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CompletedNCT02678624Updated Feb 4, 2026

Project Collabri for Treatment of Anxiety

An interventional study of Treatment according to the Collabri model in Generalized Anxiety, Social Phobia and Panic Disorder, sponsored by Amager Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-04.

Sponsored by Amager Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
406
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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)

Read the 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.

02

Conditions studied

  • Generalized Anxiety
  • Social Phobia
  • Panic Disorder
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
406 participants (estimated)

Study arms

  • 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

  • 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.

Interventions

  • OtherTreatment 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.

05

What researchers measure

Primary outcomes

  1. Degree of anxiety measured by the Beck Anxiety Inventory (BAI)

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

Secondary outcomes

  1. Degree of depression measured by the Beck Depression Inventory (BDI)

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  2. Psychological stress measured with the Symptom Checklist (SCL-92)

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  3. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)

    The measure is obtained through a semi-structured interview

    Time frame: At 6 months follow up after baseline

Other outcomes

  1. Degree of anxiety measured by the Beck Anxiety Inventory (BAI)

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  2. Degree of depression measured by the Beck Depression Inventory (BDI)

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  3. Psychological stress measured with the Symptom Checklist (SCL-92)

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  4. Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)

    The measure is obtained through a semi-structured interview

    Time frame: At 15 months follow up after baseline

  5. Quality of life measured with the WHO-5 scale

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  6. Quality of life measured with the WHO-5 scale

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  7. Personal and social performance measured with the Personal and Social Performance scale (PSP)

    The measure is obtained through a semi-structured interview

    Time frame: At 6 months follow up after baseline

  8. Personal and social performance measured with the Personal and Social Performance scale (PSP)

    The measure is obtained through a semi-structured interview

    Time frame: At 15 months follow up after baseline

  9. Side effects measured by the PRISE questionnaire

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  10. Side effects measured by the PRISE questionnaire

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  11. Health-related quality of life measured with the EQ-5D

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  12. Health-related quality of life measured with the EQ-5D

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  13. Functional impairment measured with Sheehan Disability Scale (SDS)

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  14. Functional impairment measured with Sheehan Disability Scale (SDS)

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  15. Sick leave

    The measure is obtained from the Danish DREAM database

    Time frame: At 6 months follow up after baseline

  16. Sick leave

    The measure is obtained from the Danish DREAM database

    Time frame: At 15 months follow up after baseline

  17. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  18. Self-efficacy measured with the subscale "Obtain Help from Community, Family, Friends" from the Chronic Disease Self-Efficacy Scale

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  19. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  20. Self-efficacy measured with the subscale "Control/Manage Depression Scale" from the Chronic Disease Self-Efficacy Scale

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  21. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)

    The measure is self-reported

    Time frame: At 6 months follow up after baseline

  22. Self-efficacy measured with the subscale "Personal Control" from The Revised Illness Perception Questionnaire (IPQ-R)

    The measure is self-reported

    Time frame: At 15 months follow up after baseline

  23. Apathia

    The measure is obtained through a semi-structured interview

    Time frame: At 6 months follow up after baseline

  24. Apathia

    The measure is obtained through a semi-structured interview

    Time frame: At 15 months follow up after baseline

06

Study locations

1 site
  • Mental Health Centre Copenhagen
    Copenhagen, Denmark
07

References and documents

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. PubMed 33203365 ↗
  • 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. PubMed 28814317 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT02678624
Lead sponsor
Amager Hospital
Responsible party
Lene Falgaard Eplov (Head of Research, Associate professor, Amager Hospital) — Principal investigator
First posted
Feb 10, 2016
Start date
Nov 2014
Primary completion
Jul 2017
Completion
Jul 2020
Last update
Feb 4, 2026

Study contacts

Lene F Eplov, MD PhD
principal investigator · Mental Health Center Copenhagen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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