Project Collabri for Treatment of Anxiety

NCT02678624 | Completed DMC

• 1 other identifier: H-3-2013-203-A
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Generalized Anxiety; Social Phobia; Panic Disorder

Outcome Measures

Primary Outcomes (1)

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

  The measure is self-reported

  At 6 months follow up after baseline

Secondary Outcomes (3)

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

  At 6 months follow up after baseline

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

  At 6 months follow up after baseline

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

  At 6 months follow up after baseline

Other Outcomes (24)

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

  At 15 months follow up after baseline

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

  At 15 months follow up after baseline

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

  At 15 months follow up after baseline

Study Arms (2)

Treatment according to the Collabri model

EXPERIMENTAL

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

Treatment as usual

NO INTERVENTION

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

Treatment according to the Collabri model OTHER

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.

Treatment according to the Collabri model

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Amager Hospital: lead

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, Denmark

Location

Related Publications (2)

• 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.

  PMID: 33203365 DERIVED

• 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.

  PMID: 28814317 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder; Phobia, Social; Panic Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Study Officials

• Lene F Eplov, MD PhD

  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: February 7, 2016
• First Posted: February 10, 2016
• Study Start: November 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2020
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)