive-Compulsive Disorder; Panic Disorder; Agoraphobia; Generalized Anxiety Disorder
• Other Study ID Numbers: Collabri Flex - Anxiety

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No