Project Collabri for Treatment of Anxiety

Project Collabri. The Effects of a Danish Model of Collaborative Care for People With Anxiety in General Practice

The purpose of this study is to determine whether treatment of patients with anxiety according to the Collabri Model is more effective in reducing symptoms compared to treatment as usual (TAU)

Study Overview

• Status: Completed
• Conditions: Panic Disorder; Social Phobia; Generalized Anxiety
• Intervention / Treatment: Other: Treatment according to the Collabri model

Detailed Description

Background:

Depression and anxiety are common diseases often treated in general practice. However, there are obstacles for optimal treatment e.g. a lack of continuity in disease management, organized collaboration between primary and secondary care and access to psychotherapy. Previous collaborative care studies have shown significant improvements in treatment outcomes for patients with depression and anxiety in primary care; however studies have yet not been carried out in a Danish context. Thus, the Collabri-model for collaborative care for panic disorder, generalized anxiety, social phobia and depression has been developed. The model includes: a multi-professional approach to treatment including a care manager (e.g. a psychiatric nurse), enhanced inter-professional communication, scheduled monitoring and review and structured treatment plans.

Objective:

To investigate whether treatment according to the Collabri-model have an effect on symptoms for people with anxiety disorders.

Methods/design:

Three cluster-randomized, clinical trials are set up to investigate treatment according to the Collabri-model compared to treatment as usual for 364 patients diagnosed with panic disorder, generalized anxiety and social phobia respectively from general practices in the Capital Region of Denmark. For all studies, the primary outcome is anxiety symptoms measured with Beck Anxiety Inventory (BAI) at 6 months.

Results/discussion:

The results will contribute new knowledge on collaborative care for depression and anxiety disorders in Danish conditions.

• Study Type: Interventional
• Enrollment (Estimated): 406
• 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 to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 18+ years
• Danish speaking
• Diagnosis of current depression using the Mini International Neuropsychiatric Interview (MINI) (DSM IV) by researchers that have been trained in using MINI and according to the ICD-10 criteria or when diagnosed by GP after conference with a psychiatrist in Project Collabri
• 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 general practitioner
• Psychotic condition detected in the MINI and/or by general practitioner
• Patients with a diagnosis of dementia
• Pregnancy
• Alcohol or substance misuse that hinders the person participating in Collabri treatment as assessed by the practitioner or researcher at inclusion interview
• Patients that are in current psychological or psychiatric treatment due to anxiety or depression
• Patients with a pending disability pension case
• Patients who have been treated for anxiety or depression within the last 6 months
• For patients in the intervention group: Patients with depression who wants treatment cf. the Danish psychologist scheme and do not want the reference to the psychologist preceded by other treatment, cf. the Collabri model
• For patients in the intervention group: If the patient at the first point of contact with the general practitioner after inclusion by a research assistant is referred to treatment as a part of the secondary psychiatric care system.
• Patients who are assessed by the general practitioner as medically unstable making it impossible for the patient to adhere to treatment
• OCD, PTSD, bipolar affective disorder as assessed in the MINI and/or by the general practitioner

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: Treatment according to the Collabri model; Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder	Other: Treatment according to the Collabri model; The Collabri Model is a complex intervention and consists of a number of treatment modalities. The Collabri Model includes the following elements: A multi-professional approach to treatment including a care manager, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. It further integrates: Recruitment of staff with psychiatric experience, training of general practitioner and care manager, use of instruments for detection and follow-up, education and treatment of the patient, supervision from a psychiatric specialist, guided self-help, patient- and relative involvement and a stepped care approach to treatment where treatment is always commenced on the least invasive and least resource-demanding level.
No Intervention: Treatment as usual; Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)	The measure is self-reported	At 6 months follow up after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of depression measured by the Beck Depression Inventory (BDI)	The measure is self-reported	At 6 months follow up after baseline
Psychological stress measured with the Symptom Checklist (SCL-92)	The measure is self-reported	At 6 months follow up after baseline
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of anxiety measured by the Beck Anxiety Inventory (BAI)	The measure is self-reported	At 15 months follow up after baseline
Degree of depression measured by the Beck Depression Inventory (BDI)	The measure is self-reported	At 15 months follow up after baseline
Psychological stress measured with the Symptom Checklist (SCL-92)	The measure is self-reported	At 15 months follow up after baseline
Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Quality of life measured with the WHO-5 scale	The measure is self-reported	At 6 months follow up after baseline
Quality of life measured with the WHO-5 scale	The measure is self-reported	At 15 months follow up after baseline
Personal and social performance measured with the Personal and Social Performance scale (PSP)	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline
Personal and social performance measured with the Personal and Social Performance scale (PSP)	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline
Side effects measured by the PRISE questionnaire	The measure is self-reported	At 6 months follow up after baseline
Side effects measured by the PRISE questionnaire	The measure is self-reported	At 15 months follow up after baseline
Health-related quality of life measured with the EQ-5D	The measure is self-reported	At 6 months follow up after baseline
Health-related quality of life measured with the EQ-5D	The measure is self-reported	At 15 months follow up after baseline
Functional impairment measured with Sheehan Disability Scale (SDS)	The measure is self-reported	At 6 months follow up after baseline
Functional impairment measured with Sheehan Disability Scale (SDS)	The measure is self-reported	At 15 months follow up after baseline
Sick leave	The measure is obtained from the Danish DREAM database	At 6 months follow up after baseline
Sick leave	The measure is obtained from the Danish DREAM database	At 15 months follow up after baseline
Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 6 months follow up after baseline
Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 15 months follow up after baseline
Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 6 months follow up after baseline
Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale	The measure is self-reported	At 15 months follow up after baseline
Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)	The measure is self-reported	At 6 months follow up after baseline
Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)	The measure is self-reported	At 15 months follow up after baseline
Apathia	The measure is obtained through a semi-structured interview	At 6 months follow up after baseline
Apathia	The measure is obtained through a semi-structured interview	At 15 months follow up after baseline

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Curth NK, Brinck-Claussen UO, Hjorthoj C, Davidsen AS, Mikkelsen JH, Lau ME, Lundsteen M, Csillag C, Christensen KS, Jakobsen M, Bojesen AB, Nordentoft M, Eplov LF. Collaborative care for depression and anxiety disorders: results and lessons learned from the Danish cluster-randomized Collabri trials. BMC Fam Pract. 2020 Nov 18;21(1):234. doi: 10.1186/s12875-020-01299-3.
• Curth NK, Brinck-Claussen UO, Davidsen AS, Lau ME, Lundsteen M, Mikkelsen JH, Csillag C, Hjorthoj C, Nordentoft M, Eplov LF. Collaborative care for panic disorder, generalised anxiety disorder and social phobia in general practice: study protocol for three cluster-randomised, superiority trials. Trials. 2017 Aug 16;18(1):382. doi: 10.1186/s13063-017-2120-3.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: February 7, 2016
• First Submitted That Met QC Criteria: February 7, 2016
• First Posted (Estimated): February 10, 2016

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

• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social; Panic Disorder; Generalized Anxiety Disorder
• Other Study ID Numbers: H-3-2013-203-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO